Online Insomnia Intervention to Reduce Alcohol Use
- Conditions
- Alcohol Use DisorderHeavy Drinking
- Interventions
- Behavioral: SHUTi InterventionBehavioral: Web-Based Insomnia Education Program
- Registration Number
- NCT05630118
- Lead Sponsor
- Jessica Weafer
- Brief Summary
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.
- Detailed Description
The study will investigate the efficacy of Sleep Healthy Using the Internet (SHUTi), an online insomnia intervention, in reducing alcohol consumption and improving sleep in heavy drinkers with insomnia. The participants are ages 18-50 (N=100) who have insomnia and are heavy drinkers (at least weekly binge drinking episodes \[4/5+ drinks in one sitting for men/women\]). This intervention has a mixed methods randomized controlled trial design. Participants will be randomly assigned to either the online SHUTi intervention (N=50), or a patient education (PE) website (N=50). Quantitative data will be collected via online REDCap surveys and daily online diaries. Qualitative data will be collected via semi-structured telephone interviews. Data collection points will be pre-intervention, post-intervention, and 3- and 6-months postintervention.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 113
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHUTi Intervention SHUTi Intervention Adult heavy drinkers with insomnia Web-Based Insomnia Education Program Web-Based Insomnia Education Program Adult heavy drinkers with insomnia
- Primary Outcome Measures
Name Time Method Change In Sleep: 3) Daily Sleep Diaries 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) Sleep Onset Latency (SOL). Participants will report how long it took them to fall asleep.
Change In Sleep: 4) Daily Sleep Diaries 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep.
Change In Alcohol Use: Daily Alcohol Diaries 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) 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.
Change In Sleep: Insomnia Severity Index (ISI) 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) 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.
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI) 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) The PSQI indexes one-month global sleep quality using 18 items scored on a scale from 0-21. Scores # 5 indicate poor sleep quality.
Change in Medication Use: 5) Daily Sleep Diaries 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) Participants will report the amount of sleep medication used each day.
- Secondary Outcome Measures
Name Time Method Change In Mood: 1) Perceived Stress Scale (PSS) 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) 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.
Change In Mood: 2) Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10) 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention) The CESD-R-10 will index past-week depressive symptoms. Scores range from 0-30. Higher scores represent more severe symptoms.
Trial Locations
- Locations (1)
University Of Kentucky Psychology Research Lab
🇺🇸Lexington, Kentucky, United States