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Completed

NCT Number: NCT01324765

Women Overcoming and Managing Adversity Now (WOMAN) Study

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).

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Key information

Conditions

Posttraumatic Stress Disorder Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

York Correctional Institution

Niantic, Connecticut, 06357, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

TARGET

Behavioral

12-session group therapy twice weekly 6 weeks

SGT

Behavioral

12 sessions supportive group therapy twice weekly 6 weeks

Primary outcomes

  1. PTSD

    Time frame: Post-therapy (within 2 weeks)

    PTSD symptom severity, Clinician Administered PTSD Scale

  2. PTSD

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

    PTSD symptom severity, Clinician Administered PTSD Scale

Secondary outcomes

  1. Emotion Regulation

    Time frame: Post-therapy (within 2 weeks)

    Negative Mood Regulation Scale

  2. Trauma-related symptoms

    Time frame: 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).

  3. Mental health symptoms, well-being, and self-harm

    Time frame: Post-therapy (within 2 weeks)

    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

  4. Emotion Regulation

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

    Negative Mood Regulation Scale

  5. Trauma-related Symptoms

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

    Trauma Symptom Inventory

  6. Mental health symptoms, well-being, and self-harm

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

    CORE-OM 34-item questionnaire

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Registry information

Acronym: WOMAN

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 29, 2011
Registry last updated
Mar 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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