Women Overcoming and Managing Adversity Now (WOMAN) Study (WOMAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01324765
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : March 29, 2011
Information provided by:
UConn Health

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).

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder PTSD Behavioral: TARGET Behavioral: SGT Phase 2 Phase 3

Detailed Description:
In a randomized treatment design, we will compare offenders receiving skills-based intervention (TARGET) and those receiving a similar amount of supportive intervention (SGT). We will assess the efficacy of treatment by determining if those receiving the TARGET skills training show an improvement in functionality, as compared to those receiving only supportive intervention. We will measure this by analyzing PTSD symptoms, psychological distress, psychosocial functioning, and social/legal adjustment and services using structured interviews, self-report questionnaires and qualitative questions. Questionnaires are listed below in the outcome measure's section. We will collect follow-up data on program participants who successfully finish the program at York. For those offenders who discharge into the community directly from York, we will collect follow-up data on program participants through CDOC Parole or Probation records. Statistically we anticipate a medium effect size difference between the treatment conditions.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Women Overcoming and Managing Adversity Now (WOMAN) Study
Study Start Date : January 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: TARGET
12-session affect regulation therapy for PTSD
Behavioral: TARGET
12-session group therapy twice weekly 6 weeks

Active Comparator: SGT
12 session supportive group therapy
Behavioral: SGT
12 sessions supportive group therapy twice weekly 6 weeks

Primary Outcome Measures :
  1. PTSD [ Time Frame: Post-therapy (within 2 weeks) ]
    PTSD symptom severity, Clinician Administered PTSD Scale

  2. PTSD [ Time Frame: 3-4 Month Post-therapy Follow-up ]
    PTSD symptom severity, Clinician Administered PTSD Scale

Secondary Outcome Measures :
  1. Emotion Regulation [ Time Frame: Post-therapy (within 2 weeks) ]
    Negative Mood Regulation Scale

  2. Trauma-related symptoms [ Time Frame: Post-therapy (within 2 weeks) ]
    Trauma Symptom Inventory (TSI; Briere, 1995). The TSI is a reliable and validated 100-item measure that generates composite scores for trauma (PTSD symptoms), self (self-regulation problems), and dysphoria (depression, anxiety, anger symptoms).

  3. Mental health symptoms, well-being, and self-harm [ Time Frame: Post-therapy (within 2 weeks) ]
    CORE-OM is a 34-item self-report measure reliably and validly assessing current psychiatric symptom severity, risk of harm to self or others, social functioning, and subjective well being

  4. Emotion Regulation [ Time Frame: 3-4 Month Post-therapy Follow-up ]
    Negative Mood Regulation Scale

  5. Trauma-related Symptoms [ Time Frame: 3-4 Month Post-therapy Follow-up ]
    Trauma Symptom Inventory

  6. Mental health symptoms, well-being, and self-harm [ Time Frame: 3-4 Month Post-therapy Follow-up ]
    CORE-OM 34-item questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Incarcerated, release not expected within 6 months
  • Probable PTSD on PC-PTSD screen and PTSD by CAPS interview

Exclusion Criteria

  • Clinically significant psychopathy (PCL-SV severe range)
  • Unable to comprehend study materials (Mini-Mental Status Exam Orientation, Attention, and Recall sections total score <15).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01324765

United States, Connecticut
York Correctional Institution
Niantic, Connecticut, United States, 06357
Sponsors and Collaborators
UConn Health
Principal Investigator: Julian D Ford, Ph.D. UConn Health

Responsible Party: Julian D. Ford, University of Connecticut Health Center Identifier: NCT01324765     History of Changes
Other Study ID Numbers: 09009-2
2009-DD-BX-0003 ( Other Grant/Funding Number: Department of Justice )
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: March 29, 2011
Last Verified: March 2011

Keywords provided by UConn Health:
Group Therapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders