Alcohol Use Disorder Clinical Trial
Official title:
Testing an Online Insomnia Intervention to Reduce Alcohol Use Via Improved Sleep Among Heavy Drinkers
Alcohol use disorder (AUD) inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Insomnia is highly prevalent among individuals with AUD, and disrupted sleep contributes substantially to alcohol-related problems. While research suggests that treating insomnia may effectively reduce AUD, the degree to which treating insomnia in heavy drinkers reduces alcohol consumption and prevents the onset of severe AUD is not known. This study will be the first to evaluate an Internet-based version of cognitive behavioral therapy for insomnia (CBT-I) in community-dwelling, heavy drinking adults with insomnia. Sleep Healthy Using the Internet (SHUTi), the most widely-used and well-validated version of Internet-based CBT-I will be used. The primary aim is to reduce alcohol consumption and insomnia severity in this population.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - 18-50 years old - Fluency in English - At least weekly binge drinking episodes (4/5+ drinks for women/men)] - Insomnia Severity Index (ISI) scores #15 Exclusion Criteria: - No internet access - Past or current substance use disorder (other than mild or moderate AUD) - Obstructive sleep apnea - Bipolar disorder, schizophrenia, or other psychotic spectrum disorder - Pregnancy or nursing for women - Any serious medical or neurological problems |
Country | Name | City | State |
---|---|---|---|
United States | University Of Kentucky Psychology Research Lab | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Jessica Weafer | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change In Alcohol Use: Daily Alcohol Diaries | Participants will report the number of drinks consumed each day and proximity of alcoholic drinks to bedtime. Summary measures will include total number of drinking days, total number of drinks, average number of drinks per drinking day, and total number of binge episodes (4/5+ drinks for women/men) over a 10-day period. | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | |
Primary | Change In Sleep: Insomnia Severity Index (ISI) | The ISI uses a 7-item scale to asses insomnia impact over the previous two weeks. Items scores range from 0-28. Scores indicate moderate to severe insomnia. Moderate or marked clinical improvement is indicated by a change score of >7 or >8 respectively. | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | |
Primary | Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI) | The PSQI indexes one-month global sleep quality using 18 items scored on a scale from 0-21. Scores # 5 indicate poor sleep quality. | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | |
Primary | Change In Sleep: 3) Daily Sleep Diaries | Sleep Onset Latency (SOL). Participants will report how long it took them to fall asleep. | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | |
Primary | Change In Sleep: 4) Daily Sleep Diaries | Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep. | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | |
Primary | Change in Medication Use: 5) Daily Sleep Diaries | Participants will report the amount of sleep medication used each day. | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | |
Secondary | Change In Mood: 1) Perceived Stress Scale (PSS) | The PSS will assess perceived stress over the prior month. Scores range from 0-40. The PSS demonstrates strong concurrent and predictive validity for various health behaviors and outcomes with higher scores indicating greater psychological distress. | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) | |
Secondary | Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10) | The CESD-R-10 will index past-week depressive symptoms. Scores range from 0-30. Higher scores represent more severe symptoms. | 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) |
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