Psychosocial/Behavioral Intervention in Post-Stroke Depression (PSD)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cerebrovascular Stroke
- Sponsor
- University of Washington
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Hamilton Rating Scale for Depression (HRSD)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Pamela Mitchell
Professor, School of Nursing
University of Washington
Eligibility Criteria
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
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).
Outcomes
Primary Outcomes
Hamilton Rating Scale for Depression (HRSD)
Time Frame: 1 year post-treatment
Remission is defined as an HRSD score of 9 or less on the 17 item scale
Secondary Outcomes
- Stroke Impact Scale (SIS)(1 year post treatment)