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Completed

NCT Number: NCT00946322

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Couple-Based Treatment for Alcohol Use Disorders and PTSD

Behavioral

This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.

Other names: CTAP

Primary outcomes

  1. Clinician-administered PTSD Scale (CAPS)

    Time frame: Pre- to post-treatment (~20 weeks)

    Total severity score on the CAPS was used. Higher = worse outcome. Possible range of scores 0-135.

  2. Percentage Days of Heavy Drinking

    Time frame: Pre- to post-treatment (~20 weeks)

    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.

  3. Patient-reported PTSD Checklist

    Time frame: Pre- to post-treatment (~20 weeks)

    Patient self-reported total severity score on the PTSD Checklist - Specific (PCL-S) version. Possible range of scores 17-85. Higher = worse.

  4. Partner-reported PTSD Checklist

    Time frame: Pre- to post-treatment (~20 weeks)

    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 outcomes

  1. Patient-reported Beck Depression Inventory - II (BDI-II)

    Time frame: Pre- to post-treatment

    Patient-reported total severity score on Beck Depression Inventory - II (BDI-II). Possible range 0-63. Higher = worse.

  2. Patient-reported Dyadic Adjustment Scale

    Time frame: Pre- to post-treatment (~20 weeks)

    Patient-reported total score on the Dyadic Adjustment Scale (DAS), which is a measure of couple relationship satisfaction. Possible range = 0 - 151. Higher = worse.

  3. Partner-reported Beck Depression Inventory - II

    Time frame: Pre- to post-treatment (~20 weeks)

    Partner-reported Beck Depression Inventory - II (BDI-II) total severity score. Possible range 0-63. Higher = worse.

  4. Partner-reported Dyadic Adjustment Scale

    Time frame: Pre- to post-treatment (~20 weeks)

    Partner-reported total score on the Dyadic Adjustment Scale, which is a measure of couple relationship satisfaction. Possible range 0-151. Higher = worse.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Couple-Based Treatment for Alcohol Use Disorders and PTSD

Acronym: CTAP

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jul 27, 2009
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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