Clinical trial NCT00946322: Couple-Based Treatment for Alcohol Use Disorders and Post-Traumatic Stress Disorder
Official title: Couple-Based Treatment for Alcohol Use Disorders and PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol-related Disorders
Post-traumatic Stress Disorder
Keywords: post-traumatic stress disorder
alcohol-related disorders
substance use disorders
couple therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-07-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinician-administered PTSD Scale (CAPS)
timeFrame: Pre- to post-treatment (~20 weeks)
measure: Percentage Days of Heavy Drinking
timeFrame: Pre- to post-treatment (~20 weeks)
measure: Patient-reported PTSD Checklist
timeFrame: Pre- to post-treatment (~20 weeks)
measure: Partner-reported PTSD Checklist
timeFrame: Pre- to post-treatment (~20 weeks)
Secondary outcomes:
measure: Patient-reported Beck Depression Inventory - II (BDI-II)
timeFrame: Pre- to post-treatment
measure: Patient-reported Dyadic Adjustment Scale
timeFrame: Pre- to post-treatment (~20 weeks)
measure: Partner-reported Beck Depression Inventory - II
timeFrame: Pre- to post-treatment (~20 weeks)
measure: Partner-reported Dyadic Adjustment Scale
timeFrame: Pre- to post-treatment (~20 weeks)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center, Cincinnati, OH
state: Ohio
Study officials:
affiliation: Cincinnati VA Medical Center, Cincinnati, OH
name: Jeremiah A. Schumm, PhD
role: PRINCIPAL_INVESTIGATOR
References: