MedDataX Logo

Psychosocial/Behavioral Intervention in Post-Stroke Depression

NCT ID: NCT00194454

Last Updated: 2008-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2008-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Depressive symptoms Behavior and behavior mechanisms Recovery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Nine session psychosocial/behavioral counseling with homework

Group Type EXPERIMENTAL

Modified cognitive behavioral therapy plus problem-solving

Intervention Type BEHAVIORAL

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.

2

Usual clinic care with booklet describing depression following stroke

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type OTHER

Usual care with primary provider plus a booklet about mood and behavioral changes following stroke

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

usual care

Usual care with primary provider plus a booklet about mood and behavioral changes following stroke

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Washington

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pamela H Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Mitchell PH, Teri L, Veith R, Buzaitis A, Tirschwell D, Becker K, Fruin M, Kohen R, Cain KC. Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression. J Stroke Cerebrovasc Dis. 2008 May-Jun;17(3):109-15. doi: 10.1016/j.jstrokecerebrovasdis.2007.12.002.

Reference Type BACKGROUND
PMID: 18436150 (View on PubMed)

Kohen R, Cain KC, Buzaitis A, Johnson V, Becker KJ, Teri L, Tirschwell DL, Veith RC, Mitchell PH. Response to psychosocial treatment in poststroke depression is associated with serotonin transporter polymorphisms. Stroke. 2011 Jul;42(7):2068-70. doi: 10.1161/strokeaha.110.611434.

Reference Type DERIVED
PMID: 21847802 (View on PubMed)

Mitchell PH, Veith RC, Becker KJ, Buzaitis A, Cain KC, Fruin M, Tirschwell D, Teri L. Brief psychosocial-behavioral intervention with antidepressant reduces poststroke depression significantly more than usual care with antidepressant: living well with stroke: randomized, controlled trial. Stroke. 2009 Sep;40(9):3073-8. doi: 10.1161/STROKEAHA.109.549808. Epub 2009 Aug 6.

Reference Type DERIVED
PMID: 19661478 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5R01NR007755-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00-3203-V 06

Identifier Type: -

Identifier Source: org_study_id