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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
113
Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational "cores." Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention.
Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information "unlocking") and there are no customized bedtime or wake-time suggestions based on sleep diary data.
University Of Kentucky Psychology Research Lab
Lexington, Kentucky, United States
Change In Alcohol Use: 1) Total Number of Drinking Days (DD)
Participants reported daily alcohol use on a daily alcohol diary, including whether alcohol was consumed each day. Daily responses were used to calculate the total number of drinking days during the assessment period.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Change In Alcohol Use: 2) Average Number of Drinks Per Drinking Day (DPDD).
Participants will report the number of drinks consumed each day on a daily alcohol diary.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Change In Alcohol Use: 3) Total Number of Drinks (TD).
Participants will report the number of drinks consumed each day on a daily alcohol diary.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Change In Alcohol Use: 4) Total Number of Binge Episodes (HDD)
Participants will report the number of drinks consumed each day on a daily alcohol diary. Summary measures will include total number of binge episodes (4/5+ drinks for women/men) over a 10-day period.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
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. Higher scores on the ISI mean worse sleep (more severe insomnia).
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
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. On the PSQI, higher scores mean worse sleep quality.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
Change In Sleep: 3) Daily Sleep Diaries
Sleep Onset Latency (SOL). Participants will report how long it took them to fall asleep.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Change In Sleep: 4) Daily Sleep Diaries
Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Change in Medication Use: 5) Daily Sleep Diaries
Participants will report the amount of sleep medication used each day.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
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.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
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.
Time frame: 33 weeks (baseline, at the end of the 9-week intervention, at 3- and 6-months post-intervention)
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