Women Overcoming and Managing Adversity Now (WOMAN) Study - Full Text View

Purpose

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).

Condition	Intervention	Phase
Posttraumatic Stress Disorder PTSD	Behavioral: TARGET Behavioral: SGT	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Women Overcoming and Managing Adversity Now (WOMAN) Study

Resource links provided by NLM:

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:

PTSD [ Time Frame: Post-therapy (within 2 weeks) ] [ Designated as safety issue: No ]
PTSD symptom severity, Clinician Administered PTSD Scale
PTSD [ Time Frame: 3-4 Month Post-therapy Follow-up ] [ Designated as safety issue: No ]
PTSD symptom severity, Clinician Administered PTSD Scale

Secondary Outcome Measures:

Emotion Regulation [ Time Frame: Post-therapy (within 2 weeks) ] [ Designated as safety issue: No ]
Negative Mood Regulation Scale
Trauma-related symptoms [ Time Frame: Post-therapy (within 2 weeks) ] [ Designated as safety issue: No ]
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-harm [ Time Frame: Post-therapy (within 2 weeks) ] [ Designated as safety issue: Yes ]
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
Emotion Regulation [ Time Frame: 3-4 Month Post-therapy Follow-up ] [ Designated as safety issue: No ]
Negative Mood Regulation Scale
Trauma-related Symptoms [ Time Frame: 3-4 Month Post-therapy Follow-up ] [ Designated as safety issue: No ]
Trauma Symptom Inventory
Mental health symptoms, well-being, and self-harm [ Time Frame: 3-4 Month Post-therapy Follow-up ] [ Designated as safety issue: Yes ]
CORE-OM 34-item questionnaire

Enrollment:	108
Study Start Date:	January 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: TARGET 12-session affect regulation therapy for PTSD	Behavioral: TARGET 12-session group therapy twice weekly 6 weeks
Active Comparator: SGT 12 session supportive group therapy	Behavioral: SGT 12 sessions supportive group therapy twice weekly 6 weeks

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324765

Locations

United States, Connecticut
York Correctional Institution
Niantic, Connecticut, United States, 06357

Sponsors and Collaborators

University of Connecticut Health Center

Investigators

Principal Investigator:

Julian D Ford, Ph.D.

University of Connecticut Health Center

More Information

No publications provided

Responsible Party:	Julian D. Ford, University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT01324765 History of Changes
Other Study ID Numbers:	09009-2, 2009-DD-BX-0003
Study First Received:	September 23, 2010
Last Updated:	March 28, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Connecticut Health Center:

Women
PTSD
Group Therapy
Incarceration

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 13, 2013