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


CONCLUSIONS
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.
Mitchell
Pamela H
PH
Department of Biobehavioral Nursing and Health Systems, School of Nursing and School of Medicine, University of Washington, Seattle, Washington 98195-7266, USA. pmitch@u.washington.edu
Teri
Linda
L
Veith
Richard
R
Buzaitis
Ann
A
Tirschwell
David
D
Becker
Kyra
K
Fruin
Michael
M
Kohen
Ruth
R
Cain
Kevin C
KC
D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000627:therapeutic use*; D001521:Behavior Therapy; D003131:Combined Modality Therapy; D003627:Data Interpretation, Statistical; D003863:Depression / Q000150:complications / Q000188:drug therapy / Q000235:genetics / Q000503:physiopathology / Q000628:therapy*; D004185:Disability Evaluation; D005260:Female; D005787:Gene Frequency; D005838:Genotype; D006801:Humans; D008297:Male; D008875:Middle Aged; D015205:Northwestern United States; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D050486:Serotonin Plasma Membrane Transport Proteins / Q000235:genetics; D012720:Severity of Illness Index; D020521:Stroke / Q000188:drug therapy / Q000235:genetics / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
D000928:Antidepressive Agents; C493230:SLC6A4 protein, human; D050486:Serotonin Plasma Membrane Transport Proteins