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
  Purpose

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 Intervention Phase
Posttraumatic Stress Disorder
PTSD
Behavioral: TARGET
Behavioral: SGT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Women Overcoming and Managing Adversity Now (WOMAN) Study

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 108
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324765

Locations
United States, Connecticut
York Correctional Institution
Niantic, Connecticut, United States, 06357
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Julian D Ford, Ph.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Julian D. Ford, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT01324765     History of Changes
Other Study ID Numbers: 09009-2, 2009-DD-BX-0003
Study First Received: September 23, 2010
Last Updated: March 28, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Connecticut Health Center:
Women
PTSD
Group Therapy
Incarceration

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 22, 2014