Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042198
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2002-07-24
Brief Title:
Treatment of Depression After Coronary Bypass Surgery
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Treatment of Depression After Coronary Bypass Surgery
Status:
COMPLETED
Status Verified Date:
2013-07
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:
This randomized controlled trial will test the efficacy of 1 cognitive behavior therapy and 2 supportive stress management as treatments for depression in people who have recently undergone coronary artery bypass graft surgery
Detailed Description:
Depression is a very common problem for people who have had CABG surgery and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery Cognitive behavior therapy CBT has been shown to be efficacious for depression in otherwise healthy individuals and supportive stress management SSM interventions have also been shown to improve depressive symptoms These therapies have not however been tested for depression in individuals who have undergone CABG surgery
Participants will be screened for depression within 1 year after CABG surgery Those who have depression will return for additional testing 1 week later Eligible participants will be randomized to receive CBT SSM or usual care UC with no restrictions on nonstudy antidepressants for 12 weeks Patients will be monitored for worsening depression referred for additional care if needed Depression anxiety and health-related quality of life will be assessed at baseline 12 weeks after randomization and 6 months after surgery 2 months after termination of CBT or SSM
Participants will be screened for depression within 1 year after CABG surgery Those who have depression will return for additional testing 1 week later Eligible participants will be randomized to receive CBT SSM or usual care UC with no restrictions on nonstudy antidepressants for 12 weeks Patients will be monitored for worsening depression referred for additional care if needed Depression anxiety and health-related quality of life will be assessed at baseline 12 weeks after randomization and 6 months after surgery 2 months after termination of CBT or SSM
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 |
|---|---|---|---|
| DSIR AT-AS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH060735 |
| R01MH060735 | NIH | None | None |