Women Overcoming and Managing Adversity Now (WOMAN) Study

This study has been completed.
Sponsor:
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT01324765
First received: September 23, 2010
Last updated: March 28, 2011
Last verified: March 2011

September 23, 2010
March 28, 2011
January 2009
November 2010   (final data collection date for primary outcome measure)
  • PTSD [ Time Frame: Post-therapy (within 2 weeks) ] [ Designated as safety issue: No ]
    PTSD symptom severity, Clinician Administered PTSD Scale
  • PTSD [ Time Frame: 3-4 Month Post-therapy Follow-up ] [ Designated as safety issue: No ]
    PTSD symptom severity, Clinician Administered PTSD Scale
Same as current
Complete list of historical versions of study NCT01324765 on ClinicalTrials.gov Archive Site
  • Emotion Regulation [ Time Frame: Post-therapy (within 2 weeks) ] [ Designated as safety issue: No ]
    Negative Mood Regulation Scale
  • Trauma-related symptoms [ Time Frame: Post-therapy (within 2 weeks) ] [ Designated as safety issue: No ]
    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).
  • Mental health symptoms, well-being, and self-harm [ Time Frame: Post-therapy (within 2 weeks) ] [ Designated as safety issue: Yes ]
    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
  • Emotion Regulation [ Time Frame: 3-4 Month Post-therapy Follow-up ] [ Designated as safety issue: No ]
    Negative Mood Regulation Scale
  • Trauma-related Symptoms [ Time Frame: 3-4 Month Post-therapy Follow-up ] [ Designated as safety issue: No ]
    Trauma Symptom Inventory
  • Mental health symptoms, well-being, and self-harm [ Time Frame: 3-4 Month Post-therapy Follow-up ] [ Designated as safety issue: Yes ]
    CORE-OM 34-item questionnaire
Same as current
Not Provided
Not Provided
 
Women Overcoming and Managing Adversity Now (WOMAN) Study
Women Overcoming and Managing Adversity Now (WOMAN) Study

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).

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder
  • PTSD
  • Behavioral: TARGET
    12-session group therapy twice weekly 6 weeks
  • Behavioral: SGT
    12 sessions supportive group therapy twice weekly 6 weeks
  • Experimental: TARGET
    12-session affect regulation therapy for PTSD
    Intervention: Behavioral: TARGET
  • Active Comparator: SGT
    12 session supportive group therapy
    Intervention: Behavioral: SGT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
November 2010
November 2010   (final data collection date for primary outcome measure)

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).
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01324765
09009-2, 2009-DD-BX-0003
No
Julian D. Ford, University of Connecticut Health Center
University of Connecticut Health Center
Not Provided
Principal Investigator: Julian D Ford, Ph.D. University of Connecticut Health Center
University of Connecticut Health Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP