Women Overcoming and Managing Adversity Now (WOMAN) Study

Phase 2

Completed

• Conditions: Posttraumatic Stress Disorder; PTSD
• Interventions: Behavioral: TARGET; Behavioral: SGT

• Registration Number: NCT01324765
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-09-23
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-03
• Study First Submitted QC: 2011-03-28
• Last Update Submitted: 2011-03-28
• Study First Posted: 2011-03-29
• Last Update Posted: 2011-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TARGET	TARGET	12-session affect regulation therapy for PTSD
SGT	SGT	12 session supportive group therapy

Primary Outcome Measures

Name	Time	Method
PTSD	3-4 Month Post-therapy Follow-up	PTSD symptom severity, Clinician Administered PTSD Scale

Secondary Outcome Measures

Name	Time	Method
Emotion Regulation	3-4 Month Post-therapy Follow-up	Negative Mood Regulation Scale
Trauma-related symptoms	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).
Mental health symptoms, well-being, and self-harm	3-4 Month Post-therapy Follow-up	CORE-OM 34-item questionnaire
Trauma-related Symptoms	3-4 Month Post-therapy Follow-up	Trauma Symptom Inventory

Trial Locations

Locations (1)

York Correctional Institution; 🇺🇸 Niantic, Connecticut, United States