Psychosocial/Behavioral Intervention in Post-Stroke Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00194454
First received: September 12, 2005
Last updated: September 21, 2008
Last verified: September 2008
  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

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke. [ Time Frame: 12 months following stroke ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194454

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-7266
Sponsors and Collaborators
University of Washington
Investigators
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
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014