The iTAP Study for Veterans (iTAP-V)

The Impact of Insomnia Treatment on Heavy Alcohol Use Among Returning Veterans

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

Study Overview

• Status: Completed
• Conditions: Alcohol; Harmful Use; Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Hygeine

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• 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 and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• 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 six (6) weeks.	Behavioral: 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.; Other Names: (CBT-I); 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.
Active Comparator: Sleep Hygiene; Sleep hygiene handout delivered once to all participants.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay Discounting	Assessed using the Monetary Choice Questionnaire (MCQ). Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days). The MCQ is scored using a logarithmic subject-specific discount rate (k variable). K values typically fall between 0.0 and 0.5, with higher values indicating a preference for smaller, immediate rewards over larger, delayed reward ("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	Assessed using the Positive and Negative Affect Schedule. Participants indicate using a 1 (not at all) - 5 (extremely) scale to indicate to what extent they feel negative emotions. The final score is the sum of the ten negative emotions/feelings. Higher scores indicate more 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	Assessed using the Difficulties in Emotion Regulation Scale (DERS-16). Scores range from 0 to 64, with higher scores indicating more difficulties with 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	Assessed using the Penn Alcohol Craving Scale (PACS). Scores range from 0 to 30, with higher scores indicating more 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	Participants completed 2 weeks of sleep diaries assessing use of alcohol to help with sleep. Number of days reporting use of alcohol as a sleep aid was divided by the number of diaries completed to indicate the percentage of diary days they used alcohol as a sleep aid. Higher scores indicate more frequent use of alcohol as a sleep aid.	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.
Percentage of Days Using Sleep Medication	Participants completed 2 weeks of sleep diaries assessing use of sleep medication. Number of days reporting use of sleep medication was divided by the number of diaries completed to indicate the percentage of diary days they used a sleep medication. Higher scores indicate more frequent use of sleep medication.	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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: sleep; insomnia; alcohol; drinking; veteran
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2014239; K23AA026895 (U.S. NIH Grant/Contract)

Drug and device information, study documents

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