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

Depression Clinical Trial

— TREM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183716
• Other study ID #: R01MH068252
• Secondary ID: R01MH068252DSIR
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: July 20, 2012
• Start date: April 2004
• Est. completion date: November 2007

Study information

• Verified date: July 2012
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Disease
• Mental Disorders
• Post-Traumatic Stress Disorder
• Psychotic Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• Usual care
Participants will receive usual care for women who have experienced psychological trauma.

Locations

Country	Name	City	State
United States	The North Baltimore Center	Baltimore	Maryland
United States	Community Connections	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptom severity		Measured at baseline and Months 6, 12, and 18	No
Secondary	Distorted beliefs		Measured at baseline and Months 6, 12, and 18	No
Secondary	Depressive symptoms		Measured at baseline and Months 6, 12, and 18	Yes
Secondary	Substance use		Measured at baseline and Months 6, 12, and 18	No
Secondary	Mental health service utilization		Measured at Months 6, 12, and 18	No