The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women (TREM)
Primary Purpose
Post-Traumatic Stress Disorder, Mental Disorders, Depression
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Trauma Recovery and Empowerment Model (TREM)
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Physical Abuse, Sexual Abuse, Women, Trauma, Group Therapy, Substance Abuse
Eligibility 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
Sites / Locations
- Community Connections
- The North Baltimore Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Participants will receive Trauma Recovery and Empowerment Model and usual care
Participants will receive usual care
Outcomes
Primary Outcome Measures
PTSD symptom severity
Secondary Outcome Measures
Distorted beliefs
Depressive symptoms
Substance use
Mental health service utilization
Full Information
NCT ID
NCT00183716
First Posted
September 14, 2005
Last Updated
July 20, 2012
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00183716
Brief Title
The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women
Acronym
TREM
Official Title
An Randomized Controlled Trial (RCT) of the Trauma Recovery and Empowerment Model
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder, Mental Disorders, Depression
Keywords
PTSD, Physical Abuse, Sexual Abuse, Women, Trauma, Group Therapy, Substance Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive Trauma Recovery and Empowerment Model and usual care
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Trauma Recovery and Empowerment Model (TREM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Participants will receive usual care for women who have experienced psychological trauma.
Primary Outcome Measure Information:
Title
PTSD symptom severity
Time Frame
Measured at baseline and Months 6, 12, and 18
Secondary Outcome Measure Information:
Title
Distorted beliefs
Time Frame
Measured at baseline and Months 6, 12, and 18
Title
Depressive symptoms
Time Frame
Measured at baseline and Months 6, 12, and 18
Title
Substance use
Time Frame
Measured at baseline and Months 6, 12, and 18
Title
Mental health service utilization
Time Frame
Measured at Months 6, 12, and 18
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory J. McHugo, PhD
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Connections
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
The North Baltimore Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women
We'll reach out to this number within 24 hrs