Women Overcoming and Managing Adversity Now (WOMAN) Study
WOMAN
2 other identifiers
interventional
108
1 country
1
Brief Summary
The goal of the study is to evaluate the efficacy of a two therapeutic models designed to enhance women's skills for managing reactive emotions in their current lives as well as to educate them about how using these skills can enhance their personal effectiveness and help them to gain control of post-traumatic stress reactions. The interventions adaptations of a manualized psychotherapy that has shown promise with adults with complex Posttraumatic Stress Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET) compared to a supportive group therapy (SGT) that has been found to have modest benefits with women survivors of childhood abuse (Wallis, 2002).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2009
1 active site
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
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
March 29, 2011
CompletedMarch 29, 2011
March 1, 2011
1.8 years
September 23, 2010
March 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PTSD
PTSD symptom severity, Clinician Administered PTSD Scale
Post-therapy (within 2 weeks)
PTSD
PTSD symptom severity, Clinician Administered PTSD Scale
3-4 Month Post-therapy Follow-up
Secondary Outcomes (6)
Emotion Regulation
Post-therapy (within 2 weeks)
Trauma-related symptoms
Post-therapy (within 2 weeks)
Mental health symptoms, well-being, and self-harm
Post-therapy (within 2 weeks)
Emotion Regulation
3-4 Month Post-therapy Follow-up
Trauma-related Symptoms
3-4 Month Post-therapy Follow-up
- +1 more secondary outcomes
Study Arms (2)
TARGET
EXPERIMENTAL12-session affect regulation therapy for PTSD
SGT
ACTIVE COMPARATOR12 session supportive group therapy
Interventions
Eligibility Criteria
You may qualify if:
- Incarcerated, release not expected within 6 months
- Probable PTSD on PC-PTSD screen and PTSD by CAPS interview
You may not qualify if:
- Clinically significant psychopathy (PCL-SV severe range)
- Unable to comprehend study materials (Mini-Mental Status Exam Orientation, Attention, and Recall sections total score \<15).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UConn Healthlead
Study Sites (1)
York Correctional Institution
Niantic, Connecticut, 06357, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julian D Ford, Ph.D.
UConn Health
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 23, 2010
First Posted
March 29, 2011
Study Start
January 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
March 29, 2011
Record last verified: 2011-03