Columbia, Missouri 65212

  • Alcohol Use Disorder

Purpose:

Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to alcohol treatment of Veterans.


Study summary:

Alcohol use disorders (AUDs) are prevalent among Veterans and result in significant physical and psychological burden. Among those who receive treatment for AUDs, 1 in 3 relapses to problematic drinking within one year of treatment. Thus, additional strategies are needed to enhance alcohol treatment outcomes. One promising approach involves providing concurrent treatment for a common complaint - difficulty falling or staying asleep. Up to 74% of Veterans seeking treatment for AUD report co-occurring symptoms of insomnia. Given the negative impact of insomnia on attention and emotion regulation, insomnia symptoms may decrease patients' abilities to attend to alcohol treatment and manage negative emotions that lead to craving and relapse. Moreover, approximately 50% of individuals with AUDs report using alcohol to help them sleep, making relapse more likely for those with no other tools or skills to help them sleep. Indeed, sleep disturbance has been identified as a risk factor for relapse among individuals in alcohol treatment. Thus, effective treatment of sleep problems may enhance alcohol treatment. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been effective in reducing insomnia severity in individuals with AUDs; however, no investigations have examined the efficacy of CBT-I delivered concurrently with AUD treatment to determine its impact on treatment outcomes. This R21 aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to ongoing alcohol treatment. A randomized pilot trial with 80 Veterans who meet diagnostic criteria for AUD and Insomnia Disorder will be conducted. Participants will be randomly assigned to receive Cognitive Behavioral Therapy for Insomnia (CBT-I) or minimal treatment (educational handout only; EDU) in addition to alcohol treatment as usual. Outcomes will be assessed at the end of the active intervention period (6 weeks) and 6 weeks post-intervention. Preliminary process outcomes include recruitment/retention rates and treatment satisfaction (feasibility and acceptability, respectively). Primary outcomes are insomnia severity, percentage of heavy drinking days, and alcohol-related problems; and we plan to examine post-treatment changes in insomnia severity as a mediator of treatment effects on alcohol use outcomes. We will also assess treatment effects on a variety of secondary clinical and mechanistic outcomes (e.g., PTSD symptoms, attention, working memory, treatment-related learning). Multiple imputation will be used for missing data, and analyses will be intent-to-treat.


Criteria:

Inclusion Criteria: - Participation in alcohol treatment at the Truman VA (Columbia, MO) - DSM-5 criteria for moderate to severe Alcohol Use Disorder - Substance use in the past 2 months - DSM-5 episodic criterion (duration at least 1 month) for Insomnia Disorder Exclusion Criteria: - unable to provide informed consent - cognitive impairment - continuous sobriety for 2+ months at baseline - manic episode or seizure in the past year (contraindications for CBT-I) - severe psychiatric disorder that requires immediate clinical attention - initiation of a sleep medication in the past six (6) weeks


NCT ID:

NCT03806491


Primary Contact:

Principal Investigator
Mary Beth Miller, PhD
University of Missouri-Columbia

Mary Beth Miller, PhD
Phone: 573-882-1813
Email: millmary@health.missouri.edu


Backup Contact:

N/A


Location Contact:

Columbia, Missouri 65212
United States

Mary Beth Miller, PhD
Phone: 573-882-1813
Email: millmary@health.missouri.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.