NCT03627832

Insomnia Treatment and Problems (the iTAP Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This project aims to evaluate the efficacy of insomnia treatment in improving insomnia symptoms and alcohol-related problems among heavy-drinking young adults.

Detailed description

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.

Conditions

• Insomnia
• Alcohol; Harmful Use

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia (CBT-I)	Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, \& Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
BEHAVIORAL	Sleep Hygiene	All participants will receive a one-page handout on sleep hygiene. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.

Timeline

• Start date: 2018-08-29
• Primary completion: 2019-09-27
• Completion: 2019-09-27
• First posted: 2018-08-13
• Last updated: 2020-06-16
• Results posted: 2020-06-04

Locations

1 site across 1 country: United States