Psychosocial/Behavioral Intervention in Post-Stroke Depression

Study Overview
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Brief Summary
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The primary aim of this study is to determine the effect of a nurse-delivered psychosocial/behavioral intervention on reduction of depression in community dwelling post-stroke patients. We expect the combined behavioral and pharmacologic intervention to be more effective than pharmacotherapy alone in sustaining the improvement in depression for the experimental group. Secondary aims are to examine the effect of the psychosocial/behavioral intervention time course and sustainability of response to treatment, effect on limitations in ability, limitation in participation and overall stroke impact in community-dwelling post-stroke patients, and to compare ischemic stroke survivors who are and are not depressed within the first four months following stroke by their 5-HTTLPR genotypes (s/s, s/l, or l/l).

Detailed Description
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150 patients at University of Washington affiliated hospitals who are found to be depressed by DSMIV criteria within the first four months following ischemic stroke will be invited to join the study, and randomly assigned to a problem-solving/pleasant events intervention provided by an advanced practice nurse, or to regular clinic follow-up. Both groups will receive standard antidepressant treatment and written materials from the American Stroke Association, and will be assessed for up to two years following the study. The primary outcome is reduction in depression at 12 months following stroke. Secondary outcomes are reductions in limitations in activity (Barthel Index), reduction in limitation in participation (Stroke Impact Scale) and overall stroke impact (Stroke Impact Scale) at 6, 12, and 24 months post- stroke. We hypothesize that all patients will improve their mood and functional ability related to their post-stroke standard treatment, but that those who receive the psychosocial intervention will have significantly greater improvement in mood, functional ability, social participation, and less overall stroke impact at all follow-up measurement. A supplemental aim is to expand aim 4 of the parent study, adding SERT genotype to our list of factors that might influence treatment outcome for PSD. Further, since we are screening both depressed and not depressed stroke survivors for this study, we will add a fifth aim: to compare ischemic stroke survivors who are and are not depressed within the first four months following stroke by their 5-HTTLPR genotypes (s/s, s/l, or l/l).

Official Title
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Psychosocial/Behavioral Intervention in PSD

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Modified cognitive behavioral therapy plus problem-solving
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic stroke within previous 4 months Screens positive for depressive symptoms by Geriatric Depression Scale Able to provide informed consent - Exclusion Criteria: Subarachnoid or intracranial hemorrhagic stroke Global aphasia Reduced level of consciousness (GCS <15)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nine session psychosocial/behavioral counseling with homework | Behavioral: Modified cognitive behavioral therapy plus problem-solving<br>* 9 sessions with a psychosocial nurse practitioner in which participants learn to use behavioral strategies and specific problem-solving approaches to reduce or prevent behavioral and mood disturbances characteristic of stroke.<br>|
| Active Comparator: 2<br>Usual clinic care with booklet describing depression following stroke | Other: usual care<br>* Usual care with primary provider plus a booklet about mood and behavioral changes following stroke<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke. |  | 12 months following stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in limitations in activity (Barthel Index)6, 12, 24 months |  | 6, 12, 24 months following intervention | 
| Reduction in limitation in participation (Stroke Impact Scale)6, 12, 24 months |  | 6, 12, 24 months following intervention | 
| Overall stroke impact (Stroke Impact Scale)6,12,24 months post- stroke. |  | 6, 12, 24 months following stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive symptoms, Behavior and behavior mechanisms, Recovery