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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00183716
First received: September 14, 2005
Last updated: July 20, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • PTSD symptom severity [ Time Frame: Measured at baseline and Months 6, 12, and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183716

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
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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 August 21, 2014