Living Well With Stroke

Summary

The overall goal of this study is to conduct a three-armed randomized controlled trial (RCT) in stroke survivors with depression to determine if a brief psychosocial-behavioral therapy intervention delivered in-person (arm A) or by telephone (arm B) is better than usual care (arm C), in terms of percent reduction in depressive symptoms and % of participants achieving remission of symptoms.

Conditions

• Cerebrovascular Stroke
• Depression

Interventions

BEHAVIORAL

Brief pleasurable events/behavioral therapy

Each participant in any arm will be given an American Stroke Association article about stroke and depression, a Stroke Smart Article about caregiver depression, and a pamphlet by the Beck Institute titled "Coping with Depression". Each participant in Arms 1 and 2 will be given their own manual for the intervention sessions. The intervention consists of one in-person orientation session and 6 weekly sessions with the following topics introducing behavioral therapy, the role of pleasant events, problem-solving skills and generalization techniques. All participants' primary care provider or stroke care provider will receive a letter informing them of their patient's participation (but not of study assignment). This letter will include recommendations for prescribing and adjusting antidepressant treatment using established guidelines adapted for treatment of medically-ill outpatients.

OTHER

Standard care

The standard care group (Arm C, N=75) will receive standard medical treatment from their provider, including a recommendation for antidepressants. Participants or third-party payers will pay for their antidepressants, just as they would under regular care. All participants receive written materials regarding depression from the American Stroke Association, keep medication logs and receive follow-up assessment on the same time frame as the intervention groups

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Pamela H Mitchell, PhD · University of Washington

• Catherine J Kirkness, PhD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• United States

Study Locations