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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00607412
First received: December 26, 2007
Last updated: May 10, 2011
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
PTSD
Substance Use Disorders
Behavioral: Integrated psychotherapy for PTSD and substance use
Behavioral: 12-step based supportive therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AUDs and PTSD Treatment for Victims of Partner Violence

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • CAPS for PTSD symptoms and ASI for substance use [ Time Frame: pre, mid treatment, post, 3-month follow-up, 6-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timeline Follow-back procedure, Beck Depression Inventory [ Time Frame: same as primary ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607412

Locations
United States, California
UCSD Outpatient Psychiatry
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Sonya Norman UCSD
  More Information

No publications provided

Responsible Party: Sonya Norman, PhD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00607412     History of Changes
Other Study ID Numbers: K23AA015707, K23AA015707
Study First Received: December 26, 2007
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
PTSD
substance use disorders
psychotherapy

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Anxiety Disorders
Mental Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 21, 2014