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

NCT00946322 | Completed Phase 1 Results

• 1 other identifier: CDA-2-019-09S
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol-related Disorders; Post-traumatic Stress Disorder

Keywords

post-traumatic stress disorder; alcohol-related disorders; substance use disorders; couple therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Patient-reported Beck Depression Inventory - II (BDI-II)

  Pre- to post-treatment

• Patient-reported Dyadic Adjustment Scale

  Pre- to post-treatment (~20 weeks)

• Partner-reported Beck Depression Inventory - II

  Pre- to post-treatment (~20 weeks)

• Partner-reported Dyadic Adjustment Scale

  Pre- to post-treatment (~20 weeks)

Study Arms (1)

Arm 1: CTAP

EXPERIMENTAL

Couple-Based Treatment for Alcohol Use Disorders and PTSD

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

Interventions

Couple-Based Treatment for Alcohol Use Disorders and PTSD BEHAVIORAL

This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.

Also known as: CTAP

Arm 1: CTAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Alcohol-Related Disorders; Stress Disorders, Post-Traumatic; Substance-Related Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Limitations and Caveats

Study was an initial open-trial pilot study. A causal relationship cannot be determined between study interventions and outcomes due to lack of a comparison condition.

Results Point of Contact

• Title: Jeremiah A. Schumm, PhD, Associate Director
• Organization: Trauma Recovery Center, Cincinnati VA Medical Center

Jeremiah.Schumm@va.gov

859-572-6717

Study Officials

• Jeremiah A. Schumm, PhD

  Cincinnati VA Medical Center, Cincinnati, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 27, 2009
• Study Start: August 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: February 8, 2016
• Results First Posted: January 13, 2016

Record last verified: 2016-01

Locations

US (1)