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

An Randomized Controlled Trial (RCT) of the Trauma Recovery and Empowerment Model

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorders; Depression; Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Trauma Recovery and Empowerment Model (TREM); Behavioral: Usual care

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20003
      • Community Connections
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • The North Baltimore Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2; Participants will receive usual care	Behavioral: Usual care; Participants will receive usual care for women who have experienced psychological trauma.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PTSD symptom severity	Measured at baseline and Months 6, 12, and 18

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Gregory J. McHugo, PhD, Dartmouth College

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): July 23, 2012
• Last Update Submitted That Met QC Criteria: July 20, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: PTSD; Women; Trauma; Substance Abuse; Group Therapy; Sexual Abuse; Physical Abuse
• Additional Relevant MeSH Terms: Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders
• Other Study ID Numbers: R01MH068252 (U.S. NIH Grant/Contract); DSIR 83-ATAS (NIMH Program Class Code)