Psychosocial/Behavioral Intervention in Post-Stroke Depression

Completed

Phase N/A Results N/A

Trial Description

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).

Conditions

Interventions

  • Usual care Other
    Intervention Desc: Usual care with primary provider plus a booklet about mood and behavioral changes following stroke
    ARM 1: Kind: Experimental
    Label: 2
    Description: Usual clinic care with booklet describing depression following stroke
  • Modified cognitive behavioral therapy plus problem-solving Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Nine session psychosocial/behavioral counseling with homework

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke. 12 months following stroke No
Secondary Reduction in limitations in activity (Barthel Index)6, 12, 24 months 6, 12, 24 months following intervention No
Secondary Reduction in limitation in participation (Stroke Impact Scale)6, 12, 24 months 6, 12, 24 months following intervention No
Secondary Overall stroke impact (Stroke Impact Scale)6,12,24 months post- stroke. 6, 12, 24 months following stroke No

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