Clinical trial NCT00183716: The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women
Official title: An Randomized Controlled Trial (RCT) of the Trauma Recovery and Empowerment Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Traumatic Stress Disorder
Mental Disorders
Depression
Keywords: PTSD
Physical Abuse
Sexual Abuse
Women
Trauma
Group Therapy
Substance Abuse
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD symptom severity
timeFrame: Measured at baseline and Months 6, 12, and 18
Secondary outcomes:
measure: Distorted beliefs
timeFrame: Measured at baseline and Months 6, 12, and 18
measure: Depressive symptoms
timeFrame: Measured at baseline and Months 6, 12, and 18
measure: Substance use
timeFrame: Measured at baseline and Months 6, 12, and 18
measure: Mental health service utilization
timeFrame: Measured at Months 6, 12, and 18
Other outcomes:
Locations:
city: Washington
country: United States
facility: Community Connections
state: District of Columbia
city: Baltimore
country: United States
facility: The North Baltimore Center
state: Maryland
Study officials:
affiliation: Dartmouth College
name: Gregory J. McHugo, PhD
role: PRINCIPAL_INVESTIGATOR
References: