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Clinical Trials/NCT01324765
NCT01324765
Completed
Phase 2

Women Overcoming and Managing Adversity Now (WOMAN) Study

UConn Health1 site in 1 country108 target enrollmentJanuary 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
UConn Health
Enrollment
108
Locations
1
Primary Endpoint
PTSD
Status
Completed
Last Updated
15 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
November 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
UConn Health

Eligibility 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).

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

PTSD

Time Frame: 3-4 Month Post-therapy Follow-up

PTSD symptom severity, Clinician Administered PTSD Scale

Secondary Outcomes

  • Emotion Regulation(3-4 Month Post-therapy Follow-up)
  • Trauma-related symptoms(Post-therapy (within 2 weeks))
  • Mental health symptoms, well-being, and self-harm(3-4 Month Post-therapy Follow-up)
  • Trauma-related Symptoms(3-4 Month Post-therapy Follow-up)

Study Sites (1)

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