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Randomized Controlled Trial
. 2008 May-Jun;17(3):109-15.
doi: 10.1016/j.jstrokecerebrovasdis.2007.12.002.

Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression

Pamela H Mitchell  1 , Linda Teri, Richard Veith, Ann Buzaitis, David Tirschwell, Kyra Becker, Michael Fruin, Ruth Kohen, Kevin C Cain
Affiliations
Randomized Controlled Trial

Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression

Pamela H Mitchell et al. J Stroke Cerebrovasc Dis. 2008 May-Jun.

Abstract

Background: Depression is a sufficiently common sequela of a completed stroke to warrant intervention to improve mood, social, and functional outcome. Pharmacologic trials suggest short-term mood improvement from antidepressant treatment but no studies to date have determined whether these short-term gains can be enhanced and extended by a brief psychosocial/behavioral intervention delivered by advanced practice nurses. In addition, drug trials have not reported on functional outcomes such as limitations in ability, limitations in participation, and overall quality of survival. This randomized controlled trial was designed to evaluate the short- and long-term efficacy of a new brief psychosocial/behavioral intervention adjunctive to antidepressant treatment in reducing poststroke depression and improving functional outcomes.

Methods: A total of 101 survivors of ischemic stroke with poststroke depression were randomly assigned to receive a brief psychosocial/behavioral intervention plus antidepressant or usual care, including antidepressants.

Results: The primary outcome was reduction in depressive symptom severity (Hamilton Depression Rating Scale) at 12 months after stroke. Secondary outcomes were reductions in limitations in activity (Barthel Index), reduction in limitation in participation, and overall stroke impact (Stroke Impact Scale) at 6, 12, and 24 months poststroke. Factors influencing best response to psychosocial intervention were also explored.

Conclusion: This article provides detail on the design and treatment methods of this randomized trial in progress. Findings from this study provide important information regarding the long-term efficacy of such a behavioral intervention in reducing poststroke depression and subsequent impaired aspects of psychosocial and physical recovery.

Trial registration: ClinicalTrials.gov NCT00194454.

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