Women Overcoming and Managing Adversity Now (WOMAN) Study

PTSD Clinical Trial

— WOMAN  

Official title:

Women Overcoming and Managing Adversity Now (WOMAN) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324765
• Other study ID #: 09009-2
• Secondary ID: 2009-DD-BX-0003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 23, 2010
• Last updated: March 28, 2011
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2011
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• TARGET
12-session group therapy twice weekly 6 weeks
• SGT
12 sessions supportive group therapy twice weekly 6 weeks

Locations

Country	Name	City	State
United States	York Correctional Institution	Niantic	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD	PTSD symptom severity, Clinician Administered PTSD Scale	Post-therapy (within 2 weeks)	No
Primary	PTSD	PTSD symptom severity, Clinician Administered PTSD Scale	3-4 Month Post-therapy Follow-up	No
Secondary	Emotion Regulation	Negative Mood Regulation Scale	Post-therapy (within 2 weeks)	No
Secondary	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)	No
Secondary	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)	Yes
Secondary	Emotion Regulation	Negative Mood Regulation Scale	3-4 Month Post-therapy Follow-up	No
Secondary	Trauma-related Symptoms	Trauma Symptom Inventory	3-4 Month Post-therapy Follow-up	No
Secondary	Mental health symptoms, well-being, and self-harm	CORE-OM 34-item questionnaire	3-4 Month Post-therapy Follow-up	Yes