Depression Clinical Trial
Official title:
Psychosocial/Behavioral Intervention in Post-Stroke Depression (PSD)
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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