Insomnia Treatment and Problems (the iTAP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Insomnia Severity
研究概览
简要总结
This project aims to evaluate the efficacy of insomnia treatment in improving insomnia symptoms and alcohol-related problems among heavy-drinking young adults.
详细描述
Heavy alcohol use is prevalent among young adults and results in significant physical and psychological burden. Despite wide implementation of alcohol risk reduction efforts on college campuses, rates of heavy alcohol consumption remain high, with 35% of students reporting consumption of 5+ drinks on the same occasion in the past 2 weeks. Thus, additional strategies are needed to reduce the burden of heavy alcohol use among college students. More than half of heavy-drinking college students report symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems. The proposed project aims to reduce the burden of heavy alcohol use on college campuses by examining the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) in reducing alcohol use and related problems among heavy-drinking college students. Twenty seven young adults who indicate risk for problem drinking and meet DSM-5 criteria for Insomnia Disorder will participate in a 5-week pilot trial. Participants will complete five individual sessions of CBT-I. Outcomes will be assessed at the end of the active intervention period (6 weeks) and 1 month post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity, and alcohol-related consequences. The proposed research aims to reduce the harms associated with heavy alcohol use among young adults by improving the availability of efficacious treatment. It will impact understanding of the benefits of CBT-I, and it is innovative because it evaluates improvement in insomnia as a mechanism for improvements in alcohol use disorder (AUD). This research is consistent with the National Institute on Alcohol Abuse and Alcoholism's initiative to evaluate and promote interventions that prevent the progression of AUD in diverse populations. It will enhance the stature of the university by improving our ability to compete successfully for federal funding to conduct high-quality research.
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
- Double (Participant, Outcomes Assessor)
盲法说明
PI Miller will not be blinded to block size or participant assignment because she will inform study therapists of participant assignment to conditions. However, PI Miller and study therapists will be blinded to assessment outcomes, and the assessment RA will be blinded to participant condition. All participants will be told that they will be assigned to one of two insomnia treatment conditions in order to blind them to condition assignment.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-30 years
- •Heavy episodic drinking, defined as 1 heavy drinking episode (4/5+ drinks for women/men) in the past 30 days on the Timeline Followback
- •DSM-5 criteria for insomnia, with "daytime impairment" operationalized as ISI scores =>10
排除标准
- •Unable to provide informed consent
- •New sleep medication in the past 6 weeks
- •Contraindications for CBT-I (mania or seizure disorder)
- •Severe psychiatric disorder that requires clinical attention (PTSD, major depression)
- •Current treatment for insomnia or alcohol use
结局指标
主要结局
Insomnia Severity
时间窗: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Assessed using the Insomnia Severity Index. Scores range from 0 to 28, with higher scores indicating higher insomnia severity.
Sleep Efficiency
时间窗: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Assessed using daily sleep diaries and actigraphy -- sleep efficiency is the proportion of time spent in bed (from lights out until out of bed in the morning) that is actually spent sleeping (subtracting how long it took to fall asleep and how much time was spent awake in the middle of the night).
Sleep Quality
时间窗: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Assessed using a single question on the daily sleep diary. Sleep quality score ranges from 0-4, where 0=very poor sleep quality and 4=very good sleep quality.
Drinking Quantity
时间窗: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Assessed using the Daily Drinking Questionnaire. Participants estimate how many alcoholic drinks they typically consume on each day of the week, averaged over the past 3 months.Responses for drinking quantity range from 0 to infinity, where higher numbers indicate more standard drinks consumed per day. Reports from each day are summed to create a "Drinks Per Week" score. Participants also report the amount of time they typically spend drinking during each day of the week. Responses range from 0-24 hours per day, where higher numbers indicate more hours drinking.
Alcohol-related Consequences
时间窗: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Assessed using the Brief Young Adult Alcohol Consequences Questionnaire. Scores range from 0-24, with higher scores indicating more alcohol-related consequences.
次要结局
- Delay Discounting(Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12))
- Alcohol Craving(Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12))
- Negative Affect(Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12))
- Emotion Regulation(Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12))
研究者
Mary E Miller
Professor, Psychiatry
University of Missouri-Columbia