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

NCT ID: NCT00183716

Last Updated: 2012-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Post-Traumatic Stress Disorder Mental Disorders Depression

Keywords

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PTSD Physical Abuse Sexual Abuse Women Trauma Group Therapy Substance Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive Trauma Recovery and Empowerment Model and usual care

Group Type EXPERIMENTAL

Trauma Recovery and Empowerment Model (TREM)

Intervention Type 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

Intervention Type BEHAVIORAL

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

2

Participants will receive usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Usual care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory J. McHugo, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Locations

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Community Connections

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

Site Status

The North Baltimore Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH068252

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 83-ATAS

Identifier Type: -

Identifier Source: secondary_id

R01MH068252

Identifier Type: NIH

Identifier Source: org_study_id

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