Insomnia Treatment and Problems (the iTAP Study) (iTAP)

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

Study Overview

• Status: Completed
• Conditions: Alcohol; Harmful Use; Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I); Behavioral: Sleep Hygiene

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CBT-I; Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for 6 weeks	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.
ACTIVE_COMPARATOR: Sleep Hygiene; Sleep hygiene handout delivered once to all participants	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity	Assessed using the Insomnia Severity Index. Scores range from 0 to 28, with higher scores indicating higher insomnia severity.	Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Sleep Efficiency	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).	Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Sleep Quality	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.	Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Drinking Quantity	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.	Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Alcohol-related Consequences	Assessed using the Brief Young Adult Alcohol Consequences Questionnaire. Scores range from 0-24, with higher scores indicating more alcohol-related consequences.	Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay Discounting	Assessed using the Monetary Choice Questionnaire. Responses will be used to calculate discount rate (k), consistency of the discount rate (the inferred k), and the proportion of immediate reward choices (immediate choice ratios).	Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Negative Affect	Assessed using the Positive and Negative Affect Schedule. Participants respond to words that describe negative feelings/emotions and report the extent (1-5) that they feel each emotion presently or during the past week. Higher scores indicate higher negative affect.	Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Emotion Regulation	Assessed using the Difficulties with Emotion Regulation Scale. Scores range from 36-180, with higher scores indicating more difficulty with emotion regulation.	Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Alcohol Craving	Assessed using the Penn Alcohol Craving Scale. Scores range from 0-30, with higher scores indicating greater alcohol craving.	Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Publications and helpful links

General Publications

• Miller MB, Carpenter RW, Freeman LK, Curtis AF, Yurasek AM, McCrae CS. Cannabis use as a moderator of cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2022 Apr 1;18(4):1047-1054. doi: 10.5664/jcsm.9796.
• Miller MB, Curtis AF, Hall NA, Freeman LK, Everson AT, Martinez LD, Park CJ, McCrae CS. Daily associations between modifiable sleep behaviors and nighttime sleep among young adult drinkers with insomnia. J Clin Sleep Med. 2022 Mar 1;18(3):703-712. doi: 10.5664/jcsm.9706.
• Miller MB, Freeman LK, Deroche CB, Park CJ, Hall NA, McCrae CS. Sleep and alcohol use among young adult drinkers with Insomnia: A daily process model. Addict Behav. 2021 Aug;119:106911. doi: 10.1016/j.addbeh.2021.106911. Epub 2021 Mar 15.
• Miller MB, Deroche CB, Freeman LK, Park CJ, Hall NA, Sahota PK, McCrae CS. Cognitive behavioral therapy for insomnia among young adults who are actively drinking: a randomized pilot trial. Sleep. 2021 Feb 12;44(2):zsaa171. doi: 10.1093/sleep/zsaa171.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 29, 2018
• Primary Completion (ACTUAL): September 27, 2019
• Study Completion (ACTUAL): September 27, 2019

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (ACTUAL): August 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: sleep; young adult; insomnia; alcohol; drinking
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2010684; DXV15 (OTHER_GRANT: University of Missouri Research Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No