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Psychosocial/Behavioral Intervention in Post-Stroke Depression

Psychosocial/Behavioral Intervention in PSD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00194454
Enrollment
101
Registered
2005-09-19
Start date
2002-03-31
Completion date
2008-02-29
Last updated
2008-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Depressive symptoms, Behavior and behavior mechanisms, Recovery

Brief 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).

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).

Interventions

BEHAVIORALModified 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.

OTHERusual care

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

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke.12 months following stroke

Secondary

MeasureTime frame
Reduction in limitations in activity (Barthel Index)6, 12, 24 months6, 12, 24 months following intervention
Reduction in limitation in participation (Stroke Impact Scale)6, 12, 24 months6, 12, 24 months following intervention
Overall stroke impact (Stroke Impact Scale)6,12,24 months post- stroke.6, 12, 24 months following stroke

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026