Psychosocial/Behavioral Intervention in Post-Stroke Depression

NCT00194454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2008-09-23

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00194454 on ClinicalTrials.gov