Clinical Trials Directory

Trials / Completed

CompletedNCT01324765

Women Overcoming and Managing Adversity Now (WOMAN) Study

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
108 (actual)
Sponsor
UConn Health · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTARGET12-session group therapy twice weekly 6 weeks
BEHAVIORALSGT12 sessions supportive group therapy twice weekly 6 weeks

Timeline

Start date
2009-01-01
Primary completion
2010-11-01
Completion
2010-11-01
First posted
2011-03-29
Last updated
2011-03-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01324765. Inclusion in this directory is not an endorsement.