Clinical trial NCT03627832: Insomnia Treatment and Problems (the iTAP Study)
Official title: Insomnia Treatment and Problems (the iTAP Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Alcohol; Harmful Use
Keywords: alcohol
drinking
sleep
insomnia
young adult
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to receive either Cognitive Behavioral Therapy for Insomnia (CBT-I) or Sleep Hygiene.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity
timeFrame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
measure: Sleep Efficiency
timeFrame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
measure: Sleep Quality
timeFrame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
measure: Drinking Quantity
timeFrame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
measure: Alcohol-related Consequences
timeFrame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Secondary outcomes:
measure: Delay Discounting
timeFrame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
measure: Negative Affect
timeFrame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
measure: Emotion Regulation
timeFrame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
measure: Alcohol Craving
timeFrame: Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Mary Beth Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.