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Completed

NCT Number: NCT00183716

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

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.

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Key information

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Community Connections, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma Recovery and Empowerment Model (TREM)

Behavioral

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

Behavioral

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

Primary outcomes

  1. PTSD symptom severity

    Time frame: Measured at baseline and Months 6, 12, and 18

Secondary outcomes

  1. Distorted beliefs

    Time frame: Measured at baseline and Months 6, 12, and 18

  2. Depressive symptoms

    Time frame: Measured at baseline and Months 6, 12, and 18

  3. Substance use

    Time frame: Measured at baseline and Months 6, 12, and 18

  4. Mental health service utilization

    Time frame: Measured at Months 6, 12, and 18

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: TREM

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Jul 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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