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

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183716

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 III

MedlinePlus related topics: Depression Injuries Mental Health Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	An Randomized Controlled Trial (RCT) of the Trauma Recovery and Empowerment Model

Further study details as provided by National Institute of Mental Health (NIMH):

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
Estimated Study Completion Date:	March 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Gregory J. McHugo, PhD

Dartmouth-Hitchcock Medical Center

More Information

Responsible Party:	Dartmouth Medical School ( Gregory J. McHugo )
Study ID Numbers:	R01 MH68252, DSIR 83-ATAS
Study First Received:	September 14, 2005
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00183716
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

PTSD
Physical Abuse
Sexual Abuse
Women

Trauma
Group Therapy
Substance Abuse

Study placed in the following topic categories:

Depression
Anxiety Disorders
Mental Disorders
Wounds and Injuries
Stress Disorders, Post-Traumatic

Stress
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 15, 2009