NCT00194454

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2002

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

September 23, 2008

Status Verified

September 1, 2008

Enrollment Period

5.9 years

First QC Date

September 12, 2005

Last Update Submit

September 21, 2008

Conditions

Stroke

Keywords

Depressive symptomsBehavior and behavior mechanismsRecovery

Outcome Measures

Primary Outcomes (1)

  • Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke.

    12 months following stroke

Secondary Outcomes (3)

  • Reduction in limitations in activity (Barthel Index)6, 12, 24 months

    6, 12, 24 months following intervention

  • Reduction in limitation in participation (Stroke Impact Scale)6, 12, 24 months

    6, 12, 24 months following intervention

  • Overall stroke impact (Stroke Impact Scale)6,12,24 months post- stroke.

    6, 12, 24 months following stroke

Study Arms (2)

1

EXPERIMENTAL

Nine session psychosocial/behavioral counseling with homework

Behavioral: Modified cognitive behavioral therapy plus problem-solving

2

ACTIVE COMPARATOR

Usual clinic care with booklet describing depression following stroke

Other: usual care

Interventions

Modified cognitive behavioral therapy plus problem-solvingBEHAVIORAL

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.

1
usual careOTHER

Usual care with primary provider plus a booklet about mood and behavioral changes following stroke

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic stroke within previous 4 months Screens positive for depressive symptoms by Geriatric Depression Scale Able to provide informed consent -

You may not qualify if:

  • Subarachnoid or intracranial hemorrhagic stroke Global aphasia Reduced level of consciousness (GCS \<15)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195-7266, United States

Location

Related Publications (3)

  • 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.

    PMID: 18436150BACKGROUND

  • 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.

    PMID: 21847802DERIVED

  • 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.

    PMID: 19661478DERIVED

MeSH Terms

Conditions

StrokeDepressionBehavior

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral Symptoms

Study Officials

  • Pamela H Mitchell, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

March 1, 2002

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 23, 2008

Record last verified: 2008-09

Locations

US(1)