Clinical trial NCT00194454: Psychosocial/Behavioral Intervention in Post-Stroke Depression
Official title: Psychosocial/Behavioral Intervention in PSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Depressive symptoms
Behavior and behavior mechanisms
Recovery
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2005-09-19
Enrollment: 101
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke.
timeFrame: 12 months following stroke
Secondary outcomes:
measure: Reduction in limitations in activity (Barthel Index)6, 12, 24 months
timeFrame: 6, 12, 24 months following intervention
measure: Reduction in limitation in participation (Stroke Impact Scale)6, 12, 24 months
timeFrame: 6, 12, 24 months following intervention
measure: Overall stroke impact (Stroke Impact Scale)6,12,24 months post- stroke.
timeFrame: 6, 12, 24 months following stroke
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Pamela H Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell PH, Teri L, Veith R, Buzaitis A, Tirschwell D, Becker K, Fruin M, Kohen R, Cain KC. Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression. J Stroke Cerebrovasc Dis. 2008 May-Jun;17(3):109-15. doi: 10.1016/j.jstrokecerebrovasdis.2007.12.002.
citation: Kohen R, Cain KC, Buzaitis A, Johnson V, Becker KJ, Teri L, Tirschwell DL, Veith RC, Mitchell PH. Response to psychosocial treatment in poststroke depression is associated with serotonin transporter polymorphisms. Stroke. 2011 Jul;42(7):2068-70. doi: 10.1161/strokeaha.110.611434.
citation: Mitchell PH, Veith RC, Becker KJ, Buzaitis A, Cain KC, Fruin M, Tirschwell D, Teri L. Brief psychosocial-behavioral intervention with antidepressant reduces poststroke depression significantly more than usual care with antidepressant: living well with stroke: randomized, controlled trial. Stroke. 2009 Sep;40(9):3073-8. doi: 10.1161/STROKEAHA.109.549808. Epub 2009 Aug 6.