Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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: Treatment as Usual
Behavioral: Couple-Based Treatment for Alcohol Use Disorders and PTSD
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
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 Department of Veterans Affairs:

Primary Outcome Measures:
  • Number of days drinking or using drugs [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: August 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Treatment as Usual
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
Experimental: Arm 2
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
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

Contacts
Contact: Jeremiah A Schumm, PhD (513) 861-3100 ext 6717 Jeremiah.Schumm@va.gov

Locations
United States, Ohio
VA Medical Center, Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Jeremiah A Schumm, PhD    513-861-3100 ext 6717    Jeremiah.Schumm@va.gov   
Principal Investigator: Jeremiah A. Schumm, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Jeremiah A. Schumm, PhD Cincinnati VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00946322     History of Changes
Other Study ID Numbers: CDA-2-019-09S
Study First Received: July 23, 2009
Last Updated: May 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
post-traumatic stress disorder
alcohol-related disorders
substance use disorders
couple therapy

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

ClinicalTrials.gov processed this record on November 25, 2014