Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00183716
Status:
COMPLETED
Last Update Posted:
2012-07-23
First Post:
2005-09-14
Brief Title:
The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
An Randomized Controlled Trial RCT of the Trauma Recovery and Empowerment Model
Status:
COMPLETED
Status Verified Date:
2012-07
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:
TREM
Brief Summary:
This study will determine the effectiveness of the Trauma Recovery and Empowerment Model in reducing the severity of post-traumatic stress disorder symptoms in women with mental disorders and who have experienced sexual or physical abuse
Detailed Description:
Post-traumatic stress disorder PTSD is an anxiety disorder that can develop after exposure to a terrifying event in which grave physical harm occurred or was threatened Rates of PTSD are extremely high among people with severe mental disorders and such individuals find themselves at increased risk for depression substance abuse and poor overall health In turn these issues lead to high rates of utilization of mental health services Unfortunately there is currently a lack of effective trauma treatments that can be implemented in routine mental health settings Trauma Recovery and Empowerment Model TREM is a group-based intervention that addresses PTSD and other closely related consequences of sexual and physical abuse among women with severe mental disorders This study will determine the effectiveness of TREM in reducing the severity of PTSD symptoms in women with mental disorders who have experienced sexual or physical abuse
Participants in this open label study will be randomly assigned to receive either usual care alone or usual care combined with TREM for 18 months Usual care will include medication case management and therapy administered by a primary clinician Participants assigned to usual care will report to the study site at least once a week or as often as necessary Participants assigned to usual care plus TREM will also be assigned to a primary clinician and will receive usual care as often as necessary In addition TREM participants will take part in 29 group sessions that will focus on increasing self-esteem and trauma-coping skills and reducing self-blame PTSD symptom severity trauma beliefs depressive symptoms substance use and mental health service utilization will be measured at Months 6 12 and 18 for all participants
Participants in this open label study will be randomly assigned to receive either usual care alone or usual care combined with TREM for 18 months Usual care will include medication case management and therapy administered by a primary clinician Participants assigned to usual care will report to the study site at least once a week or as often as necessary Participants assigned to usual care plus TREM will also be assigned to a primary clinician and will receive usual care as often as necessary In addition TREM participants will take part in 29 group sessions that will focus on increasing self-esteem and trauma-coping skills and reducing self-blame PTSD symptom severity trauma beliefs depressive symptoms substance use and mental health service utilization will be measured at Months 6 12 and 18 for all participants
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 83-ATAS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH068252 |
| R01MH068252 | NIH | None | None |