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

January 12, 2016 updated by: VA Office of Research and Development

Couple-Based Treatment for Alcohol Use Disorders and PTSD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati VA Medical Center, Cincinnati, OH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician-administered PTSD Scale (CAPS)
Time Frame: Pre- to post-treatment (~20 weeks)
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
Time Frame: 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.
Pre- to post-treatment (~20 weeks)
Patient-reported PTSD Checklist
Time Frame: 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.
Pre- to post-treatment (~20 weeks)
Partner-reported PTSD Checklist
Time Frame: 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.
Pre- to post-treatment (~20 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported Beck Depression Inventory - II (BDI-II)
Time Frame: Pre- to post-treatment
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
Time Frame: 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.
Pre- to post-treatment (~20 weeks)
Partner-reported Beck Depression Inventory - II
Time Frame: Pre- to post-treatment (~20 weeks)
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
Time Frame: 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.
Pre- to post-treatment (~20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Jeremiah A. Schumm, PhD, Cincinnati VA Medical Center, Cincinnati, OH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 27, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDA-2-019-09S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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