Testing an Online Insomnia Intervention to Reduce Alcohol Use Via Improved Sleep Among Heavy Drinkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change In Sleep: Insomnia Severity Index (ISI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SHUTi Intervention
Adult heavy drinkers with insomnia
干预措施: SHUTi Intervention (Behavioral)
Web-Based Insomnia Education Program
Adult heavy drinkers with insomnia
干预措施: Web-Based Insomnia Education Program (Behavioral)
结局指标
主要结局
Change In Sleep: Insomnia Severity Index (ISI)
时间窗: 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. Higher scores on the ISI mean worse sleep (more severe insomnia).
Change In Sleep: 2) Pittsburgh Sleep Quality Index (PSQI)
时间窗: 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. On the PSQI, higher scores mean worse sleep quality.
Change In Alcohol Use: 1) Total Number of Drinking Days (DD)
时间窗: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
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.
Change In Alcohol Use: 2) Average Number of Drinks Per Drinking Day (DPDD).
时间窗: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Participants will report the number of drinks consumed each day on a daily alcohol diary.
Change In Alcohol Use: 3) Total Number of Drinks (TD).
时间窗: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Participants will report the number of drinks consumed each day on a daily alcohol diary.
Change In Alcohol Use: 4) Total Number of Binge Episodes (HDD)
时间窗: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
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.
Change In Sleep: 3) Daily Sleep Diaries
时间窗: 33 weeks (baseline, at the end of the 9-week intervention, 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
时间窗: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Wake after Sleep Onset (WASO): Participants will report the number of minutes awake after falling asleep.
Change in Medication Use: 5) Daily Sleep Diaries
时间窗: 33 weeks (baseline, at the end of the 9-week intervention, and 6-months post-intervention)
Participants will report the amount of sleep medication used each day.
次要结局
- 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))
- 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))
研究者
Jessica Weafer
Associate Professor
Ohio State University