The iTAP Study for Veterans

NCT ID: NCT03804788

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2023-09-30

Brief Summary

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

Detailed Description

More than half of returning Veterans who screen positive for hazardous drinking report clinically significant symptoms of insomnia. In turn, insomnia symptoms have been associated with increased risk of alcohol-related problems, perhaps due to insomnia-related impairments in executive functioning, negative emotionality, and craving. The proposed project aims to examine improvements in insomnia as a mechanism for improvement in alcohol use among heavy-drinking Veterans with insomnia. Forty-four returning Veterans who report heavy drinking (≥4/5 drinks per occasion for women/men) and have insomnia based on DSM-5 and research diagnostic criteria will participate in a randomized pilot trial. Participants will be randomly assigned to receive personalized normative alcohol feedback in the context of one of two treatment conditions: CBT-I (n = 22) or a sleep hygiene education control (SH; n = 22). Outcomes will be assessed at the end of the active intervention period (6 weeks), mid-treatment (after 3 sessions), and at 3 months post-intervention. Outcomes of interest include insomnia severity, total wake time, sleep quality, drinking quantity/frequency, alcohol-related consequences, executive functioning, negative affect, emotion regulation, craving for alcohol, and use of alcohol as a sleep aid.

Conditions

Insomnia; Alcohol; Harmful Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-I

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

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type: 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.

Sleep Hygeine

Intervention Type: 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.

Sleep Hygiene

Sleep hygiene handout delivered once to all participants.

Group Type: ACTIVE_COMPARATOR

Sleep Hygeine

Intervention Type: 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.

Interventions

Cognitive Behavioral Therapy for Insomnia

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.

Intervention Type: BEHAVIORAL

Sleep Hygeine

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

(CBT-I)

Eligibility Criteria

Inclusion Criteria

• Veteran deployed for military service after September 11, 2001
• 1+ 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Mary E Miller

Professor, Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Missouri-Columbia

Columbia, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40575624 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23AA026895

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2014239

Identifier Type: -

Identifier Source: org_study_id