The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women
TREM
An Randomized Controlled Trial (RCT) of the Trauma Recovery and Empowerment Model
2 other identifiers
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2004
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedJuly 23, 2012
July 1, 2012
3.6 years
September 14, 2005
July 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTSD symptom severity
Measured at baseline and Months 6, 12, and 18
Secondary Outcomes (4)
Distorted beliefs
Measured at baseline and Months 6, 12, and 18
Depressive symptoms
Measured at baseline and Months 6, 12, and 18
Substance use
Measured at baseline and Months 6, 12, and 18
Mental health service utilization
Measured at Months 6, 12, and 18
Study Arms (2)
1
EXPERIMENTALParticipants will receive Trauma Recovery and Empowerment Model and usual care
2
ACTIVE COMPARATORParticipants will receive usual care
Interventions
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.
Participants will receive usual care for women who have experienced psychological trauma.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe developmental disabilities or organic brain damage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Community Connections
Washington D.C., District of Columbia, 20003, United States
The North Baltimore Center
Baltimore, Maryland, 21218, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory J. McHugo, PhD
Dartmouth College
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 16, 2005
Study Start
April 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
July 23, 2012
Record last verified: 2012-07