Living Well With Stroke

Not Applicable

Completed

• Conditions: Cerebrovascular Stroke; Depression
• Interventions: Behavioral: Brief pleasurable events/behavioral therapy; Other: Standard care

• Registration Number: NCT01133106
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

This is the second phase of a study whose aim was to evaluate the short and long-term efficacy of a brief psychosocial/behavioral intervention (with adjunctive antidepressant)for the treatment of post-stroke depression (PSD) in survivors of ischemic stroke (registered as clinical trail NCT00194454). In the earlier trial we demonstrated that a pleasant event/problem-solving brief psychosocial-behavioral therapy delivered by psychosocial nurse practitioners was highly effective in treating major depression and promoting remission in ischemic stroke survivors for up to two years. In this phase, we refine the protocol, and potentially make it more cost effective, by conducting a randomized comparative effectiveness trial of in-person versus telephone delivery of the intervention, comparing with usual care control. We also seek to expand our sample to include hemorrhagic stroke survivors (intraparenchymal hemorrhage and subarachnoid hemorrhage) as well as those with ischemic stroke.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-28
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• hospitalized for an ischemic or hemorrhagic stroke (intraparenchymal hemorrhage- IPH or subarachnoid hemorrhage - SAH) in the past 3 months
• clinical depression symptoms (Geriatric Depression Score -GDS >= 11

Read More

Exclusion Criteria

• major psychiatric co-morbidity
• active suicidal ideation without ability to contract for safety
• current substance abuse
• physical inability to tolerate 1-2 hour sessions
• receptive or global aphasia
• reduced level of consciousness (GCS<15).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-person behavioral intervention	Brief pleasurable events/behavioral therapy	behavioral counseling plus antidepressant treatment prescribed by participant's own provider; consisted of orientation session plus 6 counseling sessions in person with a psychosocial nurse practitioner
Standard care	Standard care	participants have orientation to the study with the same written materials given those in the experimental arms. Keep a medication log and keep appointments with their own post-stroke provider
Telephone behavioral intervention	Brief pleasurable events/behavioral therapy	This arm is identical to the in-person Arm except that the intervention is delivered by telephone instead of in-person.

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HRSD)	1 year post-treatment	Remission is defined as an HRSD score of 9 or less on the 17 item scale

Secondary Outcome Measures

Name	Time	Method
Stroke Impact Scale (SIS)	1 year post treatment	The SIS has multiple scales measuring limitations in activity, in social participation and perceived overall stroke impact (perceived percent recovery)

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States