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

Dartmouth Health logo

Dartmouth Health

Status and phase

Completed
Phase 3

Conditions

Mental Disorders
Post-Traumatic Stress Disorder
Depression

Treatments

Behavioral: Trauma Recovery and Empowerment Model (TREM)
Behavioral: Usual care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00183716
DSIR 83-ATAS
R01MH068252 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups

1
Experimental group
Description:
Participants will receive Trauma Recovery and Empowerment Model and usual care
Treatment:
Behavioral: Trauma Recovery and Empowerment Model (TREM)
Behavioral: Usual care
2
Active Comparator group
Description:
Participants will receive usual care
Treatment:
Behavioral: Usual care

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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