Women Overcoming and Managing Adversity Now (WOMAN) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of a School-Based, Trauma-Informed CBT Intervention for Young Women

NCT03376633

Anxiety Anxiety Disorders Behavioral Symptoms +6 more

COMPLETED NA

Mothers Overcoming and Managing Stress

NCT00751244

Posttraumatic Stress Disorder PTSD

COMPLETED PHASE2

Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse

NCT00069381

Stress Disorders, Post-Traumatic

COMPLETED NA

Self-Help Cognitive Processing Therapy (CPT)/Women Veterans Network (WoVeN) Study

NCT07250061

Posttraumatic Stress Disorder Depression

NOT_YET_RECRUITING NA

A Randomized Clinical Trial of Cognitive-Behavioral Treatment for Post-Traumatic Stress Disorders in Women

NCT00032617

Stress Disorders, Post-Traumatic

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder PTSD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TARGET

12-session affect regulation therapy for PTSD

Group Type EXPERIMENTAL

TARGET

Intervention Type BEHAVIORAL

12-session group therapy twice weekly 6 weeks

SGT

12 session supportive group therapy

Group Type ACTIVE_COMPARATOR

SGT

Intervention Type BEHAVIORAL

12 sessions supportive group therapy twice weekly 6 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TARGET

12-session group therapy twice weekly 6 weeks

Intervention Type BEHAVIORAL

SGT

12 sessions supportive group therapy twice weekly 6 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No