Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01133106
Status:
COMPLETED
Last Update Posted:
2016-05-23
First Post:
2010-05-26
Brief Title:
Living Well With Stroke
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
PsychosocialBehavioral Intervention in Post-Stroke Depression PSD
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSD2
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 psychosocialbehavioral intervention with adjunctive antidepressantfor 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 eventproblem-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NR007755 | NIH | None | httpsreporternihgovquickSearchR01NR007755 |