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

Phase 1

Completed

Conditions: Post-traumatic Stress Disorder
Alcohol-related Disorders

Interventions: Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD

Registration Number: NCT00946322

Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 13

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: CTAP	Couple-Based Treatment for Alcohol Use Disorders and PTSD	Couple-Based Treatment for Alcohol Use Disorders and PTSD

Primary Outcome Measures

Name	Time	Method
Patient-reported PTSD Checklist	Pre- to post-treatment (~20 weeks)	Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.
Percentage Days of Heavy Drinking	Pre- to post-treatment (~20 weeks)	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.
Clinician-administered PTSD Scale (CAPS)	Pre- to post-treatment (~20 weeks)	Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.
Partner-reported PTSD Checklist	Pre- to post-treatment (~20 weeks)	Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.

Secondary Outcome Measures

Name	Time	Method
Patient-reported Beck Depression Inventory - II (BDI-II)	Pre- to post-treatment	Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.
Patient-reported Dyadic Adjustment Scale	Pre- to post-treatment (~20 weeks)	Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.
Partner-reported Beck Depression Inventory - II	Pre- to post-treatment (~20 weeks)	Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.
Partner-reported Dyadic Adjustment Scale	Pre- to post-treatment (~20 weeks)	Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.