Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194454
Status:
COMPLETED
Last Update Posted:
2008-09-23
First Post:
2005-09-12
Brief Title:
PsychosocialBehavioral Intervention in Post-Stroke Depression
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
PsychosocialBehavioral Intervention in PSD
Status:
COMPLETED
Status Verified Date:
2008-09
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:
None
Brief Summary:
The primary aim of this study is to determine the effect of a nurse-delivered psychosocialbehavioral intervention on reduction of depression in community dwelling post-stroke patients We expect the combined behavioral and pharmacologic intervention to be more effective than pharmacotherapy alone in sustaining the improvement in depression for the experimental group Secondary aims are to examine the effect of the psychosocialbehavioral intervention time course and sustainability of response to treatment effect on limitations in ability limitation in participation and overall stroke impact in community-dwelling post-stroke patients and to compare ischemic stroke survivors who are and are not depressed within the first four months following stroke by their 5-HTTLPR genotypes ss sl or ll
Detailed Description:
150 patients at University of Washington affiliated hospitals who are found to be depressed by DSMIV criteria within the first four months following ischemic stroke will be invited to join the study and randomly assigned to a problem-solvingpleasant events intervention provided by an advanced practice nurse or to regular clinic follow-up Both groups will receive standard antidepressant treatment and written materials from the American Stroke Association and will be assessed for up to two years following the study The primary outcome is reduction in depression at 12 months following stroke Secondary outcomes are reductions in limitations in activity Barthel Index reduction in limitation in participation Stroke Impact Scale and overall stroke impact Stroke Impact Scale at 6 12 and 24 months post- stroke We hypothesize that all patients will improve their mood and functional ability related to their post-stroke standard treatment but that those who receive the psychosocial intervention will have significantly greater improvement in mood functional ability social participation and less overall stroke impact at all follow-up measurement A supplemental aim is to expand aim 4 of the parent study adding SERT genotype to our list of factors that might influence treatment outcome for PSD Further since we are screening both depressed and not depressed stroke survivors for this study we will add a fifth aim to compare ischemic stroke survivors who are and are not depressed within the first four months following stroke by their 5-HTTLPR genotypes ss sl or ll
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 |
|---|---|---|---|
| 5R01NR007755-04 | NIH | None | httpsreporternihgovquickSearch5R01NR007755-04 |