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

• ClinicalTrials.gov Identifier: NCT00607412
• Recruitment Status: Completed
• First Posted: February 5, 2008
• Last Update Posted: May 11, 2011
• Sponsor: University of California, San Diego
• Information provided by: University of California, San Diego

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
PTSD; Substance Use Disorders	Behavioral: Integrated psychotherapy for PTSD and substance use; Behavioral: 12-step based supportive therapy	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: AUDs and PTSD Treatment for Victims of Partner Violence
• Study Start Date: August 2007
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. CAPS for PTSD symptoms and ASI for substance use [ Time Frame: pre, mid treatment, post, 3-month follow-up, 6-month follow-up ]

Secondary Outcome Measures :

1. Timeline Follow-back procedure, Beck Depression Inventory [ Time Frame: same as primary ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hameed M, O'Doherty L, Gilchrist G, Tirado-Muñoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7:CD013017. doi: 10.1002/14651858.CD013017.pub2.

Myers US, Browne KC, Norman SB. Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder. J Dual Diagn. 2015;11(3-4):238-47. doi: 10.1080/15504263.2015.1113762.

• Responsible Party: Sonya Norman, PhD, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT00607412
• Other Study ID Numbers: K23AA015707 ( U.S. NIH Grant/Contract ); K23AA015707 ( U.S. NIH Grant/Contract )
• First Posted: February 5, 2008
• Last Update Posted: May 11, 2011
• Last Verified: June 2009

Keywords provided by University of California, San Diego:

PTSD; substance use disorders; psychotherapy

Additional relevant MeSH terms:

Substance-Related Disorders; Mental Disorders; Chemically-Induced Disorders