Couple-Based Treatment for Alcohol Use Disorders and Post-Traumatic Stress Disorder

Post-traumatic Stress Disorder Clinical Trial

— CTAP  

Official title:

Couple-Based Treatment for Alcohol Use Disorders and PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946322
• Other study ID #: CDA-2-019-09S
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2009
• Last updated: January 12, 2016
• Start date: August 2010
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop and test a couple-based treatment for Veterans with an alcohol use disorder and post-traumatic stress disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Veteran must meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) criteria for current (past 12 months) alcohol abuse or dependence and alcohol must be the Veteran's primary substance of abuse as determined by a clinical algorithm (Fals-Stewart, Stappenbeck et al, 2004);

• Veteran must meet DSM-IV criteria for current (past month) PTSD;

• Veteran consumed alcohol in the past 90 days;

• couple must be married to or living with their current partner for at least 1 year;

• Veteran agrees to a goal of abstinence from drugs at least for the duration of the 15-week study-based treatment;

• Veteran agrees to the goal of abstaining from alcohol or consuming alcohol within low risk drinking guidelines during the duration of the 15-week study-based counseling;

• Veteran agrees to forego other treatment for alcohol-related disorders except for self help meetings (e.g., AA) or treatment required for a clinical emergency or clinical deterioration for the duration of the 15-week study based treatment;

• Veteran agrees to forgo other PTSD treatment except for treatment required for a clinical emergency or clinical deterioration for the duration of the 15-week study based treatment;

• couple agrees to forgo other couple-based counseling for the duration of the 15-week study based treatment except for treatment required for a clinical emergency or clinical deterioration;

• partner does not meet DSM-IV criteria for current (past 12 month) substance use disorder (other than nicotine)

• partner does not meet DSM-IV criteria for current (past month) PTSD.

Exclusion Criteria:

• Veteran has dependence on alcohol or other drugs that requires inpatient treatment or medical detoxification (as indicated by daily heavy use or use to prevent or deal with withdrawal symptoms) - after completing detoxification, Veteran may be eligible for the study;

• Veteran or partner are at immediate risk for suicide or homicide (current plan or intent);

• Veteran or partner exhibit a history of suicide or homicide attempt in the past year;

• Veteran is participating in a methadone maintenance or suboxone maintenance program and is seeking treatment for adjunctive outpatient services;

• Veteran or partner meets DSM-IV criteria for a current organic mental disorder, schizophrenia, delusional (paranoid) disorder, or any of the other psychotic disorders.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Disease
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Couple-Based Treatment for Alcohol Use Disorders and PTSD
This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.

Locations

Country	Name	City	State
United States	Cincinnati VA Medical Center, Cincinnati, OH	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-administered PTSD Scale (CAPS)	Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.	Pre- to post-treatment (~20 weeks)	No
Primary	Percentage Days of Heavy Drinking	Percentage days of heavy drinking (PDHD) was calculated by dividing the number of days in which the Veteran consumed more than six standard drinks by the total days in the period. Both partners reported upon the Veterans' drinking behaviors. Following common practice in AUD research (e.g., McCrady, Epstein, Cook, Jensen, & Hildebrandt, 2011), we used the highest report of the two regarding PDHD to reduce possible underreporting. Possible range of scores 0-100%. Higher = worse.	Pre- to post-treatment (~20 weeks)	No
Primary	Patient-reported PTSD Checklist	Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.	Pre- to post-treatment (~20 weeks)	No
Primary	Partner-reported PTSD Checklist	Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.	Pre- to post-treatment (~20 weeks)	No
Secondary	Patient-reported Beck Depression Inventory - II (BDI-II)	Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.	Pre- to post-treatment	No
Secondary	Patient-reported Dyadic Adjustment Scale	Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.	Pre- to post-treatment (~20 weeks)	No
Secondary	Partner-reported Beck Depression Inventory - II	Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.	Pre- to post-treatment (~20 weeks)	No
Secondary	Partner-reported Dyadic Adjustment Scale	Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.	Pre- to post-treatment (~20 weeks)	No