Psychosocial/Behavioral Intervention in Post-Stroke Depression
NCT00194454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2008-09-23
Summary
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).
Conditions
Interventions
- 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.
- OTHER
-
usual care
Usual care with primary provider plus a booklet about mood and behavioral changes following stroke
Sponsors & Collaborators
-
National Institute of Nursing Research (NINR)
collaborator NIH - lead OTHER
Principal Investigators
-
Pamela H Mitchell, PhD · University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-03-31
- Primary Completion
- 2008-02-29
- Completion
- 2008-02-29
Countries
- United States
Study Locations
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