Insomnia Treatment and Problems (the iTAP Study)

NCT03627832 | Completed Results

• 2 other identifiers: 2010684DXV15
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Alcohol; Harmful Use

Keywords

alcohol; drinking; sleep; insomnia; young adult

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Delay Discounting

  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)

• Alcohol Craving

  Change from baseline to post-treatment (week 8) to 1 month follow-up (week 12)

Study Arms (2)

CBT-I

EXPERIMENTAL

Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for 6 weeks

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

Sleep Hygiene

ACTIVE COMPARATOR

Sleep hygiene handout delivered once to all participants

Behavioral: Sleep Hygiene

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I) BEHAVIORAL

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.

CBT-I

Sleep Hygiene BEHAVIORAL

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.

CBT-I; Sleep Hygiene

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

Related Publications (4)

• 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.

  PMID: 34870584 DERIVED

• 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.

  PMID: 34605392 DERIVED

• 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.

  PMID: 33773200 DERIVED

• 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.

  PMID: 32886778 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Mary Beth Miller
• Organization: University of Missouri

millmary@health.missouri.edu

573-882-1813

Study Officials

• Mary Beth Miller, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry

Model Details: Participants will be assigned to receive either Cognitive Behavioral Therapy for Insomnia (CBT-I) or Sleep Hygiene.

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 13, 2018
• Study Start: August 29, 2018
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: June 16, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-06

Locations

US (1)