Insomnia Treatment and Problems (the iTAP Study)

University of Missouri (MU) logo

University of Missouri (MU)

Status

Completed

Conditions

Alcohol; Harmful Use
Insomnia

Treatments

Behavioral: Sleep Hygiene
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type

Interventional

Funder types

Other

Identifiers

NCT03627832
DXV15 (Other Grant/Funding Number)
2010684

Details and patient eligibility

About

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

Full 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.

Enrollment

56 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 2 patient groups

CBT-I
Experimental group
Description:
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for 6 weeks
Treatment:
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral: Sleep Hygiene
Sleep Hygiene
Active Comparator group
Description:
Sleep hygiene handout delivered once to all participants
Treatment:
Behavioral: Sleep Hygiene

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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