Women Overcoming and Managing Adversity Now (WOMAN) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Women Overcoming and Managing Adversity Now (WOMAN) Study

Conditions
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Posttraumatic Stress Disorder, PTSD

Intervention / Treatment
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* Behavioral: TARGET
* Behavioral: SGT


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TARGET<br>12-session affect regulation therapy for PTSD | Behavioral: TARGET<br>* 12-session group therapy twice weekly 6 weeks<br>|
| Active Comparator: SGT<br>12 session supportive group therapy | Behavioral: SGT<br>* 12 sessions supportive group therapy twice weekly 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD | PTSD symptom severity, Clinician Administered PTSD Scale | Post-therapy (within 2 weeks) | 
| PTSD | PTSD symptom severity, Clinician Administered PTSD Scale | 3-4 Month Post-therapy Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion Regulation | Negative Mood Regulation Scale | Post-therapy (within 2 weeks) | 
| Trauma-related symptoms | 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). | Post-therapy (within 2 weeks) | 
| Mental health symptoms, well-being, and self-harm | 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 | Post-therapy (within 2 weeks) | 
| Emotion Regulation | Negative Mood Regulation Scale | 3-4 Month Post-therapy Follow-up | 
| Trauma-related Symptoms | Trauma Symptom Inventory | 3-4 Month Post-therapy Follow-up | 
| Mental health symptoms, well-being, and self-harm | CORE-OM 34-item questionnaire | 3-4 Month Post-therapy Follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Women, PTSD, Group Therapy, Incarceration