Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211835
Status:
COMPLETED
Last Update Posted:
2013-09-24
First Post:
2005-09-13
Brief Title:
Treatment of Post-TBI Depression
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Treatment of Post-TBI Depression - A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2013-09
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:
Randomized clinical trial that compares the effects of cognitive behavioral therapy CBT and supportive psychotherapy for depression Short- and long-term outcomes will be evaluated in terms of changes in mood primarily depression and anxiety participation in activities and life satisfaction
Detailed Description:
Goals Demonstrate the efficacy of cognitive behavioral therapy CBT both immediately after treatment and in the long term in alleviating post-TBI depression
Examine the relationship between improved mood participation and life satisfaction
Implement exploratory analyses of the relationships between person and injury characteristics and outcomes of treatment
Maximize potential application to clinical practice by
Implementing the treatment in a clinical context so that its utility is demonstrated in a setting that maximizes ecological validity and Creating and disseminating a manual detailing CBT treatment This study is a randomized clinical trial that compares two treatment conditions CBT and supportive psychotherapy SPT CBT has been shown to be effective in diverse studies In this study CBT has been shaped to be used specifically with people with typical post-TBI cognitive challenges All participants will be given an opportunity to immediately receive a randomly assigned psychotherapy intervention to potentially enhance coping Both CBT and SPT will involve 16 sessions of individual treatment The initial session will be 90 minutes with remaining sessions 50 minutes In both treatments participants will be seen for three months with sessions twice weekly for the first month and once a week subsequently The research assistants who will administer pre- and postintervention evaluation instruments will be blind to each participants randomly assigned treatment condition Evaluation instruments will be administered at baseline and at three points of follow-up one week six months and one year after treatment A detailed manual describing treatment methods will be developed based on the intervention
Examine the relationship between improved mood participation and life satisfaction
Implement exploratory analyses of the relationships between person and injury characteristics and outcomes of treatment
Maximize potential application to clinical practice by
Implementing the treatment in a clinical context so that its utility is demonstrated in a setting that maximizes ecological validity and Creating and disseminating a manual detailing CBT treatment This study is a randomized clinical trial that compares two treatment conditions CBT and supportive psychotherapy SPT CBT has been shown to be effective in diverse studies In this study CBT has been shaped to be used specifically with people with typical post-TBI cognitive challenges All participants will be given an opportunity to immediately receive a randomly assigned psychotherapy intervention to potentially enhance coping Both CBT and SPT will involve 16 sessions of individual treatment The initial session will be 90 minutes with remaining sessions 50 minutes In both treatments participants will be seen for three months with sessions twice weekly for the first month and once a week subsequently The research assistants who will administer pre- and postintervention evaluation instruments will be blind to each participants randomly assigned treatment condition Evaluation instruments will be administered at baseline and at three points of follow-up one week six months and one year after treatment A detailed manual describing treatment methods will be developed based on the intervention
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 |
|---|---|---|---|
| H133B040033 | None | None | None |