search
Back to results

Women Overcoming and Managing Adversity Now (WOMAN) Study (WOMAN)

Primary Purpose

Posttraumatic Stress Disorder, PTSD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TARGET
SGT
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Women, PTSD, Group Therapy, Incarceration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • York Correctional Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TARGET

SGT

Arm Description

12-session affect regulation therapy for PTSD

12 session supportive group therapy

Outcomes

Primary Outcome Measures

PTSD
PTSD symptom severity, Clinician Administered PTSD Scale
PTSD
PTSD symptom severity, Clinician Administered PTSD Scale

Secondary Outcome Measures

Emotion Regulation
Negative Mood Regulation Scale
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).
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
Emotion Regulation
Negative Mood Regulation Scale
Trauma-related Symptoms
Trauma Symptom Inventory
Mental health symptoms, well-being, and self-harm
CORE-OM 34-item questionnaire

Full Information

First Posted
September 23, 2010
Last Updated
March 28, 2011
Sponsor
UConn Health
search

1. Study Identification

Unique Protocol Identification Number
NCT01324765
Brief Title
Women Overcoming and Managing Adversity Now (WOMAN) Study
Acronym
WOMAN
Official Title
Women Overcoming and Managing Adversity Now (WOMAN) Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UConn Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, PTSD
Keywords
Women, PTSD, Group Therapy, Incarceration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TARGET
Arm Type
Experimental
Arm Description
12-session affect regulation therapy for PTSD
Arm Title
SGT
Arm Type
Active Comparator
Arm Description
12 session supportive group therapy
Intervention Type
Behavioral
Intervention Name(s)
TARGET
Intervention Description
12-session group therapy twice weekly 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
SGT
Intervention Description
12 sessions supportive group therapy twice weekly 6 weeks
Primary Outcome Measure Information:
Title
PTSD
Description
PTSD symptom severity, Clinician Administered PTSD Scale
Time Frame
Post-therapy (within 2 weeks)
Title
PTSD
Description
PTSD symptom severity, Clinician Administered PTSD Scale
Time Frame
3-4 Month Post-therapy Follow-up
Secondary Outcome Measure Information:
Title
Emotion Regulation
Description
Negative Mood Regulation Scale
Time Frame
Post-therapy (within 2 weeks)
Title
Trauma-related symptoms
Description
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).
Time Frame
Post-therapy (within 2 weeks)
Title
Mental health symptoms, well-being, and self-harm
Description
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
Time Frame
Post-therapy (within 2 weeks)
Title
Emotion Regulation
Description
Negative Mood Regulation Scale
Time Frame
3-4 Month Post-therapy Follow-up
Title
Trauma-related Symptoms
Description
Trauma Symptom Inventory
Time Frame
3-4 Month Post-therapy Follow-up
Title
Mental health symptoms, well-being, and self-harm
Description
CORE-OM 34-item questionnaire
Time Frame
3-4 Month Post-therapy Follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian D Ford, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
York Correctional Institution
City
Niantic
State/Province
Connecticut
ZIP/Postal Code
06357
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Women Overcoming and Managing Adversity Now (WOMAN) Study

We'll reach out to this number within 24 hrs