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Women Overcoming and Managing Adversity Now (WOMAN) Study

Women Overcoming and Managing Adversity Now (WOMAN) Study

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01324765
Acronym
WOMAN
Enrollment
108
Registered
2011-03-29
Start date
2009-01-31
Completion date
2010-11-30
Last updated
2011-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder, PTSD

Keywords

Women, PTSD, Group Therapy, Incarceration

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.

Interventions

BEHAVIORALTARGET

12-session group therapy twice weekly 6 weeks

BEHAVIORALSGT

12 sessions supportive group therapy twice weekly 6 weeks

Sponsors

UConn Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
PTSDPost-therapy (within 2 weeks)PTSD symptom severity, Clinician Administered PTSD Scale

Secondary

MeasureTime frameDescription
Emotion RegulationPost-therapy (within 2 weeks)Negative Mood Regulation Scale
Trauma-related symptomsPost-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-harmPost-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
Trauma-related Symptoms3-4 Month Post-therapy Follow-upTrauma Symptom Inventory

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026