Journal of Stroke & Cerebrovascular Diseases
Volume 17, Issue 3 , Pages 109-115, May 2008

Living Well with Stroke: Design and Methods for a Randomized Controlled Trial of a Psychosocial Behavioral Intervention for Poststroke Depression

  • Pamela H. Mitchell, PhD

      Affiliations

    • Department of Biobehavioral Nursing and Health Systems, School of Nursing and School of Medicine, University of Washington, Seattle Washington
    • Corresponding Author InformationAddress correspondence to Pamela H. Mitchell, PhD, Box 357266, University of Washington, Seattle, WA 98195-7266.
    • ,
  • Linda Teri, PhD

      Affiliations

    • Department of Psychosocial and Community Health, School of Nursing and School of Medicine, University of Washington, Seattle Washington
    • ,
  • Richard Veith, MD

      Affiliations

    • Department of Psychiatry and Behavioral Sciences, School of Nursing and School of Medicine, University of Washington, Seattle Washington
    • ,
  • Ann Buzaitis, MN

      Affiliations

    • Department of Biobehavioral Nursing and Health Systems, School of Nursing and School of Medicine, University of Washington, Seattle Washington
    • ,
  • David Tirschwell, MD, MSc

      Affiliations

    • Department of Neurology, School of Nursing and School of Medicine, University of Washington, Seattle Washington
    • ,
  • Kyra Becker, MD

      Affiliations

    • Department of Neurology, School of Nursing and School of Medicine, University of Washington, Seattle Washington
    • ,
  • Michael Fruin, MN

      Affiliations

    • Department of Biobehavioral Nursing and Health Systems, School of Nursing and School of Medicine, University of Washington, Seattle Washington
    • ,
  • Ruth Kohen, MD

      Affiliations

    • Department of Psychiatry and Behavioral Sciences, School of Nursing and School of Medicine, University of Washington, Seattle Washington
    • ,
  • Kevin C. Cain, PhD

      Affiliations

    • Department of Biostatistics and Office for Nursing Research, School of Nursing and School of Medicine, University of Washington, Seattle Washington

Received 26 June 2007; received in revised form 13 November 2007; accepted 7 December 2007.

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.

Key Words: Poststroke depression, psychosocial treatment, efficacy trial

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 Supported by the National Institute of Nursing Research, National Institutes of Health grant No. R01NR007755 and registered with the clinical trials identifier: NCT00194454 http://www.clinicaltrials.gov/ct/show/NCT00194454?order=1.

PII: S1052-3057(07)00206-6

doi:10.1016/j.jstrokecerebrovasdis.2007.12.002

Journal of Stroke & Cerebrovascular Diseases
Volume 17, Issue 3 , Pages 109-115, May 2008

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