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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00946322
First received: July 23, 2009
Last updated: May 28, 2014
Last verified: May 2014

July 23, 2009
May 28, 2014
August 2010
December 2014   (final data collection date for primary outcome measure)
Number of days drinking or using drugs [ Time Frame: 11 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00946322 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Number of heavy days drinking or using drugs [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • 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
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Alcohol-related Disorders
  • Post-traumatic Stress Disorder
  • Behavioral: Treatment as Usual
    Treatment as usual includes any psychotherapeutic intervention that the veteran would like to receive outside of the study but that is not being provided as part of the study.
    Other Name: TAU
  • 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
  • Active Comparator: Arm 1
    Treatment as Usual
    Intervention: Behavioral: Treatment as Usual
  • Experimental: Arm 2
    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.
 
Recruiting
100
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
No
Contact: Jeremiah A Schumm, PhD (513) 861-3100 ext 6717 Jeremiah.Schumm@va.gov
United States
 
NCT00946322
CDA-2-019-09S
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Jeremiah A. Schumm, PhD Cincinnati VA Medical Center
Department of Veterans Affairs
May 2014

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