Columbia, Missouri 65212

  • Alcohol; Harmful Use

Purpose:

This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.


Study summary:

More than half of returning Veterans who screen positive for hazardous drinking report clinically significant symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems, perhaps due to insomnia-related impairments in executive functioning, negative emotionality, and craving. The proposed project aims to examine improvements in insomnia as a mechanism for improvement in alcohol use among heavy-drinking Veterans with insomnia. Forty-four returning Veterans who report heavy drinking (≥4/5 drinks per occasion for women/men) and have insomnia based on DSM-5 and research diagnostic criteria will participate in a randomized pilot trial. Participants will be randomly assigned to receive personalized normative alcohol feedback in the context of one of two treatment conditions: CBT-I (n = 22) or a sleep hygiene education control (SH; n = 22). Outcomes will be assessed at the end of the active intervention period (6 weeks), mid-treatment (after 3 sessions), and at 3 months post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity/frequency, alcohol-related consequences, executive functioning, negative affect, emotion regulation, craving for alcohol, and use of alcohol as a sleep aid.


Criteria:

Inclusion criteria: - Veteran deployed for military service after September 11, 2001 - 1+ heavy drinking episode (4/5+ drinks in 2 hours for women/men) in past 30 days - DSM-5 and research diagnostic criteria for Insomnia Disorder Exclusion Criteria: - Inability to provide informed consent - Cognitive impairment - Contraindications for CBT-I (mania or seizure disorder) - Untreated sleep disorder requiring more than behavioral treatment for insomnia - Engagement in overnight shift work at baseline - Care of a child under 1 year of age - Severe or untreated psychiatric disorder that requires immediate clinical attention - Current behavioral treatment for insomnia or alcohol use - Initiation of sleep medication in the past 6 weeks


NCT ID:

NCT03804788


Primary Contact:

N/A


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

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