The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women (TREM)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Traumatic Stress Disorder Mental Disorders Depression |
Behavioral: Trauma Recovery and Empowerment Model (TREM) Behavioral: Usual care |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An Randomized Controlled Trial (RCT) of the Trauma Recovery and Empowerment Model |
- PTSD symptom severity [ Time Frame: Measured at baseline and Months 6, 12, and 18 ] [ Designated as safety issue: No ]
- Distorted beliefs [ Time Frame: Measured at baseline and Months 6, 12, and 18 ] [ Designated as safety issue: No ]
- Depressive symptoms [ Time Frame: Measured at baseline and Months 6, 12, and 18 ] [ Designated as safety issue: Yes ]
- Substance use [ Time Frame: Measured at baseline and Months 6, 12, and 18 ] [ Designated as safety issue: No ]
- Mental health service utilization [ Time Frame: Measured at Months 6, 12, and 18 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2004 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive Trauma Recovery and Empowerment Model and usual care
|
Behavioral: Trauma Recovery and Empowerment Model (TREM)
TREM is a 29-session group intervention for women who have experienced psychological trauma (e.g., childhood physical or sexual abuse), focusing on skill development, understanding the effects of trauma, and empowerment.
Behavioral: Usual care
Participants will receive usual care for women who have experienced psychological trauma.
|
|
Active Comparator: 2
Participants will receive usual care
|
Behavioral: Usual care
Participants will receive usual care for women who have experienced psychological trauma.
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of physical and/or sexual abuse
- Diagnosis of a severe mental disorder
- Diagnosis of PTSD with a symptom severity score of 21 or higher
Exclusion Criteria:
- Severe developmental disabilities or organic brain damage
Contacts and Locations| United States, District of Columbia | |
| Community Connections | |
| Washington, District of Columbia, United States, 20003 | |
| United States, Maryland | |
| The North Baltimore Center | |
| Baltimore, Maryland, United States, 21218 | |
| Principal Investigator: | Gregory J. McHugo, PhD | Dartmouth-Hitchcock Medical Center |
More Information
No publications provided
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00183716 History of Changes |
| Other Study ID Numbers: | R01 MH68252, R01MH068252, DSIR 83-ATAS |
| Study First Received: | September 14, 2005 |
| Last Updated: | July 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
PTSD Physical Abuse Sexual Abuse Women |
Trauma Group Therapy Substance Abuse |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Depression Depressive Disorder Stress Disorders, Post-Traumatic |
Stress Disorders, Traumatic Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms Mood Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on May 22, 2013