Phase 1
N=12
Couple-Based Treatment for Alcohol Use Disorders and Post-Traumatic Stress Disorder
Alcohol-related Disorders · Post-traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00946322 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Clinician-administered PTSD Scale (CAPS) — 58.89; 40.22 units on a scale — p=.028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Couple-Based Treatment for Alcohol Use Disorders and PTSD (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician-administered PTSD Scale (CAPS) |
58.89; 40.22 | .028 sig |
| PRIMARY Percentage Days of Heavy Drinking |
29.01; 16.19 | .022 sig |
| PRIMARY Patient-reported PTSD Checklist |
57.72; 43.78 | .009 sig |
| PRIMARY Partner-reported PTSD Checklist |
54.89; 35.67 | .001 sig |
| SECONDARY Patient-reported Beck Depression Inventory - II (BDI-II) |
27.81; 17.62 | .043 sig |
| SECONDARY Patient-reported Dyadic Adjustment Scale |
96.12; 100.76 | .482 |
| SECONDARY Partner-reported Beck Depression Inventory - II |
12.63; 6.41 | .027 sig |
| SECONDARY Partner-reported Dyadic Adjustment Scale |
92.85; 101.49 | .177 |
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.
Data sourced from ClinicalTrials.gov (NCT00946322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.