Alcohol Use Disorders (AUDs) and Post-traumatic Stress Disorder (PTSD) Treatment for Victims of Partner Violence

May 10, 2011 updated by: University of California, San Diego

AUDs and PTSD Treatment for Victims of Partner Violence

The goal of this study is to evaluate a psychotherapy for PTSD and substance use disorders among women who have experienced domestic violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use after treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to evaluate an integrated psychotherapy for PTSD and substance use disorders among female victims of intimate partner violence. The hypothesis is that women who receive present-focused, integrated treatment will have greater PTSD symptom reduction and have less substance use post-treatment than women in the control condition who will receive supportive therapy based on a 12-step approach.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD Outpatient Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female victims of partner violence
  • at least one month out of the abusive relationship
  • meet DSM-IV (American Psychiatric Association, 1994) criteria for PTSD and an alcohol use disorder
  • literate in English
  • have not changed psychotropic medications or dosages within the past two months and agree not to during the active phase (first 12 weeks) of the intervention
  • have an identified primary care physician

Exclusion Criteria:

  • moderate or severe cognitive impairment as measured by a Mini-Mental State Examination score less than or equal to 18
  • Histories of psychosis or mania may be excluded because the presence of these disorders is thought to impede progress in psychotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Present focused, integrated psychotherapy for PTSD and substance use disorders
Behavioral: Integrated psychotherapy for PTSD and substance use
integrated, present focused psychotherapy for PTSD and substance use disorders tailored to women who have experienced intimate partner violence
Active Comparator: 2
Supportive therapy using 12-step model
Behavioral: 12-step based supportive therapy
supportive psychotherapy based on 12-step model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CAPS for PTSD symptoms and ASI for substance use
Time Frame: pre, mid treatment, post, 3-month follow-up, 6-month follow-up
pre, mid treatment, post, 3-month follow-up, 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Timeline Follow-back procedure, Beck Depression Inventory
Time Frame: same as primary
same as primary

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Sonya Norman, UCSD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

May 11, 2011

Last Update Submitted That Met QC Criteria

May 10, 2011

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23AA015707 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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