Clinical trial NCT01324765: Women Overcoming and Managing Adversity Now (WOMAN) Study
Official title: Women Overcoming and Managing Adversity Now (WOMAN) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Posttraumatic Stress Disorder
PTSD
Keywords: Women
PTSD
Group Therapy
Incarceration
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: PTSD
timeFrame: Post-therapy (within 2 weeks)
measure: PTSD
timeFrame: 3-4 Month Post-therapy Follow-up
Secondary outcomes:
measure: Emotion Regulation
timeFrame: Post-therapy (within 2 weeks)
measure: Trauma-related symptoms
timeFrame: Post-therapy (within 2 weeks)
measure: Mental health symptoms, well-being, and self-harm
timeFrame: Post-therapy (within 2 weeks)
measure: Emotion Regulation
timeFrame: 3-4 Month Post-therapy Follow-up
measure: Trauma-related Symptoms
timeFrame: 3-4 Month Post-therapy Follow-up
measure: Mental health symptoms, well-being, and self-harm
timeFrame: 3-4 Month Post-therapy Follow-up
Other outcomes:
Locations:
city: Niantic
country: United States
facility: York Correctional Institution
state: Connecticut
Study officials:
affiliation: UConn Health
name: Julian D Ford, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: