search
Back to results

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

Primary Purpose

Alcohol-related Disorders, Post-traumatic Stress Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Couple-Based Treatment for Alcohol Use Disorders and PTSD
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-related Disorders focused on measuring post-traumatic stress disorder, alcohol-related disorders, substance use disorders, couple therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cincinnati VA Medical Center, Cincinnati, OH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1: CTAP

Arm Description

Couple-Based Treatment for Alcohol Use Disorders and PTSD

Outcomes

Primary Outcome Measures

Clinician-administered PTSD Scale (CAPS)
Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.
Percentage Days of Heavy Drinking
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
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
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)
Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.
Patient-reported Dyadic Adjustment Scale
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
Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.
Partner-reported Dyadic Adjustment Scale
Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.

Full Information

First Posted
July 23, 2009
Last Updated
January 12, 2016
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT00946322
Brief Title
Couple-Based Treatment for Alcohol Use Disorders and Post-Traumatic Stress Disorder
Acronym
CTAP
Official Title
Couple-Based Treatment for Alcohol Use Disorders and PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-related Disorders, Post-traumatic Stress Disorder
Keywords
post-traumatic stress disorder, alcohol-related disorders, substance use disorders, couple therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: CTAP
Arm Type
Experimental
Arm Description
Couple-Based Treatment for Alcohol Use Disorders and PTSD
Intervention Type
Behavioral
Intervention Name(s)
Couple-Based Treatment for Alcohol Use Disorders and PTSD
Other Intervention Name(s)
CTAP
Intervention Description
This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
Primary Outcome Measure Information:
Title
Clinician-administered PTSD Scale (CAPS)
Description
Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.
Time Frame
Pre- to post-treatment (~20 weeks)
Title
Percentage Days of Heavy Drinking
Description
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.
Time Frame
Pre- to post-treatment (~20 weeks)
Title
Patient-reported PTSD Checklist
Description
Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.
Time Frame
Pre- to post-treatment (~20 weeks)
Title
Partner-reported PTSD Checklist
Description
Partner-reported total severity score for patient's PTSD symptoms on the PTSD Checklist - Specific (PCL-S) version. Possible range 17-85. Higher = worse.
Time Frame
Pre- to post-treatment (~20 weeks)
Secondary Outcome Measure Information:
Title
Patient-reported Beck Depression Inventory - II (BDI-II)
Description
Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.
Time Frame
Pre- to post-treatment
Title
Patient-reported Dyadic Adjustment Scale
Description
Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.
Time Frame
Pre- to post-treatment (~20 weeks)
Title
Partner-reported Beck Depression Inventory - II
Description
Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.
Time Frame
Pre- to post-treatment (~20 weeks)
Title
Partner-reported Dyadic Adjustment Scale
Description
Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.
Time Frame
Pre- to post-treatment (~20 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremiah A. Schumm, PhD
Organizational Affiliation
Cincinnati VA Medical Center, Cincinnati, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati VA Medical Center, Cincinnati, OH
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs