The iTAP Study for Veterans

NCT03804788 | Completed Results DMC

• 2 other identifiers: 2014239K23AA026895
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.

Conditions

Insomnia; Alcohol; Harmful Use

Keywords

alcohol; drinking; sleep; insomnia; veteran

Outcome Measures

Primary Outcomes (8)

• Recruitment

  Number of eligible participants who enrolled in the study

  Assessed at baseline

• Retention

  Number of participants who complete all treatment sessions

  Assessed at post-treatment (week 6)

• Drinking Quantity

  Assessed using Daily Drinking Questionnaire. Participants report the number of standard drinks consumed on each day of a typical week in the past month (on Monday, Tuesday, Wednesday, etc). Responses for each day are then summed to calculate a total "drinks per week" variable, where higher scores indicate more standard drinks.

  Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

• Alcohol-related Consequences

  Assessed using the Brief Young Adult Alcohol Consequences Questionnaire, which asks participants to indicate (yes/no) which of 24 consequences they have experienced in the past month. Responses range from 0 to 24, with greater scores indicating more consequences.

  Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

• Insomnia Symptoms

  Assessed using Insomnia Severity Index (ISI). ISI scores from 0 to 28, with higher scores indicating more severe insomnia.

  Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

• Sleep Quality

  On daily sleep diaries, participants reported sleep quality on a scale from 0 (very poor) to 4 (very good). Higher scores indicate better sleep quality.

  Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

• Sleep Efficiency

  Daily sleep diaries were used to calculate the amount of time that participants spent sleeping out of all the time they spent in bed. Values from 0 to 100, with higher scores indicating better sleep efficiency. The treatment goal is 85%.

  Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

• Client Satisfaction

  Assessed using the 8-item Client Satisfaction Questionnaire. Participants rate their satisfaction with insomnia treatment on a scale from 1 (poor) to 4 (excellent). Scores were summed and then divided by the number of items to create a meaningful standardized score. Higher scores indicate greater satisfaction.

  Mean score at post-treatment (week 6).

Secondary Outcomes (6)

• Delay Discounting

  Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

• Negative Affect

  Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

• Emotion Regulation

  Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

• Alcohol Craving

  Primary analyses will measure between-group change in at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

• Percentage of Days Using Alcohol to Help With Sleep

  Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.

Study Arms (2)

CBT-I

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Hygeine

Sleep Hygiene

ACTIVE COMPARATOR

Sleep hygiene handout delivered once to all participants.

Behavioral: Sleep Hygeine

Interventions

Cognitive Behavioral Therapy for Insomnia 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. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). 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.

Also known as: (CBT-I)

CBT-I

Sleep Hygeine BEHAVIORAL

All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. 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+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran deployed for military service after September 11, 2001
• + heavy drinking episode (4/5+ drinks in 2 hours for women/men) in past 30 days
• DSM-5 and research diagnostic criteria for Insomnia Disorder

You may not qualify if:

• Inability to provide informed consent
• Cognitive impairment
• Contraindications for CBT-I (mania or seizure disorder)
• Untreated sleep disorder requiring more than behavioral treatment for insomnia
• Engagement in overnight shift work at baseline
• Care of a child under 1 year of age
• Severe or untreated psychiatric disorder that requires immediate clinical attention
• Current behavioral treatment for insomnia or alcohol use
• Initiation of sleep medication in the past 6 weeks

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

• Miller MB, Carpenter RW, Shoemaker SD, Moskal KR, Borsari B, Pedersen ER, Bartholow BD, Steinley D, McCrae CS. Cognitive behavioral therapy for insomnia among heavy-drinking veterans: a randomized pilot trial. Sleep Adv. 2025 Jun 10;6(2):zpaf037. doi: 10.1093/sleepadvances/zpaf037. eCollection 2025 Apr.

  PMID: 40575624 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

Limitations and Caveats

The COVID-19 pandemic changed the way people drink and required modifications to the protocol. Most treatment sessions were conducted via telehealth. As a result, all data were collected via self-report. Finally, data were collected from a relatively small, homogeneous sample of heavy-drinking Veterans. The control condition was not matched with CBT-I for time and content, so we cannot determine from this trial whether improvements are due to CBT-I or non-specific therapy effects.

Results Point of Contact

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

millmary@health.missouri.edu

573-882-1813

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 be blind to participant assignment because the project manager will inform study therapists of participant assignment to conditions. PI Miller and study therapists will be blinded to assessment outcomes, and assessment RAs will be blinded to participant condition. All participants will be told that they are receiving treatment for insomnia in order to blind them to condition assignment (sleep hygiene will be described as "brief" insomnia treatment, and CBT-I will be described as the "most intense" treatment).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry

Model Details: Subjects will be randomized to receive sleep hygiene or to participate in sessions of individual Cognitive Behavioral Therapy for Insomnia (CBT-I).

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 15, 2019
• Study Start: April 4, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2024-12

Locations

US (1)