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Women Overcoming and Managing Adversity Now (WOMAN) Study

U

UConn Health

Status and phase

Completed
Phase 3
Phase 2

Conditions

Posttraumatic Stress Disorder
PTSD

Treatments

Behavioral: TARGET
Behavioral: SGT

Study type

Interventional

Funder types

Other

Identifiers

NCT01324765
09009-2
2009-DD-BX-0003 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

108 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 2 patient groups

TARGET
Experimental group
Description:
12-session affect regulation therapy for PTSD
Treatment:
Behavioral: TARGET
SGT
Active Comparator group
Description:
12 session supportive group therapy
Treatment:
Behavioral: SGT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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