Depression

Evidence Reviewed as of before: 04-01-2018
Author(s): Tatiana Ogourtsova PhD OT; Annabel McDermott OT; Chelsea Hellings BA; Katherine Salter BA; Sanjit Bhogal MSc; Robert Teasell MD; Norine Foley BASc; Mark Speechley PhD; Elissa Sitcoff BSC, BA; Anita Menon, MSc
Patient/Family Information Table of contents

Introduction

A variety of emotional and behavioural disorders may develop following stroke. Depression, the most common emotional disorder, may affect up to 40% of all patients with stroke. Depression affects every aspect of a person’s life, such as their body, emotions, thoughts and mood. It is much more complex than simply “feeling blue” and is characterized by a persistent and pervasive feeling of sadness or hopelessness. Depression can also be associated with a combination of the following symptoms: poor appetite and weight loss (or conversely weight gain), sleep disturbances (insomnia or hypersomnia), constipation, psychomotor retardation (or conversely agitation), difficulties with concentration and thinking, withdrawal from interpersonal contact, feelings of guilt or self-blame, diminished interest or pleasure in most or all activities, and recurrent thoughts of death or suicidal ideation. Depression can occur early after stroke or in the years following. Detection of post-stroke depression is often overlooked so it is important to use reliable measures when evaluating the patient after stroke.

Various interventions exist for post-stroke depression and are reviewed in this module. These include psychosocial support programs (individual, group or community), cognitive-behavioral therapy, multimodal interventions (exercise + psychoeducation), neuro-linguistic programming therapy, speech therapy, patient-centered counselling, art therapy and wellness therapies (e.g. relaxation therapy, forest therapy, Yoga, Tai Chi, meditation, enriched environments therapy).

Note: Extensive research has investigated the benefits of various drugs such as heterocyclic antidepressants, psychostimulants, and selective serotonin reuptake inhibitors (SSRIs) to treat post-stroke depressionDrug studies are not covered in this module.

Patient/Family Information

Authors: Ying Ying Kan, BSc OT; Chantal Barakat, BSc OT; Martine Sourdif, BSc OT

Since my stroke, I feel sad and depressed. Am I normal?

Mood swings and depression are very common in patients with stroke. In fact, at least 1 person out of 4 will feel depressed or moody after a stroke. Some studies have shown that the rate of depression is even higher, as high as 1 person out of 2.

What is depression after a stroke (post-stroke depression)?

Anyone who has experienced a stroke would agree that it is a big life change. Suddenly daily activities like washing and dressing become a challenge. It is a very difficult experience that can affect your emotions.

What are mood swings?

After a stroke, you may experience rapid changes in mood. For example, you may feel happy, and then suddenly very sad. You may feel that your emotions are like a roller coaster. Some people might cry and laugh at inappropriate times.

Just like depression, these mood swings can appear when there is an injury to a specific area of your brain.

When would depression appear after a stroke?

The time after stroke that depression can appear varies. Some people become depressed shortly after the stroke, in the hours or days later. Others will experience depression much later after stroke, after as long as 3 years.

Are my mood swings/depression caused by my stroke?

It is possible that your mood swings or depression are effects of your stroke. There are two possible explanations of depression post-stroke.

  • Injury to your brain
    Indeed, some areas of your brain control your mood and emotions. If one of these areas is affected by the stroke, it can lead to mood swings or depression.There are debates on whether the site of the lesion is related to depression. Some research indicates that individuals who have a stroke in a specific lobe (frontal) are more likely to experience depression. Other research argues that it is the side of the brain (left or right) where the stroke happened that matters.
  • Changes in your life skills and abilities
    Changes in your physical abilities after a stroke can be very difficult to accept. You may find rehabilitation overwhelming. Everyday tasks now require extra efforts. These feelings of sadness can lead to depression.The real cause of depression is probably a combination of these two theories. That is, depression is due in part to the damages in the brain area and also due to the changes in your life skills and abilities caused by the stroke.

How do I know if I am depressed? What are the common signs of depression after a stroke?

People who are depressed share some common traits such as:

  • getting angry easily or crying easily.
  • sleeping too much or too little.
  • feeling down.
  • being slow mentally.
  • feeling guilty.
  • feeling less hopeful about the future.
  • not wanting to see friends.
  • thinking about ending one’s life.

Is it easy to detect depression after a stroke?

It is often difficult to detect depression in a person that has had a stroke. After a stroke, most people will have physical and cognitive problems. Often the treatment will focus more on those two aspects and will forget to include the person’s feelings. Sometimes, people who had a stroke have problems speaking or understanding words; this makes sharing feelings very hard. Thus, it is hard to detect depression as well. Family and close friends are often the first ones to detect signs of depression in their loved one. This is because they know the person better than any health care workers.

How is the diagnosis of depression after a stroke made?

Your clinician may ask you a series of questions or have you fill out a questionnaire. This will help to identify any signs of depression.

Are there different kinds of therapies for depression?

There are many different therapies available for depression after stroke. Those include:

  • Art therapy activities to stimulate cognition, physical state, emotion, communication, social relation and spiritual dimensions (e.g. meditation with music, singing activity, group-healing circle, positive thinking, story sharing).
  • Coordinated discharge care – regular follow-up with a stroke nurse following discharge.
  • Counselling / stroke counselling and education support program –recommendations, education, and advice.
  • Enriched environment inpatient program – equipment and organization of a stimulating environment as well as activities in the medical ward: computers with internet connection, Skype access, Gaming Therapy, library with reading material, music station, life-size mirrors, simulated shopping corner with groceries, electronic payment machine, automatic back teller machine, board games, puzzles, chess, painting, and wood workshop.
  • Exercise – physical exercises (e.g. walking, stationary bicycle, weight lifting).
  • Forest therapy – taking long walks in the forest/nature, meditate in the forest.
  • Multimodal interventions –physical exercises and education together.
  • Neurolinguistic programming therapy – techniques aimed at shifting negative thoughts or beliefs/bad moods, increasing mental energy, releasing pressure and relaxation
  • Psychotherapy/Cognitive Behavioral Therapy – teaches people how to change their thinking in order to change their behavior.
  • Relaxation – listening to soothing music and practice meditation.
  • Speech therapy – training to help people with speech/language problems and depression to speak more clearly or express themselves in different ways that are more comprehensible.
  • Supportive home rehabilitation programs – home exercises and education.
  • Tai Chi – slow movement exercises and meditation.
  • Yoga – breath control, simple meditation, and adoption of specific bodily postures.

What depression therapies work for stroke?

Depression therapies have been examined using high quality research studies and were shown to improve depression (and other important domains such as cognitive function, anxiety, quality of life) in some patients after stroke.

In particular, for patients with acute stroke (up to 1 month after stroke): counselling, , multimodal interventions (exercises + education), neurolinguistic programming therapy and supportive home rehabilitation programs have been shown to be useful to improve depression, and other abilities/domains.

For patients with subacute stroke (from 1 to 6 months after stroke), exercise has been shown to be useful to improve depression.

For patients with chronic stroke (more than 6 months after stroke), forest therapy and relaxation have been shown to be useful to improve anxiety and depression.

For patients with stroke across the recovery continuum (acute, subacute and/or chronic), art therapy, cognitive behavioral therapy, and enriched environment inpatient program have been shown to be useful to improve depression/mood/anxiety.

What can I expect?

Your therapist will discuss with you what depression therapy is most suitable for you. How often and for how long the therapy is provided for depends on the nature of therapy.

Who provides the treatment?

Different health-care providers can administer depression therapies: neuropsychologist, nurse, occupational therapists, physical therapists, psychologist and speech language pathologist.

Are there any side effects or risks?

Depression therapies are usually administered by a trained health professional at a rehabilitation clinic or at home (in cases of home programs). Your therapist will monitor your reactions to the therapy closely. It is important to report to your therapist any changes in your feelings or thoughts. Your therapist will adjust the nature, intensity and the duration of therapy according to your ability, endurance and progress.

Can sleeping and eating well help?

Sure! Having proper meals and good sleep will give you more energy during your recovery. You may feel you are not hungry or you have difficulty sleeping. This is common with people who are depressed.

Should I exercise?

Yes. It is important, however, to know your own abilities and limitations when you are exercising.

If your doctor agrees, you may start an exercise class. Exercising releases an hormone (endorphin) that will make you feel good.

For information about exercise after a stroke, see Aerobic Exercise Late After Stroke or Aerobic Exercise Early After Stroke.

Should I continue my rehabilitation program if I do not feel like doing it?

Yes. It is possible that you may not feel motivated to go to your rehabilitation sessions. It is hard and demands a lot of energy. However, rehabilitation sessions will teach you many things that will help you feel independent (dressing, walking). You will be proud of yourself and feel more motivated.

Why should I bother seeing people?

Having a social life has been shown to have a positive impact on helping depression. It is very important that you continue having hobbies, such as playing cards, doing cross-words, or going outside. Your occupational therapist can show you possible ways to adapt your hobby, since certain activities may need to be modified after a stroke.

Is it possible to speak to someone who had a stroke?

Support groups are available in some regions for people who have had a stroke. You can also find stories about people who have had problems similar to yours. Consult your National Stroke Association:

Canada: Heart and Stroke Foundation

How does my depression impact on my recovery?

Indeed, being depressed may slow down your recovery. Depression may make you feel less motivated and more tired, and also may cause you to have trouble concentrating. All these symptoms of depression will slow down your recovery capacities. Many studies have shown that people with depression after a stroke do not get better as quickly as people who are not depressed. The extent to which depression can affect recovery is not really known. It seems that both physical loss and depression can act on recovery.

Will depression ever get better?

Some studies show that people who are depressed can get better. On average, the duration of major depression in people who have had a stroke is under a year. However, sometimes depression can return, so it is important to watch for the signs.

How long does it take to recover from depression after a stroke?

Recovery from depression after a stroke takes time. It can vary a lot from one person to another. For example, medication can take a few weeks to work. With treatment, people who are depressed usually get better. As mentioned above, the average duration of major depression for people who have had a stroke is a year.

Does depression lead to stroke?

Not everybody who is depressed will experience a stroke. However, some studies have shown that being depressed may increase the chances of having a stroke. When heart disease, hypertension, diabetes, and tobacco use are all ruled out, depressed people are 2.6 times more likely to report a stroke.

If I was depressed before my stroke, am I more likely to be depressed after my stroke?

Yes, if you were depressed before your stroke, you have more chances to be depressed after. This is one of the risk factors linked with depression after the stroke.

As a care provider, what can I do to avoid being depressed too?

The care provider is the one who takes care of the person who has had a stroke. Usually this person is a family member, a spouse, or a close friend. Often, the care provider will be so devoted to their loved one that they will forget to take care of their own needs.

When your loved one is depressed after a stroke, it is more difficult for both of you to stay positive, so it is especially important that you both receive support. Thus, it is very important that you, as a care provider, take time for yourself everyday. Find a moment during the day to do an activity you like such as reading or shopping. Moreover, you should continue to see your friends to share your feelings and refresh your mind.

I would like to know more about depression and stroke

Understanding how depression and stroke happen can reassure you. There are many resources online. Your health care provider can help answer your specific questions.

Clinician Information

Note: When reviewing the findings, it is important to note that they are always made according to randomized clinical trial (RCT) criteria – specifically as compared to a control group. To clarify, if a treatment is “effective” it implies that it is more effective than the control treatment to which it was compared. Non-randomized studies are no longer included when there is sufficient research to indicate strong evidence (level 1a) for an outcome.

The present module reviews 28 RCTs including 22 high quality and 6 fair quality studies. Studies were included in the module only if depression and/or mood/affect were the primary outcomes. Secondary outcomes have also been included in this module.

Other StrokEngine modules also include depression as an outcome of the intervention: Acupuncture, Aerobic Exercise, Music-based Interventions, Transcranial Magnetic Stimulation and Virtual Reality-Upper Extremity. Please refer to those modules for more details.

Extensive research has investigated the benefits of various drugs such as heterocyclic antidepressants, psychostimulants, and selective serotonin reuptake inhibitors (SSRIs) to treat post-stroke depression. Drug studies are not covered in this module; other types of rehabilitative interventions to treat post-stroke depression will be explored.

Results Table

View results table

Outcomes

Acute phase - Counseling

Depression
Effective
1b

One high quality RCT (Watkins et al., 2007; 2011) investigated the effect of counseling on depression in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual stroke care. Depression was measured by the Yale Single Question at follow-up (3 months and 12 months post-stroke). Significant between-group difference was found at 3 months post-stroke, favoring counseling vs. no treatment. This difference did not remain significant at 12 months.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is more effective than no treatment in improving depression in patients with acute stroke, in the short term.

Functional independence
Not effective
1b

One high quality RCT (Watkins et al., 2007; 2011) investigated the effect of counseling on functional independence in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual stroke care. Functional independence was measured by the Barthel Index at follow-up (3 months and 12 months post-stroke). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is not more effective than no treatment in improving functional independence in patients with acute stroke.

Instrumental activities of daily living
Not effective
1b

One high quality RCT (Watkins et al., 2011) investigated the effect of counseling on instrumental activities of daily living (IADLs) in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual stroke care. IADLs were measured by the Nottingham Extended Activities of Daily Living at follow-up (12 months post-stroke). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is not more effective than no treatment in improving instrumental activities of daily living in patients with acute stroke.

Mood and affect
Effective
1b

One high quality RCT (Watkins et al., 2007; 2011) investigated the effect of counseling on mood and affect in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual stroke care. Mood and affect was measured by the General Health Questionnaire-28 at follow-up (3 months and 12 months post-stroke). Significant between-group difference was found at both follow-up points, favoring counseling vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is more effective than no treatment in improving mood and affect in patients with acute stroke.

Recovery beliefs and expectations
Not effective
1b

One high quality RCT (Watkins et al., 2007; 2011) investigated the effect of counseling on recovery beliefs and expectations in patients with acute stroke. This high quality RCT randomized patients to receive patient-centred counseling or no treatment for 4 weeks; both groups received usual strokecare. Recovery beliefs and expectations were measured by the Stroke Expectations Questionnaire (Beliefs, Expectations, Differences between beliefs and expectations) at follow-up (3 months and 12 months post-stroke). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that counseling is not more effective than no treatment in improving recovery beliefs and expectations in patients with acute stroke.

Acute phase – Individual multimodal home intervention

Cognitve function
Not effective
1b

One high quality RCT (Chaiyawat, Kulkantrakorn & Sritipsukho, 2009) and one follow-up analysis (Chaiyawat & Kulkantrakorn, 2012) investigated the effect of an individual multimodal home intervention on cognitive function in patients with acute stroke. This high quality RCT randomized patients to receive an individual multimodal home intervention or standard care. Cognitive function was measured by the Thai Mental State Examination at post-treatment (3 months) and at follow-up (24 months post-discharge from hospital). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one follow-up report that an individual multimodal home intervention is not more effective than a comparison intervention (standard care) in improving cognitive function in patients with acute stroke.

Depression
Effective
1b

One high quality RCT (Chaiyawat, Kulkantrakorn & Sritipsukho, 2009) and one follow-up analysis (Chaiyawat & Kulkantrakorn, 2012) investigated the effect of an individual multimodal home intervention on depression in patients with acute stroke. This high quality RCT randomized patients to receive an individual multimodal home intervention or standard care. Depression was measured by the Hospital Anxiety and Depression Scale (HADS: depression) at post-treatment (3 months) and at follow-up (24 months post-discharge from hospital). Significant between-group difference was found at both time points, favoring individual multimodal home rehabilitation vs. standard care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one follow-up report that an individual multimodal home intervention is more effective than a comparison intervention (standard care) in improving depression in patients with acute stroke.

Functional independence
Effective
1b

One high quality RCT (Chaiyawat, Kulkantrakorn & Sritipsukho, 2009) and one follow-up analysis (Chaiyawat & Kulkantrakorn, 2012) investigated the effect of an individual multimodal home intervention on functional independence in patients with acute stroke. This high quality RCT randomized patients to receive an individual multimodal home intervention or standard care. Functional independence was measured by the Barthel Index (BI) and the Modified Rankin Scale (MRS) at post-treatment (3 months) and at follow-up (24 months post-discharge from hospital, BI only). Significant between-group differences were found at post-treatment (BI, MRS) and at follow-up (BI), favoring individual multimodal home intervention vs. standard care.
Note: The Modified Rankin Scale measure was not used at the time of the follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one follow-up repot that an individual multimodal home intervention is more effective than a comparison intervention (standard care) in improving functional independence in patients with acute stroke.

Health related quality of life
Effective
1b

One high quality RCT (Chaiyawat, Kulkantrakorn & Sritipsukho, 2009) investigated the effect of an individual multimodal home intervention on health-related quality of life in patients with acute stroke. This high quality RCT randomized patients to receive an individual multimodal home intervention or standard care. Health-related quality of life was measured by the EQ-5D at post-treatment (3 months). Significant between-group difference was found, favoring individual multimodal home intervention vs. standard care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an individual multimodal home intervention is more effective than a comparison intervention (standard care) in improving health-related quality of life in patients with acute stroke.

Acute phase - Multimodal intervention

Anxiety
Not effective
1a

Two high quality RCTs (Ihle-Hansen et al., 2014; Faulkner et al., 2015) investigated the effect of a multimodal intervention on anxiety in patients with acute stroke.

The first high quality RCT (Ihle-Hansen et al., 2014) randomized patients to receive a healthy lifestyle promotion program or standard care. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety subscale) at 1-year post-stroke (follow-up). No significant between-group difference was found.

The second high quality RCT (Faulkner et al., 2015) randomized patients to receive an exercise + education program or standard care. Anxiety was measured by the HADS (Anxiety subscale) at post-treatment (8 weeks) and at follow-up (12 months). No significant between-group difference was found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that multimodal interventions are not more effective than a comparison intervention (standard care) in reducing anxiety in patients with acute stroke.

Depression
Not effective
1a

Two high quality RCTs (Ihle-Hansen et al., 2014; Faulkner et al., 2015) investigated the effect of a multimodal intervention on depression in patients with acute stroke.

The first high quality RCT (Ihle-Hansen et al., 2014) randomized patients to receive a healthy lifestyle promotion program or standard care. Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression subscale) at 1-year post-stroke follow-up. No significant between-group difference was found.

The second high quality RCT (Faulkner et al., 2015) randomized patients to receive an exercise + education program or standard care. Depression was measured by the HADS (Depression subscale) and the Profile of Mood States (PMS – Depression subscale) at post-treatment (8 weeks) and follow-up (12 months). There were no significant between-group difference at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that multimodal interventions are not more effective than a comparison intervention (standard care) in improving depression in patients with acute stroke.

Functional independence
Effective
2a

One fair quality RCT (Wu et al., 2012) investigated the effect of a multimodal intervention on functional independence in patients with acute stroke. This fair quality RCT randomized patients to receive psychology + physical rehabilitation or no treatment. Functional independence was measured by the Barthel Index at 90 days (follow-up). Significant between-group difference was found, favoring multimodal intervention vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that multimodal intervention is more effective than no treatment in improving functional independence in patients with acute stroke.

Health related quality of life
Effective
1b

One high quality RCT (Faulkner et al., 2015) investigated the effect of a multimodal intervention on health-related quality of life in patients with acute stroke. This high quality RCT randomized patients to receive an exercise + education program or standard care. Change in health-related quality of life was measured by the Short-Form 36 (SF-36 – Physical component, Mental component, Mental health, Social functioning, Global health, Role physical, Role emotional, Vitality, Bodily pain, Physical functioning subscales) from baseline to post-treatment (8 weeks) and to follow-up (12 months). Significant between-group difference was found on some aspects of health-related quality of life from baseline to post-treatment (SF-36 – Physical component, Global health, Role physical, Vitality, Physical functioning) favoring multimodal intervention vs. standard care. This difference was not maintained at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention is more effective than a comparison intervention (standard care) in improving some aspects of health-related quality of life in patients with acute stroke, in the short term.

Impairments
Effective
2a

One fair quality RCT (Wu et al., 2012) investigated the effect of a multimodal intervention on impairments in patients with acute stroke. This fair quality RCT randomized patients to receive psychology + physical rehabilitation or no treatment. Impairments were measured by the European Stroke Scale at day 3 and day 21 of treatment. While there were no significant difference between groups at day 3 of treatment, significant between-group difference was found at day 21, favoring multimodal intervention vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that a multimodal intervention is more effective than no treatment in improving impairments in patients with acute stroke.

Mood and affect
Not effective
1a

Two high quality RCTs (Ihle-Hansen et al., 2014; Faulkner et al., 2015) and one fair quality RCT (Wu et al., 2012) investigated the effect of a multimodal intervention on mood and affect in patients with acute stroke.

The first high quality RCT (Ihle-Hansen et al., 2014) randomized patients to receive a healthy lifestyle promotion program or standard care. Overall mood was measured by the Hospital Anxiety and Depression Scale (HADS) Total score at 1-year post-stroke follow-up. No significant between-group difference was found.

The second high quality RCT (Faulkner et al., 2015) randomized patients to receive an exercise + education program or standard care. Mood and affect were measured by the Profile of Mood States (PMS – Vigor, Confusion, Tension, Anger, Fatigue, Depression) at post-treatment (8 weeks) and follow-up (12 months). A significant between-group difference in change scores from post-treatment to follow-up of one measure of mood and affect (PMS – Fatigue) was found, favoring multimodal intervention vs. standard care.

The fair quality RCT (Wu et al., 2012) randomized patients to receive psychology + physical rehabilitation or no treatment. Mood and affect were measured by the Taita Symptom Checklist (TSCL-90 – Somatization, Obsession, Interpersonal sensitivity, Depression, Anxiety, Hostility, Fear, Paranoia, Mental disease subscores) at day 3 and day 21 of treatment. While there were no significant between-group difference at day 3 of treatment, significant between-group difference was found for most measures of mood and affect (TSCL-90 – Somatization, Obsession, Depression, Anxiety, Hostility, Fear, Mental disease) at day 21, favouring multimodal intervention vs. no treatment.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that a multimodal intervention is not more effective than a comparison intervention (standard care) in improving mood and affect in patients with acute stroke. However, one fair quality RCT found that a multimodal intervention in the form of psychological + comprehensive rehabilitation training is more effective than no treatment in improving some measures of mood and affect in patients with acute stroke.

Physical activity/inactivity
Not effective
1b

One high quality RCT (Faulkner et al., 2015) investigate the effect of a multimodal intervention on physical activity and inactivity in patients with acute stroke. This high quality RCT randomized patients to receive an exercise + education program or standard care. Physical activity/inactivity was measured by the International Physical Activity Questionnaire at post-treatment (8 weeks) and at follow-up (12 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention is not more effective than a comparison intervention (standard care) in improving physical activity/inactivity in patients with acute stroke.

Stroke awareness
Effective
1b

One high quality RCT (Faulkner et al., 2015) investigated the effect of a multimodal intervention on stroke awareness in patients with acute stroke. This high quality RCT randomized patients to receive an exercise + education program or standard care. Stroke awareness was measured by the Stroke Awareness Questionnaire at baseline, post-treatment (8 weeks) and at follow-up (12 months). Significant between-group difference in stroke awareness scores was found from baseline to post-treatment, favoring multimodal intervention vs. usual care. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a multimodal intervention is more effective than a comparison intervention (standard care) in improving stroke awareness in patients with acute stroke, in the short term.

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Acute phase - Neuro-linguistic programming therapy and education

Anxiety
Effective
1b

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on anxiety in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Anxiety was measured by the Hamilton Anxiety Scale at post-treatment (2 weeks) and at follow-up (6 months). Significant between-group difference was found at post-treatment, favoring NLP therapy + health education vs. no treatment. Difference did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in reducing anxiety in patients with acute stroke, in the short term.

Depression
Effective
1b

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on depression in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Depression was measured by the Hamilton-17 Depression Scale at post-treatment (2 weeks) and at follow-up (6 months). Significant between-group difference was found at post-treatment, favoring NLP therapy + health education vs. no treatment. Difference did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in improving depression in patients with acute stroke, in the short term.

Functional independence
Effective
1b

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on functional independence in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Functional independence was measured by the Barthel Index at post-treatment (2 weeks) and at follow-up (6 months). Significant between-group difference was found at both time points, favoring NLP therapy + health education vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in improving functional independence in patients with acute stroke.

Health related quality of life
Effective
1b

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on health-related quality of life in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Health-related quality of life was measured by the Quality of Life Index at post-treatment (2 weeks) and at follow-up (6 months). Significant between-group difference was found at both time points, favoring NLP therapy + health education vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in improving health-related quality of life in patients with acute stroke.

Stroke awareness
Effective
1b

One high quality RCT (Peng et al., 2015) investigated the effect of neuro-linguistic programming (NLP) therapy on stroke awareness in patients with acute stroke. This high quality RCT randomized patients to receive NLP therapy + health education or no treatment; both groups received standard care. Stroke awareness was measured by the Stroke Knowledge Questionnaire at post-treatment (2 weeks). Significant between-group difference was found favoring NLP therapy + health education vs. no treatment.
Note: The Stroke Knowledge Questionnaire was not used at the time of the follow-up.

Conclusion: There is moderate evidence (Level 1b) from one fair quality RCT that neuro-linguistic programming therapy + health education is more effective than no treatment in improving stroke awareness in patients with acute stroke.

Subacute phase - Exercise training

Depression
Conflicting
4

Two high quality RCTs (Lai et al., 2006; Holmgren et al., 2010) investigated the effect of exercise training on depression in patients with subacute stroke.

The first high quality RCT (Lai et al., 2006) randomized patients to receive exercise training or standard care. Depression was measured by the Geriatric Depression Scale 15 (GDS-15 – mean score, score ≥ 6) at post-treatment (3 months) and at follow-up (9 months). Significant between-group difference was found at post-treatment (GDS-15 mean score, score ≥ 6), and at follow-up (GDS-15 score ≥ 6), favoring exercises training vs. standard care.

The second high quality RCT (Holmgren et al., 2010) randomized patients to receive high-intensity functional exercises + group discussions or group discussions alone. Depression was measured by the GDS-15 at post-treatment (5 weeks) and follow-up (3, 6 months). No significant between-group difference was found at any time point.

Conclusion: There is conflicting evidence regarding the effect of exercise training on depression in patients with subacute stroke. While one high quality RCT found that exercise training is more effective than standard care, another high quality RCT found that high-intensity functional exercises + group discussions is not more effective than group discussions alone in improving depression in patients with subacute stroke.
Note:
The differences in the treatment duration (3 months vs. 5 weeks) might justify the differences in findings across these two studies.

Mood and affect
Effective
1b

One high quality RCT (Lai et al., 2006) investigated the effect of exercise training on mood and affect in patients with subacute stroke. This high quality RCT randomized patients to receive exercise training or standard care. Mood and affect were measured by the Stroke Impact Scale (SIS – Emotion score) and the Short-Form-36 (SF-36 – Emotion score) at post-treatment (3 months) and at follow-up (9 months). Significant between-group differences in both measures were found at post-treatment, favoring exercises training vs. standard care. Between-group differences were not maintained at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that exercise training is more effective than a comparison intervention (standard care) in improving mood and affect in patients with subacute stroke, in the short term.

Physical comorbidity
Not effective
1b

One high quality RCT (Lai et al., 2006) investigated the effect of exercise training on physical comorbidity in patients with subacute stroke. This high quality RCT randomized patients to receive exercise training or standard care. Physical comorbidity was measured by the Duke Comorbidity Scale at post-treatment (3 months) and at follow-up (9 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that exercise training is not more effective than a comparison intervention (standard care) in reducing physical comorbidity in patients with subacute stroke.

Quality of life
Not effective
1b

One high quality RCT (Holmgren et al., 2010) investigated the effects of exercise training on quality of life in patients with subacute stroke. This high quality RCT randomized patients to receive high-intensity functional exercises + group discussions or group discussion alone. Quality of life was measured by the Short-Form-36 (SF-36 – Physical Component Scale, Mental Component Scale, Physical functioning, Role functioning physical/emotional, Bodily pain, General health, Vitality, Social functioning, Mental health subscores) at post-treatment (5 weeks) and follow-up (3, 6 months). There were no significant difference at post-treatment. Significant between-group difference was found in two measures of quality of life at 3-month follow-up (SF-36 – Mental Component Scale, Mental health subscore), favoring group discussion alone vs. high-intensity functional exercises + group discussions. Difference did not remain significant at 6-month follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that high-intensity functional exercises + group discussions is not more effective than a comparison intervention (group discussions alone) in improving quality of life in patients with subacute stroke. In fact, high-intensity functional exercises + group discussions was found to be less effective than group discussion alone in improving 2 components of quality of life in patients with subacute stroke.

Social support
Not effective
1b

One high quality RCT (Lai et al., 2006) investigated the effect of exercise training on social support in patients with subacute stroke. This high quality RCT randomized patients to receive exercise training or standard care. Social support was measured by the Pearlin Expressive Social Support Scale at post-treatment (3 months) and at follow-up (9 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that exercise training is not more effective than a comparison intervention (standard care) in improving social support in patients with subacute stroke.

Subacute phase - Speech therapy

Mood and affect
Not effective
2a

One fair quality RCT (Lincoln, Jones & Mulley, 1985) investigated the effect of speech therapy on mood and affect in patients with subacute stroke. This fair quality RCT randomized patients to received speech therapy or no speech therapy; both groups received conventional rehabilitation. Mood and affect were measured by the Mood Rating Scale (Angry-calm, Sad-happy, Afraid-secure, Anxious-relaxed, Depressed-cheerful, Frustrated-contented items) and the Multiple Adjective Checklist (Anxiety, Depression, Hostility subscores) at mid-treatment (12 weeks) and at post-treatment (24 weeks). No significant between-group differences were found on both outcome measures at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that speech therapy is not more effective than no treatment in improving mood and affect in patients with subacute stroke.

Spousal depression
Not effective
2a

One fair quality RCT (Lincoln, Jones & Mulley, 1985) investigated the effect of speech therapy on depression among spouses of patients with subacute stroke. This fair quality RCT randomized patients to received speech therapy or no speech therapy; both groups received conventional rehabilitation. Spousal depression was measured by the Wakefield Depression Inventory at mid-treatment (12 weeks) and at post-treatment (24 weeks). No significant between-group difference was found at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that speech therapy is not more effective than no treatment in improving depression among spouses of patients with subacute stroke.

Spousal mental health
Not effective
2a

One fair quality RCT (Lincoln, Jones & Mulley, 1985) investigated the effect of speech therapy on mental health of spouses of patients with subacute stroke. This fair quality RCT randomized patients to received speech therapy or no speech therapy; both groups received conventional rehabilitation. Spousal mental health was measured by the Goldberg General Health Questionnaire at mid-treatment (12 weeks) and at post-treatment (24 weeks). No significant between-group difference was found at either time point.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that speech therapy is not more effective than no treatment in improving mental health of spouses of patients with subacute stroke.

Chronic phase - Autogenic relaxation

Anxiety
Effective
1b

One high quality RCT (Golding et al., 2016) and a follow-up report (Golding et al., 2017a) investigated the effect of an autogenic relaxation program on anxiety in patients with chronic stroke. This high quality RCT randomized patients to receive an autogenic relaxation program or no treatment (waiting list). Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety subscale) at baseline, at post-treatment (1 month), and follow-up (2 and 3 months, and 12 months). Significant between-group difference was found at post-treatment and follow-up (2 and 3 months), favoring the autogenic relaxation program vs. no treatment. Between-group analyses were not conducted at 12-month follow-up. However, both groups demonstrated significantly reduced anxiety from baseline to 12-month follow-up, at which timepoint all participants had received the intervention.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an autogenic relaxation program is more effective than no treatment in reducing anxiety in patients with chronic stroke.

Depression
Not effective
1b

One high quality RCT (Golding et al., 2017b) investigated the effect of an autogenic relaxation program on anxiety in patients with chronic stroke. This high quality RCT randomized patients to receive an autogenic relaxation program or no treatment (waiting list). Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression subscale) at post-treatment (1 month) and follow-up (2 and 3 months, and 12 months). No significant between-group difference was found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an autogenic relaxation program is not more effective than no treatment in improving depression in patients with chronic stroke.

Chronic phase - Forest therapy

Anxiety
Effective
2a

One fair quality RCT (Chun et al., 2017) investigated the effect of forest therapy on anxiety in patients with chronic stroke. This fair quality RCT randomized patients to receive forest therapy or urban therapy in group format. Anxiety was measured by the Spielberger State-Trait Anxiety Inventory at post-treatment (4 days). Significant between-group difference was found favoring forest therapy vs. urban therapy.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that forest therapy is more effective than a comparison intervention (urban therapy) in reducing anxiety in patients with chronic stroke.

Depression
Effective
2a

One fair quality RCT (Chun et al., 2017) investigated the effect of forest therapy on depression in patients with chronic stroke. This fair quality RCT randomized patients to receive forest therapy or urban therapy in group format. Depression was measured by the Beck Depression Inventory and the Hamilton Depression Rating Scale at post-treatment (4 days). Significant between-group differences were found at post-treatment on both outcome measures of depression, favoring forest therapy vs. urban therapy.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that forest therapy is more effective than a comparison intervention (urban therapy) in improving depression in patients with chronic stroke.

Chronic phase - Yoga

Anxiety
Not effective
1a

Two high quality RCTs (Chan, Immink & Hillier, 2012; Immink et al., 2014) investigated the effect of yoga on anxiety in patients with chronic stroke.

The first high quality RCT (Chan, Immink & Hillier, 2012) randomized patients to receive yoga + exercises or exercises alone. Anxiety was measured by the State-Trait Anxiety Inventory (STAI – State anxiety, Trait anxiety scores) at post-treatment (6 weeks). No significant between-group difference was found.

The second high quality RCT (Immink et al., 2014) randomized patients to receive yoga or no treatment (waiting list). Anxiety was measured by the STAI (State anxiety, Trait anxiety scores) at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that yoga is not more effective than comparison intervention (exercises alone, no treatment) in reducing anxiety in patients with chronic stroke.

Balance
Not effective
1b

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on balance in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Balance was measured by the Berg Balance Scale at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that yoga is not more effective than no treatment in improving balance in patients with chronic stroke.

Depression
Not effective
1a

Two high quality RCTs (Chan, Immink & Hillier, 2012; Immink et al., 2014) investigated the effect of yoga on depression in patients with chronic stroke.

The first high quality RCT (Chan, Immink & Hillier, 2012) randomized patients to receive yoga + exercises or exercises alone. Depression was measured by the Geriatric Depression Scale – Short Form 15 (GDS-15) at post-treatment (6 weeks). No significant between-group difference was found.

The second high quality RCT (Immink et al., 2014) randomized patients to receive yoga or no treatment (waiting list). Depression was measured by the GDS-15 at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that yoga is not more effective than comparison interventions (exercises alone, no treatment) in improving depression in patients with chronic stroke.

Mobility
Not effective
1b

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on mobility in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Mobility was measured by the 2-Minute Walking Distance test at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that yoga is not more effective than no treatment in improving mobility in patients with chronic stroke.

Motor function
Not effective
1b

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on motor function in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Motor function was measured by the Motor Assessment Scale at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that yoga is not more effective than no treatment in improving motor function in patients with chronic stroke.

Stroke outcomes
Not effective
1b

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on stroke outcomes in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Stroke outcomes were measured by the Stroke Impact Scale (SIS – Physical, Emotion, Memory, Communication, Social participation, Stroke recovery subscores) at post-treatment (10 weeks). Significant between-group difference was found for only one stroke outcome (SIS – Memory), favoring yoga vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that yoga is not more effective than no treatment in improving stroke outcomes in patients with chronic stroke.

Walking speed
Not effective
1b

One high quality RCT (Immink et al., 2014) investigated the effect of yoga on walking speed in patients with chronic stroke. This high quality RCT randomized patients to receive yoga or no treatment (waiting list). Walking speed was measured by the Comfortable Gait Speed test at post-treatment (10 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that yoga is not more effective than no treatment in improving walking speed in patients with chronic stroke.

Phase not specific to one period - Art therapy

Anxiety
Not effective
1b

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on anxiety in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety score) at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that art therapy is not more effective than no art therapy (physical therapy alone) in reducing anxiety in patients with stroke.

Cognition
Not effective
1b

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on cognition in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. Cognition was measured by the Abbreviated Mental Test at post-treatment (4 weeks). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that art therapy is not more effective than no art therapy (physical therapy alone) in improving cognition in patients with stroke.

Depression
Effective
1b

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on depression in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression score) at post-treatment (4 weeks). Significant between-group difference was found favoring art therapy vs. no art therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that art therapy is more effective than no art therapy (physical therapy alone) in improving depression in patients with stroke.

Functional independence
Effective
1b

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on functional independence in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. Functional independence was measured by the Modified Barthel Index at post-treatment (4 weeks). Significant between-group difference was found favoring art therapy vs. no art therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that art therapy is more effective than no art therapy (physical therapy alone) in improving functional independence in patients with stroke.

Health related quality of life
Effective
1b

One high quality RCT (Kongkasuwan et al., 2016) investigated the effect of art therapy on health-related quality of life (HRQoL) in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive art therapy or no art therapy; both groups received physical therapy. HRQoL was measured by the Pictorial Thai Quality of Life Questionnaire at post-treatment (4 weeks). Significant between-group difference was found favoring art therapy vs. no art therapy.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that art therapy is more effective than no art therapy (physical therapy alone) in improving health-related quality of life in patients with stroke.

Phase not specific to one period - Cognitive behavioral therapy

Anger
Effective
2a

One fair quality RCT (Chang et al., 2011) investigated the effect of cognitive behavioral therapy (CBT) on anger in patients with stroke. This fair quality RCT randomized patients with acute / subacute / chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional therapy. Anger was measured by the State-Trait Anger Expression Inventory (STAXI – State anger, Hostility, Anger-in, Anger-out, Anger control items) at baseline and at post-treatment (1 month). Significant between-group difference in anger (STAXI – State anger, Anger-out, Anger control) change scores from baseline to post-treatment was found in favor of CBT vs. no CBT. In contrast, significant between-group difference in anger (STAXI – Anger-in) change scores from baseline to post-treatment was found in favor of no CBT vs. CBT.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that cognitive behavioral therapy is more effective than no CBT in improving some aspects of anger in patients with stroke.

Anxiety
Not effective
1a

Two high quality RCTs (Hoffmann et al., 2015; Kootker et al., 2017) and one fair quality RCT (Chang et al., 2011) investigated the effect of cognitive behavioral therapy (CBT) on anxiety in patients with stroke.

The first high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety score) and the State-Trait Anxiety Inventory (STAI – Trait anxiety, State anxiety scores) at post-treatment (8 sessions) and follow-up (3 months). No significant between-group differences were found on both outcome measures at either time point.

The second high quality RCT (Kootker et al., 2017) randomized patients with subacute/chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation/communication strategies) or computerized cognitive therapy. Anxiety was measured by the HADS (Anxiety score) at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group difference was found at any time point.

The fair quality RCT (Chang et al., 2011) randomized patients with acute/subacute/chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional rehabilitation. Anxiety was measured by the Hamilton Anxiety Rating Scale at post-treatment (1 month). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs and one fair quality RCT that cognitive behavioral therapy is not more effective than a comparison intervention (self-management intervention, computerized cognitive therapy, no treatment) in reducing anxiety in patients with stroke.

Caregiver burden
Not effective
1b

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on burden among caregivers of patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Caregivers’ burden was measured by the Caregiver Strain Index at follow-up (6 months). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than no CBT in improving caregiver burden following stroke.

Coping
Not effective
1b

One high quality RCT (Kootker et al., 2017) investigated the effect of cognitive behavioral therapy (CBT) on coping in patients with stroke. This high quality RCT randomized patients with subacute / chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation / communication strategies) or computerized cognitive therapy. Coping was measured by the Utrecht Proactive Coping Competence Life Scale at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group difference was found at any time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than a comparison intervention (computerized cognitive training) in improving coping in patients with stroke.

Depression
Not effective
1a

Four high quality RCTs (Lincoln & Flannaghan, 2003; Thomas et al., 2012; Hoffmann et al., 2015; Kootker et al., 2017) and two fair quality RCTs (Chang et al., 2011; Alexopoulos et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on depression in patients with stroke.

The first high quality RCT (Lincoln & Flannaghan, 2003) randomized patients with subacute / chronic stroke to receive CBT, attention placebo, or no treatment. Depression was measured by the Beck Depression Inventory and the Wakefield Self-Assessment of Depression Inventory at post-treatment (3 months) and follow-up (6 months). No significant between-group differences were found on both outcome measures at either time point.

The second high quality RCT (Thomas et al., 2012) randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Depression was measured by the Stroke Aphasia Depression Questionnaire 21-item hospital version at post-treatment (3 months) and follow-up (6 months). No significant between-group difference was found at post-treatment, however a significant between-group difference in depression was found at follow-up, favoring CBT vs. no CBT.

The third high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression score) and the Montgomery and Asberg Depression Rating Scale at post-treatment (8 sessions) and follow-up (3 months). A significant between-group difference in one measure of depression (HADS – Depression) was found at post-treatment, favoring CBT vs. no treatment. Differences did not remain significant at follow-up. No other between-group differences were found.

The fourth high quality RCT (Kootker et al., 2017) randomized patients with subacute/chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation/communication strategies) or computerized cognitive therapy. Depression was measured by the HADS (Depression score) and the Post-Stroke Depression Rating Scale at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group differences were found on both outcome measures at any time point.

The first fair quality RCT (Chang et al., 2011) randomized patients with acute / subacute / chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional rehabilitation. Depression was measured by the Hamilton Depression Rating Scale (HDRS) at baseline and at post-treatment (1 month). Significant between-group difference in depression change scores from baseline to post-treatment was found, favoring CBT vs. no CBT.

The second fair quality RCT (Alexopoulos et al., 2012) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (Ecosystem Focused Therapy: education and behavioral training, goal setting) or education on stroke and depression. Depression was measured by the HDRS at post-treatment (3 months). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs and one fair quality RCT that cognitive behavioral therapy is not more effective than comparison interventions (attention placebo, no treatment, self-management intervention, computerized cognitive therapy, education on stroke and depression) in improving depression in patients with stroke.
Note:
However, one high quality RCT saw significant between-group differences in one measure of depression immediately following CBT versus no treatment; a fair quality RCT also found differences in depression in favour of CBT vs. no CBT. In addition, one of the high quality RCTs that saw no difference between CBT and no CBT immediately post-treatment found CBT to be more effective than no CBT at 6-month follow-up.

Disability
Not effective
1b

One high quality RCT (Lincoln & Flannaghan, 2003) and one fair quality RCT (Alexopoulos et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on disability in patients with stroke.

The high quality RCT (Lincoln & Flannaghan, 2003) randomized patients with subacute / chronic stroke to receive CBT, attention placebo, or no treatment. Disability was measured by the London Handicap Scale at post-treatment (3 months) and follow-up (6 months). No significant between-group differences were found at any time point.

The fair quality RCT (Alexopoulos et al., 2012) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (Ecosystem Focused Therapy: education and behavioral training, goal setting) or education on stroke and depression. Disability was measured by the World Health Organization Disability Assessment Schedule II at post-treatment (3 months). Significant between-group difference was found favoring CBT vs. education.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than comparison interventions (attention placebo, no treatment) in improving disability in patients with stroke.
Note:
However, one fair quality RCT found that CBT was more effective than a comparison intervention (education on stroke and depression) in improving disability in patients with stroke.

Functional independence
Not effective
1b

One high quality RCT (Hoffmann et al., 2015) and one fair quality RCT (Chang et al., 2011) investigated the effect of cognitive behavioral therapy (CBT) on functional independence in patients with stroke.

The high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Functional independence was measured by the modified Barthel Index (mBI) at post-treatment (8 sessions) and follow-up (3 months). No significant between-group differences were found at either time point.

The fair quality RCT (Chang et al., 2011) randomized patients with acute/subacute/chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional rehabilitation. Functional independence was measured by the BI at baseline and at post-treatment (1 month). Significant between-group difference in functional independence change scores from baseline to post-treatment was found, favoring CBT vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than comparison interventions (self-management intervention, no treatment) in improving functional independence in patients with stroke.
Note:
However, one fair quality RCT found that CBT is more effective than no CBT in improving functional independence in patients with stroke.

Health related quality of life
Not effective
1a

Two high quality RCTs (Hoffmann et al., 2015; Kootker et al., 2017) and one fair quality RCT (Chang et al., 2011) investigated the effect of cognitive behavioral therapy (CBT) on health-related quality of life (HRQoL) in patients with stroke.

The first high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. HRQoL was measured by the Stroke and Aphasia Quality of Life Scale (SAQoL – General, Psychosocial, Physical, Communication subscores) at post-treatment (8 sessions) and follow-up (3 months). No significant between-group differences were found at either time point.

The second high quality RCT (Kootker et al., 2017) randomized patients with subacute/chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation/communication strategies) or computerized cognitive therapy. HRQoL was measured by the Life Satisfaction Questionnaire and the Stroke Specific Quality of Life (SSQoL) Scale at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group differences were found on both outcome measures at any time point.

The fair quality RCT (Chang et al., 2011) randomized patients with acute/subacute/chronic stroke to receive CBT (education and behavioral training) or no CBT; both groups received conventional rehabilitation. HRQoL was measured by the SSQoL at baseline and post-treatment (1 month). Significant between-group difference in SSQoL change scores from baseline to post-treatment was found, favoring CBT vs. no treatment.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that cognitive behavioral therapy is not more effective than comparison interventions (self-management intervention, no treatment, computerized cognitive therapy) in improving health-related quality of life in patients with stroke.
Note:
However, one fair quality RCT found that CBT was more effective than no CBT in improving health-related quality of life in patients with stroke.

Instrumental activities of daily living
Not effective
1a

Two high quality RCTs (Lincoln & Flannaghan, 2003; Hoffmann et al., 2015) investigated the effect of cognitive behavioral therapy (CBT) on instrumental activities of daily living (IADLs) in patients with stroke.

The first high quality RCT (Lincoln & Flannaghan, 2003) randomized patients with subacute / chronic stroke to receive CBT, attention placebo, or no treatment. IADLs were measured by the Extended Activities of Daily Living Scale at post-treatment (3 months) and follow-up (6 months). No significant between-group differences were found at either time point.

The second high quality RCT (Hoffmann et al., 2015) randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. IADLs were measured by the Nottingham Extended Activities of Daily Living Scale at post-treatment (8 sessions) and follow-up (3 months). No significant between-group differences were found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that cognitive behavioral therapy is not more effective than comparison interventions (attention placebo, self-management intervention, no treatment) in improving instrumental activities of daily living in patients with stroke.

Leisure
Not effective
1b

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on leisure in patients with stroke. This high quality RCT randomized patients with subacute / chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Leisure was measured by the Nottingham Leisure Questionnaire at post-treatment (3 months) and follow-up (6 months). While no significant between-group difference was found at post-treatment, a significant between-group difference in leisure was found at follow-up, favoring CBT vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than no CBT in improving leisure in patients with stroke.

Mood and affect
Effective
1b

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on mood and affect in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Mood and affect was measured by the Visual Analogue Mood Scale (Sad item) at post-treatment (3 months) and follow-up (6 months). A significant between-group difference was found at both time points, favoring CBT vs. no CBT.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is more effective than no CBT in improving mood and affect in patients with stroke.

Satisfaction with care
Not effective
1b

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on satisfaction with care in patients with stroke and their caregivers. This high quality RCT randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Patients’ and carers’ satisfaction with care was measured by the Visual Analogue Satisfaction with Care Rating at follow-up (6 months). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than no CBT in improving satisfaction with care in patients with stroke.

Self-efficacy
Not effective
1b

One high quality RCT (Hoffmann et al., 2015) investigated the effect of cognitive behavioral therapy (CBT) on self-efficacy in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Self-efficacy was measured by the Stroke Self-Efficacy Questionnaire at post-treatment (8 sessions) and follow-up (3 months). No significant between-group differences were found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than comparison interventions (self-management intervention, no treatment) in improving self-efficacy in patients with stroke.

Self-esteem
Effective
1b

One high quality RCT (Thomas et al., 2012) investigated the effect of cognitive behavioral therapy (CBT) on self-esteem in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke and low mood to receive CBT or no CBT; both groups received usual care. Self-esteem was measured by the Visual Analogue Self-Esteem Scale at post-treatment (3 months) and follow-up (6 months). A significant between-group difference in self-esteem was found at both time points, favoring CBT vs. no CBT.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is more effective than no CBT in improving self-esteem in patients with stroke.

Social participation
Not effective
1b

One high quality RCT (Kootker et al., 2017) investigated the effect of cognitive behavioral therapy (CBT) on social participation in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive CBT (goal-setting, meaningful activities, relaxation/communication strategies) or computerized cognitive therapy. Social participation was measured by the Utrecht Scale for Evaluation of Rehabilitation (Participation subscale) at post-treatment (4 months) and at follow-up (8 and 12 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is not more effective than a comparison intervention (computerized cognitive training) in improving social participation in patients with stroke.

Stroke knowledge
Effective
1b

One high quality RCT (Hoffmann et al., 2015) investigated the effect of cognitive behavioral therapy (CBT) on stroke knowledge in patients with stroke. This high quality RCT randomized patients with stroke (stage of stroke recovery not specified) to receive CBT (cognitive and behavioral coping-skills exercises), self-management intervention or no treatment. Stroke knowledge was measured by the Stroke Knowledge Questionnaire at post-treatment (8 sessions) and follow-up (3 months). Significant between-group differences were found for stroke knowledge at post-treatment, favoring CBT vs. no treatment. These differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that cognitive behavioral therapy is more effective than no treatment in improving self-efficacy in patients with stroke.
Note:
CBT was not more effective than a comparison intervention (self-management intervention) in improving stroke knowledge.

Phase not specific to one period - Discharge care coordination

Adherence to self-management practices
Effective
2a

One fair quality RCT (Clairborne, 2006) investigated the effect of discharge care coordination on adherence to self-management practices in patients with stroke. This fair quality RCT randomized patients with acute/subacute stroke to receive care coordination at discharge or no treatment; both group received standard follow-up care. Adherence to self-management practices was measured by the number of incidences in which patients did not follow through with self-management practices (medication regimen, medical appointments, dietary requirements, home exercise program, stress reduction, and other individualized recommendations) at follow-up (3 months post-discharge). Significant between-group difference was found favoring care coordination vs. no treatment.

Conclusion: There is limited evidence (Level 2a) from one fair quality RCT that discharge care coordination is more effective than no treatment in improving adherence to self-management practices in patients with stroke.

Caregiver burden
Effective
1b

One high quality RCT (Burton & Gibbon, 2005) investigated the effect of discharge care coordination on burden among caregivers of individuals with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. Caregivers’ burden was measured by the Caregiver Strain Index at baseline, at post-treatment (3 months post-stroke), and at follow-up (12 months post-stroke). Significant between-group difference was found at post-treatment, favoring discharge education and support vs. usual care. In addition, there were significant between-group difference in caregiver burden change scores from baseline to follow-up, favoring discharge education and support vs. usual care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that discharge support and education from a stroke nurse is more effective than a comparison intervention (usual discharge care) in improving caregiver’s burden among caregivers of patient with stroke.

Depression
Conflicting
4

Two high quality RCTs (Burton & Gibbon, 2005; Graven et al., 2016) and one fair quality RCT (Clairborne, 2006) investigated the effect of discharge care coordination on depression among patients with stroke.

The first high quality RCT (Burton & Gibbon, 2005) randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. Depression was measured by the Beck Depression Inventory at post-treatment (3 months post-stroke) and at follow-up (12 months post-stroke). No significant between-group difference was found at either time point.

The high quality RCT (Graven et al., 2016) randomized patients with acute/subacute stroke to receive multimodal discharge management (liaison with services, education, follow-up) or standard discharge care. Depression was measured by the Geriatric Depression Scale (GDS-15) at follow-up (1 year post-stroke). Significant between-group difference was found favoring multimodal discharge management vs. standard discharge care.

The fair quality RCT (Clairborne, 2006) randomized patients with acute/subacute stroke to receive care coordination at discharge or no treatment; both group received standard follow-up care. Depression was measured by the GDS-15 at follow-up (3 months post-discharge). Significant between-group difference was found at follow-up, favoring care coordination vs. no treatment.

Conclusion: There is conflicting evidence (Level 4) on the effect of discharge care coordination in improving depression in patients with stroke. While one high quality RCT found that discharge support and education from a stroke nurse is not more effective than usual discharge care; another high quality RCT and a fair quality RCT found that discharge care coordination is more effective than usual discharge care in improving depression in patients with stroke.
Note:
Differences in outcomes measures used could explain the differences in found treatment effects across these studies.

Functional independence
Effective
1b

One high quality RCT (Burton & Gibbon, 2005) investigated the effect of discharge care coordination on functional independence in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. Functional independence was measured by the Barthel Index at post-treatment (3 months post-stroke) and at follow-up (12 months post-stroke). While no significant between-group difference was found at post-treatment, there was a significant between-group difference in change scores from 3 to 12 months, favoring discharge support vs. usual discharge care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that discharge support and education from a stroke nurse is more effective than a comparison intervention (usual discharge care) in improving functional independence in patients with stroke.

Health related quality of life
Effective
1b

One high quality RCT (Burton & Gibbon, 2005) and one fair quality RCT (Clairborne, 2006) investigated the effect of discharge care coordination on health-related quality of life (HRQoL) in patients with stroke.

The high quality RCT (Burton & Gibbon, 2005) randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. HRQoL was measured by the Nottingham Health Profile (NHP – Total score, Energy, Emotional reaction, Physical mobility, Pain, Social isolation, Sleep subscores) at post-treatment (3 months post-stroke) and at follow-up (12 months post-stroke). Significant between-group difference was found at post-treatment (NHP – Emotional reaction, Pain, Social isolation), and at follow-up (NHP – Emotional reaction, Social isolation, Total score), favoring discharge support and education vs. usual care.

The fair quality RCT (Clairborne, 2006) randomized patients with acute/subacute stroke to receive care coordination at discharge or no treatment; both group received standard follow-up care. HRQoL was measured by the Short-Form 36 (SF-36 – Physical Component Summary; SF-36 – Mental Component Summary) at follow-up (3 months post-discharge). Significant between-group difference was found (SF-36 – Mental Component Summary) favoring care coordination vs. no treatment.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT and one fair quality RCT that discharge care coordination is more effective than comparison interventions (usual discharge care, no treatment) in improving aspects of health-related quality of life in patients with stroke.

Instrumental activities of daily living
Not effective
1b

One high quality RCT (Burton & Gibbon, 2005) investigated the effect of discharge care coordination on instrumental activities of daily living (IADLs) in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive discharge support and education from a stroke nurse or usual discharge care. IADLs were measured by the Frenchay Activities Index at post-treatment (3 months post-stroke) and at follow-up (12 months post-stroke). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that continued discharge support from a stroke nurse is not more effective than a comparison intervention (usual discharge care) in improving instrumental activities of daily living in patients with stroke.

Phase not specific to one period - Environmental enrichment inpatient program

Cognition
Not effective
1b

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on cognition in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Cognition was measured by the Montreal Cognitive Assessment at post-treatment (discharge from the inpatient ward, range of duration: 9-12 days). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an environmental enrichment inpatient program is not more effective than a comparison intervention (usual ward activity) in improving cognition in patients with stroke.

Emotional state
Effective
1b

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on emotional state of patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Emotional state was measured by the Depression Anxiety Stress Scale (DASS – Total, Depression, Anxiety, Stress subscores) at post-treatment (discharge from the inpatient ward, range 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). Significant between-group difference was seen for all measures of negative emotional state (DASS – Total, Depression, Anxiety, Stress subscores) at post-treatment, favoring EE inpatient program vs. usual ward activity. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an environmental enrichment inpatient program is more effective than a comparison intervention (usual ward activity) in improving negative emotional state of patients with stroke, in the short term.

Functional independence
Effective
1b

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on functional independence in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Functional independence was measured by the Functional Independence Measure (FIM – Motor total, Self-care, Sphincter, Mobility, Locomotion, Cognition total, Communication, Psychosocial, Social cognition subscores) at post-treatment (discharge from the inpatient ward, range of duration: 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). Significant between-group difference was found for three measures of functional independence (FIM – Motor total, Self-care, Mobility subscores) at post-treatment, favoring EE inpatient program vs. usual ward activity. Difference did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an environmental enrichment inpatient program is more effective than a comparison intervention (usual ward activity) in improving some aspects of functional independence in patients with stroke, in the short term.

Health related beliefs
Not effective
1b

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on health-related beliefs in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Health-related beliefs were measured by the Multidimensional Health Locus of Control Scale (MHLC – Internal, Chance, Doctors, Other people items) at post-treatment (discharge from the inpatient ward, range 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). A significant between-group difference in one item (MHLC – Internal) was found at post-treatment, favoring EE inpatient program vs. usual ward activity. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an environmental enrichment inpatient program is not more effective than a comparison intervention (usual ward activity) in improving health-related beliefs in patients with stroke.

Health related quality of life
Not effective
1b

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on health-related quality of life (HRQoL) in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. HRQoL was measured by the EQ-5D (Mobility, Self-care, Daily activity, Pain/discomfort, Anxiety/depression, Index value, Overall health scores) at post-treatment (discharge from the inpatient ward, range 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). A significant between-group difference in one measure (EQ-5D – Index value) was seen at post-treatment, favoring EE inpatient program vs. usual ward activity. At follow-up there was a significant between-group difference in overall health-related quality of life (EQ-5D – Overall health), favoring EE inpatient program vs. usual ward activity.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an environmental enrichment inpatient program is not more effective than a comparison intervention (usual ward activity) in improving health-related quality of life in patients with stroke.

Self-esteem
Not effective
1b

One high quality RCT (Khan et al., 2016) investigated the effect of environmental enrichment (EE) on self-esteem in patients with stroke. This high quality RCT randomized patients with neurological conditions (n=53 with acute/subacute/chronic stroke) to receive an EE inpatient program or usual ward activity. Self-esteem was measured by the Rosenberg Self-Esteem Scale at post-treatment (discharge from the inpatient ward, range 9-12 days) and at follow-up (3 months post-discharge from the inpatient ward). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that an environmental enrichment inpatient program is not more effective than a comparison intervention (usual ward activity) in improving self-esteem in patients with stroke.

Phase not specific to one period - Relaxation

Anxiety
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on anxiety in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS – Anxiety) at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in reducing anxiety in patients with stroke.

Balance
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on balance in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Balance was measured by the Functional Reach Test at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving balance in patients with stroke.

Depression
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on depression in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Depression was measured by the Hospital Anxiety and Depression Scale (HADS – Depression) at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving depression in patients with stroke.

Functional independence
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on functional independence in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Functional independence was measured by the Functional Independence Measure at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving functional independence in patients with stroke.

Instrumental activities of daily living
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on instrumental activities of daily living (IADLs) in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. IADLs were measured by the Nottingham Extended Activities of Daily Living Scale at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving instrumental activities of daily living in patients with stroke.

Health related quality of life
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on health-related quality of life (HRQoL) in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. HRQoL was measured by the Short-Form 36 (SF-36 – Physical functioning, Role physical, General health, Vitality, Mental health scores) at post-treatment (3 months) and follow-up (7 months). A significant between-group difference in one measure of HRQoL (SF-36 – Role physical) was found at both time points, favoring exercise vs. relaxation.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving health-related quality of life in patients with stroke.
Note:
In fact, exercise training was found to be more effective than relaxation in improving quality of life relating to physical role function.

Mobility
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on mobility in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Mobility was measured by the Rivermead Mobility Index and the Timed Up and Go Test (TUG) at post-treatment (3 months) and follow-up (7 months). A significant between-group difference in one measure of mobility (TUG) was found at post-treatment, favoring exercise vs. relaxation. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving mobility in patients with stroke.
Note:
In fact, exercise training was found to be more effective than relaxation in improving one measure of mobility.

Power/strength (lower extremity)
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on lower extremity power/strength in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Lower extremity power was measured by the Nottingham Power Rig (NPR – Affected extensors, Non-affected extensors, W/kg) and lower extremity strength was measured by the Sit-to-Stand timed test at post-treatment (3 months) and follow-up (7 months). No significant between-group differences were found at either time point for either measure.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving lower extremity power/strength in patients with stroke.

Walking economy
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on walking economy in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive relaxation or exercise training. Walking economy (oxygen uptake, ml/kg per meter) was measured by a portable breath-by-breath metabolic measurement system at post-treatment (3 months) and follow-up (7 months). A significant between-group difference was found at post-treatment, favoring exercise training vs. relaxation. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving walking economy in patients with stroke.
Note:
In fact, exercise training was found to be more effective than relaxation in improving walking economy.

Walking speed
Not effective
1b

One high quality RCT (Mead et al., 2007) investigated the effect of relaxation on walking speed in patients with stroke. This high quality RCT randomized patients with subacute / chronic stroke to receive relaxation or exercise training. Walking speed (m/s) was measured by walking a 17-m circuit at comfortable speed at post-treatment (3 months) and follow-up (7 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that relaxation is not more effective than a comparison intervention (exercise training) in improving walking speed in patients with stroke.

Phase not specific to one period - Stroke psychosocial education programs

Caregivers' burden
Not effective
1b

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on burden among caregivers of individuals with stroke. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Caregivers’ burden was measured by the Zarit Burden Inventory at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that home-based psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in improving caregivers’ burden among caregivers of patients with stroke.

Caregiver's coping
Not effective
1b

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on coping among caregivers of individuals with stroke. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Caregivers’ coping was measured by the Family Crisis Oriented Personal Evaluation Scales (F-COPES – Mobilising family support, Acquiring social support, Reframing, Seeking spiritual support, Passive appraisal subscores) at post-treatment (6 months) and follow-up (12 months). Significant between-group difference in two measures of coping (F-COPES – Mobilising family support, Acquiring social support) was found at follow-up only, favoring home-based psychosocial education + mailed information vs. mailed information alone.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in improving coping among caregivers of individuals who have had a stroke.

Caregivers' preparedness
Not effective
1b

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on preparedness among caregivers of individuals with stroke. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Caregivers’ preparedness was measured by the 4-Item Caregiver Preparedness Scale at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in improving preparedness among caregivers of individuals who have had a stroke.

Caregivers' social support
Not effective
1a

Two high quality RCTs (Smith et al., 2012; Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on social support among caregivers of individuals with stroke.

The first high quality RCT (Smith et al., 2012) randomized patients with stroke (stage of stroke recovery unspecified) and their caregivers to receive a web-based psychoeducation program or no treatment. Caregiver’s social support was measured by the 11-item Medical Outcome Study (MOS) Social Support Survey at post-treatment (9 weeks) and follow-up (1 month). No significant between-group difference was found at either time point.

The second high quality RCT (Ostwald et al., 2014) randomized patients with acute / subacute / chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Caregivers’ social support was measured by the MOS Social Support Survey at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that a stroke psychosocial education program is not more effective than comparison interventions (no treatment, mailed information alone) in improving social support among caregivers of individuals who have had a stroke.

Depression
Not effective
1a

Three high quality RCTs (Smith et al., 2012; Ostwald et al., 2014; Saal et al., 2015) investigated the effect of a stroke psychosocial education program on depression in patients with stroke.

The first high quality RCT (Smith et al., 2012) randomized patients with stroke (stage of stroke recovery unspecified) and their caregivers to receive a web-based psychoeducation program or no treatment. Depression among patients and caregivers was measured by the Patient Health Questionnaire – 9 (PHQ) and the 20-item Center for Epidemiological Studies Depression (CESD) at post-treatment (9 weeks) and follow-up (1 month). There were no significant differences in depression among patients at either time point. Significant between-group differences in caregivers’ depression (CESD) were found at both time points, favoring the web-based psychoeducation program vs. no program.

The second high quality RCT (Ostwald et al., 2014) randomized patients with acute / subacute / chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Depression among patients and caregivers was measured by the Brief Geriatric Depression Scale at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point for patients or caregivers.

The third high quality RCT (Saal et al., 2015) randomized patients with acute/subacute stroke to receive stroke education + support (home visits, mailed information, educational sessions) or mailed information alone (2 brochures). Depression was measured by the Geriatric Depression Scale at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is strong evidence (Level 1a) from three high quality RCTs that a stroke psychosocial education program is not more effective than comparison interventions (no treatment, mailed information alone) in improving depression in patients with stroke.
Note:
Results regarding depression among caregivers was conflicting (level 4). One high quality RCT reported significant differences on one measure of depression (CESD) among caregivers in favour of web-based psychoeducational intervention vs. no treatment, whereas a second high quality RCT found no difference in caregivers’ depression following home-based psychosocial education + mailed information vs. mailed information alone.

Functional independence
Effective
1b

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on functional independence in patients with stroke. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Functional independence was measured by the Functional Independence Measure (FIM – Motor, Cognitive subtotals) at post-treatment (6 months) and at follow-up (12 months). Significant between-group difference was found at post-treatment (FIM – Cognitive), favoring psychosocial education + mailed information vs. mailed information alone. Differences did not remain significant at follow-up.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that home-based psychosocial education + mailed information is more effective than comparison interventions (mailed information alone) in improving functional independence in patients with stroke.

Health related quality of life
Conflicting
4

Two high quality RCTs (Ostwald et al., 2014; Saal et al., 2015) investigated the effect of a stroke psychosocial education program on health-related quality of life (HRQoL) in patients with stroke.

The first high quality RCT (Ostwald et al., 2014) randomized patients with acute / subacute / chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. HRQoL of patients and caregivers was measured by the Medical Outcomes Study Short-Form Survey (SF-36) at post-treatment (6 months) and at follow-up (12 months). Significant between-group difference in HRQoL of patients and caregivers was found at post-treatment, favoring psychosocial education + mailed information vs. mailed intervention alone. Difference did not remain significant at follow-up.

The second high quality RCT (Saal et al., 2015) randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). HRQoL was measured by the World Health Organization Quality of Life Short Version at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is conflicting evidence (Level 4) regarding the effect of psychosocial education programs on health-related quality of life following stroke. One high quality RCT reported that psychosocial education + mailed information was more effective than mailed information alone in improving health-related quality of life of patients and carers, whereas a second high quality RCT found no significant difference between stroke education + support vs. mailed information in improving health-related quality of life of patients following stroke. Differences in content, administration and duration of services, and/or outcome measures used to assess health-related quality of life may account for differences in findings.

Health services usage
Not effective
1b

One high quality RCT (Saal et al., 2015) investigated the effect of a stroke psychosocial education program on health services usage in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). Health services usage (use frequency of health services) was measured at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a stroke education + support is not more effective than a comparison intervention (mailed information alone) in improving patients’ use of health services after stroke.

Mastery
Not effective
1b

One high quality RCTs (Smith et al., 2012) investigated the effect of a stroke psychosocial education program on mastery among patients with stroke and their caregivers. This high quality RCT randomized patients with stroke (stage of stroke recovery unspecified) and their caregivers to receive a web-based psychoeducation program or no treatment. Mastery among patients and caregivers was measured by the Pearlin & Schooler Mastery Scale at post-treatment (9 weeks) and follow-up (1 month). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a web-based psychoeducation intervention is not more effective than a comparison intervention (no treatment) in improving mastery in patients with stroke or their caregivers.

Perceived stress
Not effective
1b

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on perceived stress among patients with stroke and their caregivers. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Perceived stress among patients and caregivers was measured by the 10-item Perceived Stress Scale at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found for patients or caregivers at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in reducing perceived stress among patients with stroke and their caregivers.

Psychological symptoms
Not effective
1b

One high quality RCT (Saal et al., 2015) investigated the effect of a stroke psychosocial education program on psychological symptoms in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). Psychological symptoms were measured by the Symptom Checklist 90 Revised (Somatization subscale) at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that stroke education and support is not more effective than a comparison intervention (mailed information) in improving psychological symptoms in patients with stroke.

Quality of caregiving relationship
Not effective
1b

One high quality RCT (Ostwald et al., 2014) investigated the effect of a stroke psychosocial education program on the quality of caregiving relationships between patients with stroke and their caregivers. This high quality RCT randomized patients with acute/subacute/chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Quality of caregiving relationships between patients and caregivers was measured by the Mutuality Scale at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point among patients or caregivers.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that psychosocial education + mailed information is not more effective than a comparison intervention (mailed information alone) in improving the quality of caregiving relationship in patients with stroke and their caregivers.

Self-esteem
Not effective
1b

One high quality RCTs (Smith et al., 2012) investigated the effect of a stroke psychosocial education program on self-esteem among patients with stroke and their caregivers. This high quality RCT randomized patients with stroke (stage of stroke recovery unspecified) and their caregivers to receive a web-based psychoeducation program or no treatment. Patients’ and caregivers’ self-esteem was measured by the Rosenberg Self-Esteem Scale at post-treatment (9 weeks) and follow-up (1 month). No significant between-group difference was found at either time point.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that a web-based psychoeducational intervention is not more effective than no treatment in improving self-esteem in patients with stroke and their caregivers.

Stroke outcomes
Not effective
1a

Two high quality RCTs (Ostwald et al., 2014; Saal et al., 2015) investigated the effect of a stroke psychosocial education program on stroke outcomes in patients with stroke.

The first high quality RCT (Ostwald et al., 2014) randomized patients with acute / subacute / chronic stroke and their caregivers to receive home-based psychosocial education + mailed information or mailed information alone. Stroke outcomes were measured by the Stroke Impact Scale (SIS – Physical, Emotion, Memory, Communication, Social participation, Stroke recovery subscores) at post-treatment (6 months) and at follow-up (12 months). No significant between-group difference was found at either time point.

The second high quality RCT (Saal et al., 2015) randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). Stroke outcomes were measured by the SIS (Physical domain score) at post-treatment (1 year). Significant between-group difference was found favoring mailed information alone vs. stroke education and support intervention.

Conclusion: There is strong evidence (Level 1a) from two high quality RCTs that a stroke psychosocial education program is not more effective than a comparison intervention (mailed information alone) in improving stroke outcomes in patients with stroke.
Note:
In fact, one high quality RCT found that stroke education + support was LESS effective than mailed information alone.

Stroke recurrence
Not effective
1b

One high quality RCT (Saal et al., 2015) investigated the effect of a stroke psychosocial education program on the incidence of recurrent stroke(s) in patients with stroke. This high quality RCT randomized patients with acute/subacute stroke to receive stroke education + support (home-based visits, mailed information, educational sessions) or mailed information alone (2 brochures). The incidence of recurrent stroke(s) was measured at post-treatment (1 year). No significant between-group difference was found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that stroke education and support is not more effective than a comparison intervention (mailed information alone) in reducing the incidence of recurrent stroke(s) in patients with stroke.

Phase not specific to one period - Tai Chi

Depression
Not effective
1b

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on depression in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Depression was measured by the Center for Epidemiologic Studies Depression Scale at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that Tai Chi is not more effective than comparison interventions (time-matched fitness program, standard care) in improving depression in patients with stroke.

Endurance
Effective
1b

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on endurance in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Endurance was measured by the 2-Minute Step Test at post-treatment (12 weeks). Significant between-group differences were found, favoring Tai Chi vs. standard care; and favoring the time-matched fitness program vs. standard care. There were no significant differences between Tai Chi and the time-matched fitness program.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that Tai Chi is more effective than a comparison intervention (standard care) in improving endurance in patients with stroke. It is not more effective than a time-matched fitness program.

Falls
Effective
1b

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on falls rate in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Falls rate was measured at post-treatment (12 weeks). Significant between-group differences were found, favoring Tai Chi vs. standard care. There were no significant differences between Tai Chi and the time-matched fitness program, or between the time-matched fitness program and standard care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that Tai Chi is more effective than a comparison intervention (standard care) in reducing the rate of falls in patients with stroke. It is not more effective than a time-matched fitness program.

Health related quality of life
Not effective
1b

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on health-related quality of life (HRQoL) in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. HRQoL was measured by the 36-Item Short-Form Survey (SF-36 – Physical Component Score, Mental Component Score) at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that Tai Chi is not more effective than comparison interventions (time-matched fitness program, standard care) in improving health-related quality of life in patients with stroke.

Mobility
Not effective
1b

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on mobility in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Mobility was measured by the Short-Form Performance Battery (SFPB – Total, Balance, Strength, Gait subscores) at post-treatment (12 weeks). There were no significant differences in any measure of mobility between Tai Chi and the time-matched fitness program, or Tai Chi and standard care.
Note: A significant between-group difference in one mobility score (SFPB – Strength) was found, favoring the time-matched fitness program vs. standard care.

Conclusion: There is moderate evidence (Level 1b) from one high quality RCT that Tai Chi is not more effective than comparison interventions (time-matched fitness program, standard care) in improving mobility in patients with stroke.

Sleep quality
Not effective
1b

One high quality RCT (Taylor-Piliae et al., 2014) investigated the effect of Tai Chi on sleep quality in patients with stroke. This high quality RCT randomized patients with subacute/chronic stroke to receive Tai Chi, a time-matched fitness program or standard care. Sleep quality was measured by the Pittsburgh Sleep Quality Index at post-treatment (12 weeks). No significant between-group differences were found.

Conclusion: There is moderate evidence (Level 1b) that Tai Chi is not more effective than comparison interventions (time-matched fitness program, standard care) in improving sleep quality in patients with stroke.

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Excluded Studies

Aben, L., Heijenbrok-Kal, M. H., Ponds, R. W., Busschbach, J. J., & Ribbers, G. M. (2014). Long-lasting effects of a new memory self-efficacy training for stroke patients: a randomized controlled trial. Neurorehabilitation and Neural Repair, 28(3), 199-206.
Reason for exclusion: Study part of COGNITIVE REHABILITATION module.

Aben, L., Heijenbrok-Kal, M. H., van Loon, E. M., Groet, E., Ponds, R. W., Busschbach, J. J., & Ribbers, G. M. (2013). Training memory self-efficacy in the chronic stage after stroke: a randomized controlled trial. Neurorehabilitation and Neural Repair, 27(2), 110-117.
Reason for exclusion: Study part of COGNITIVE REHABILITATION module.

Byl, N. N., Abrams, G. M., Pitsch, E., Fedulow, I., Kim, H., Simkins, M., … & Rosen, J. (2013). Chronic stroke survivors achieve comparable outcomes following virtual task specific repetitive training guided by a wearable robotic orthosis (UL-EXO7) and actual task specific repetitive training guided by a physical therapist. Journal of Hand Therapy, 26(4), 343-352.
Reason for exclusion: Study part of ROBOTICS module.

Damush, T. M., Kroenke, K., Bair, M. J., Wu, J., Tu, W., Krebs, E. E., & Poleshuck, E. (2016). Pain self‐management training increases self‐efficacy, self‐management behaviours and pain and depression outcomes. European Journal of Pain, 20(7), 1070-1078.
Reason for exclusion: No population of interest.

Fary, K. H. A. N., & FAFRM, M. (2017). Effectiveness of a structured sexual rehabilitation programme following stroke: A randomized controlled trial. Journal of Rehabilitation Medicine, 49, 333-340.
Reason for exclusion: Stud part of SEXUALITY module

Hackett, M. L., Carter, G., Crimmins, D., Clarke, T., Arblaster, L., Billot, L., … & Sturm, J. (2013). ImProving Outcomes after STroke (POST): results from the randomized clinical pilot trial. International Journal of Stroke, 8(8), 707-710.
Reason for exclusion: Intervention consisted of sending a post-card to patients with stroke and not provided directly by rehabilitation professionals (OT/PT/SLP, etc.)

Johansson, B., Bjuhr, H., & Rönnbäck, L. (2012). Mindfulness-based stress reduction (MBSR) improves long-term mental fatigue after stroke or traumatic brain injury. Brain Injury, 26(13-14), 1621-1628.
Reason for exclusion: Intervention not performed within a rehabilitation context; not specified whether a rehabilitation professional delivered the intervention.

Joubert, J., Reid, C., Joubert, L., Barton, D., Ruth, D., Jackson, D., & Davis, S. M. (2006). Risk factor management and depression post-stroke: the value of an integrated model of care. Journal of Clinical Neuroscience, 13(1), 84-90.
Reason for exclusion: Intervention provided by MDs, not rehabilitation professionals (OT/PT/SLP, etc.)

Jun, E. M., Roh, Y. H., & Kim, M. J. (2013). The effect of music‐movement therapy on physical and psychological states of stroke patients. Journal of Clinical Nursing, 22(1-2), 22-31.
Reason for exclusion: Study part of MUSIC-BASED INTERVENTIONS module.

Khedr, E. M., Abo El-Fetoh, N., Ali, A. M., El-Hammady, D. H., Khalifa, H., Atta, H., & Karim, A. A. (2014). Dual-hemisphere repetitive transcranial magnetic stimulation for rehabilitation of poststroke aphasia: a randomized, double-blind clinical trial. Neurorehabilitation and Neural Repair, 28(8), 740-750.
Reason for exclusion: Study part of TMS module.

Kim, D. S., Park, Y. G., Choi, J. H., Im, S. H., Jung, K. J., Cha, Y. A., … & Yoon, Y. H. (2011). Effects of music therapy on mood in stroke patients. Yonsei Medical Journal, 52(6), 977-981.
Reason for exclusion: Study part of MUSIC-BASED INTERVENTIONS module.

Kirk, H., Kersten, P., Crawford, P., Keens, A., Ashburn, A., & Conway, J. (2014). The cardiac model of rehabilitation for reducing cardiovascular risk factors post transient ischaemic attack and stroke: a randomized controlled trial. Clinical Rehabilitation, 28(4), 339-349.
Reason for exclusion: Depression as secondary outcome.

Lempka, S. F., Malone, D. A., Hu, B., Baker, K. B., Wyant, A., Ozinga, J. G., … & Machado, A. G. (2017). Randomized clinical trial of deep brain stimulation for poststroke pain. Annals of Neurology, 81(5), 653-663.
Reason for exclusion: Study part of TMS/BRAIN STIMULATION module.

Linder, S. M., Rosenfeldt, A. B., Bay, R. C., Sahu, K., Wolf, S. L., & Alberts, J. L. (2015). Improving quality of life and depression after stroke through telerehabilitation. American Journal of Occupational Therapy, 69(2), 6902290020p1-6902290020p10.
Reason for exclusion: Study part of ROBOTICS module.

Man, S. C., Hung, B. H., Ng, R. M., Yu, X. C., Cheung, H., Fung, M. P., … & Ziea, E. (2014). A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complementary and Alternative Medicine, 14(1), 255.
Reason for exclusion: Study part of ACUPUNCTURE module.

Mayo, N. E., Anderson, S., Barclay, R., Cameron, J. I., Desrosiers, J., Eng, J. J., … & Richards, C. L. (2015). Getting on with the rest of your life following stroke: a randomized trial of a complex intervention aimed at enhancing life participation post stroke. Clinical Rehabilitation, 29(12), 1198-1211.
Reason for exclusion: Study part of LEISURE/PARTICIPATION module.

Qian, X., Zhou, X., You, Y., Shu, S., Fang, F., Huang, S., & Zhou, S. (2015). Traditional chinese acupuncture for poststroke depression: A single-blind double-simulated randomized controlled trial. The Journal of Alternative and Complementary Medicine, 21(12), 748-753.
Reason for exclusion: Study part of ACUPUNCTURE module (excluded as both groups received a form of acupuncture treatment).

Renner, C. I., Outermans, J., Ludwig, R., Brendel, C., Kwakkel, G., & Hummelsheim, H. (2016). Group therapy task training versus individual task training during inpatient stroke rehabilitation: A randomised controlled trial. Clinical Rehabilitation, 30(7), 637-648.
Reason for exclusion: Study part of LOWER EXTREMITIES TASK-ORIENTED module.

Rochette, A., Korner-Bitensky, N., Bishop, D., Teasell, R., White, C. L., Bravo, G., … & Kapral, M. (2013). The YOU CALL–WE CALL Randomized Clinical Trial: Impact of a Multimodal Support Intervention After a Mild Stroke. Circulation: Cardiovascular Quality and Outcomes, 6(6), 674-679.
Reason for exclusion: Depression as a secondary outcome.

Sackley, C. M., Walker, M. F., Burton, C. R., Watkins, C. L., Mant, J., Roalfe, A. K., … & Fletcher-Smith, J. (2015). An occupational therapy intervention for residents with stroke related disabilities in UK care homes (OTCH): cluster randomised controlled trial. BMJ, 350, h468.
Reason for exclusion: Depression as secondary outcome.

Taricco, M., Dallolio, L., Calugi, S., Rucci, P., Fugazzaro, S., Stuart, M., … & EFG [Esercizio Fisico di Gruppo]/2009 Investigators. (2014). Impact of adapted physical activity and therapeutic patient education on functioning and quality of life in patients with postacute strokes. Neurorehabilitation and Neural Repair, 28(8), 719-728.
Reason for exclusion: Depression as a secondary outcome; not a RCT.

Thanakiatpinyo, T., Suwannatrai, S., Suwannatrai, U., Khumkaew, P., Wiwattamongkol, D., Vannabhum, M., … & Kuptniratsaikul, V. (2014). The efficacy of traditional Thai massage in decreasing spasticity in elderly stroke patients. Clinical Interventions in Aging, 9, 1311.
Reason for exclusion: Depression as a secondary outcome.

Visser, M. M., Heijenbrok-Kal, M. H., van‘t Spijker, A., Lannoo, E., Busschbach, J. J., & Ribbers, G. M. (2016). Problem-solving therapy during outpatient stroke rehabilitation improves coping and health-related quality of life: randomized controlled trial. Stroke, 47(1), 135-142.
Reason for exclusion: Depression as a secondary outcome.

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