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

Study Overview
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Brief Summary
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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.

Official Title
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Couple-Based Treatment for Alcohol Use Disorders and PTSD

Conditions
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Alcohol-related Disorders, Post-traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: CTAP<br>Couple-Based Treatment for Alcohol Use Disorders and PTSD | Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD<br>* This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.<br>* Other names: CTAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-traumatic stress disorder, alcohol-related disorders, substance use disorders, couple therapy