Psychosocial/Behavioral Intervention in Post-Stroke Depression
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Stroke |
Behavioral: Modified cognitive behavioral therapy plus problem-solving Other: usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Psychosocial/Behavioral Intervention in PSD |
- Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke. [ Time Frame: 12 months following stroke ] [ Designated as safety issue: No ]
- Reduction in limitations in activity (Barthel Index)6, 12, 24 months [ Time Frame: 6, 12, 24 months following intervention ] [ Designated as safety issue: No ]
- Reduction in limitation in participation (Stroke Impact Scale)6, 12, 24 months [ Time Frame: 6, 12, 24 months following intervention ] [ Designated as safety issue: No ]
- Overall stroke impact (Stroke Impact Scale)6,12,24 months post- stroke. [ Time Frame: 6, 12, 24 months following stroke ] [ Designated as safety issue: No ]
| Enrollment: | 101 |
| Study Start Date: | March 2002 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Nine session psychosocial/behavioral counseling with homework
|
Behavioral: Modified cognitive behavioral therapy plus problem-solving
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.
|
|
Active Comparator: 2
Usual clinic care with booklet describing depression following stroke
|
Other: usual care
Usual care with primary provider plus a booklet about mood and behavioral changes following stroke
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98195-7266 | |
| Principal Investigator: | Pamela H Mitchell, PhD | University of Washington |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pamela H. Mitchell, Professor, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00194454 History of Changes |
| Other Study ID Numbers: | 00-3203-V 06, 5R01NR007755-04 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 21, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
Depressive symptoms Behavior and behavior mechanisms Recovery |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 16, 2013