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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

July 23, 2009
January 12, 2016
August 2010
December 2014   (final data collection date for primary outcome measure)
  • 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.
Number of days drinking or using drugs [ Time Frame: 11 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00946322 on ClinicalTrials.gov Archive Site
  • 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.
  • Problems related drinking or using drugs [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • Post-traumatic stress disorder [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • Couple relationship adjustment [ Time Frame: 11 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Couple-Based Treatment for Alcohol Use Disorders and Post-Traumatic Stress Disorder
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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alcohol-related Disorders
  • Post-traumatic Stress Disorder
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
Experimental: Arm 1: CTAP
Couple-Based Treatment for Alcohol Use Disorders and PTSD
Intervention: Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
February 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00946322
CDA-2-019-09S
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Jeremiah A. Schumm, PhD Cincinnati VA Medical Center, Cincinnati, OH
VA Office of Research and Development
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP