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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00946322
First received: July 23, 2009
Last updated: January 12, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention Phase
Alcohol-related Disorders
Post-traumatic Stress Disorder
Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Couple-Based Treatment for Alcohol Use Disorders and PTSD

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Clinician-administered PTSD Scale (CAPS) [ Time Frame: Pre- to post-treatment (~20 weeks) ] [ Designated as safety issue: No ]
    Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.

  • Percentage Days of Heavy Drinking [ Time Frame: Pre- to post-treatment (~20 weeks) ] [ Designated as safety issue: No ]
    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.

  • Patient-reported PTSD Checklist [ Time Frame: Pre- to post-treatment (~20 weeks) ] [ Designated as safety issue: No ]
    Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.

  • Partner-reported PTSD Checklist [ Time Frame: Pre- to post-treatment (~20 weeks) ] [ Designated as safety issue: No ]
    Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.


Secondary Outcome Measures:
  • Patient-reported Beck Depression Inventory - II (BDI-II) [ Time Frame: Pre- to post-treatment ] [ Designated as safety issue: No ]
    Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.

  • Patient-reported Dyadic Adjustment Scale [ Time Frame: Pre- to post-treatment (~20 weeks) ] [ Designated as safety issue: No ]
    Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.

  • Partner-reported Beck Depression Inventory - II [ Time Frame: Pre- to post-treatment (~20 weeks) ] [ Designated as safety issue: No ]
    Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.

  • Partner-reported Dyadic Adjustment Scale [ Time Frame: Pre- to post-treatment (~20 weeks) ] [ Designated as safety issue: No ]
    Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.


Enrollment: 13
Study Start Date: August 2010
Study Completion Date: February 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CTAP

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946322

Locations
United States, Ohio
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Jeremiah A. Schumm, PhD Cincinnati VA Medical Center, Cincinnati, OH
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00946322     History of Changes
Other Study ID Numbers: CDA-2-019-09S 
Study First Received: July 23, 2009
Results First Received: December 8, 2015
Last Updated: January 12, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
post-traumatic stress disorder
alcohol-related disorders
substance use disorders
couple therapy

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Alcohol-Related Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016