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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Couple-Based Treatment for Alcohol Use Disorders and PTSD

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.

Detailed Summary:
Sponsor: VA Office of Research and Development

Current Primary Outcome:

• 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.
• 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.
• 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.
• 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.

Original Primary Outcome: Number of days drinking or using drugs [ Time Frame: 11 months ]

Current Secondary Outcome:

• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome:

• Problems related drinking or using drugs [ Time Frame: 11 months ]
• Post-traumatic stress disorder [ Time Frame: 11 months ]
• Couple relationship adjustment [ Time Frame: 11 months ]

Dates:
Date Received: July 23, 2009
Date Started: August 2010
Date Completion:
Last Updated: January 12, 2016
Last Verified: January 2016