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

PTSD Clinical Trial

Official title:

AUDs and PTSD Treatment for Victims of Partner Violence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607412
• Other study ID #: K23AA015707
• Secondary ID: K23AA015707
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: May 10, 2011
• Start date: August 2007
• Est. completion date: May 2011

Study information

• Verified date: June 2009
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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
• 12-step based supportive therapy
supportive psychotherapy based on 12-step model

Locations

Country	Name	City	State
United States	UCSD Outpatient Psychiatry	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAPS for PTSD symptoms and ASI for substance use		pre, mid treatment, post, 3-month follow-up, 6-month follow-up	No
Secondary	Timeline Follow-back procedure, Beck Depression Inventory		same as primary	No