The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women

Phase 3

Completed

• Conditions: Post-Traumatic Stress Disorder; Mental Disorders; Depression
• Interventions: Behavioral: Trauma Recovery and Empowerment Model (TREM); Behavioral: Usual care

• Registration Number: NCT00183716
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-20
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Trauma Recovery and Empowerment Model (TREM)	Participants will receive Trauma Recovery and Empowerment Model and usual care
1	Usual care	Participants will receive Trauma Recovery and Empowerment Model and usual care
2	Usual care	Participants will receive usual care

Primary Outcome Measures

Name	Time	Method
PTSD symptom severity	Measured at baseline and Months 6, 12, and 18

Secondary Outcome Measures

Name	Time	Method
Distorted beliefs	Measured at baseline and Months 6, 12, and 18
Depressive symptoms	Measured at baseline and Months 6, 12, and 18
Substance use	Measured at baseline and Months 6, 12, and 18
Mental health service utilization	Measured at Months 6, 12, and 18

Trial Locations

Locations (2)

Community Connections; 🇺🇸 Washington, District of Columbia, United States

The North Baltimore Center; 🇺🇸 Baltimore, Maryland, United States