The iTAP Study for Veterans

Not Applicable

Completed

Conditions: Alcohol; Harmful Use
Insomnia

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

Registration Number: NCT03804788

Lead Sponsor: University of Missouri-Columbia

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 71

Inclusion Criteria

Not provided

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-I	Sleep Hygeine	Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks.
CBT-I	Cognitive Behavioral Therapy for Insomnia	Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks.
Sleep Hygiene	Sleep Hygeine	Sleep hygiene handout delivered once to all participants.

Primary Outcome Measures

Name	Time	Method
Recruitment	Assessed at baseline	Number of eligible participants who enrolled in the study
Retention	Assessed at post-treatment (week 6)	Number of participants who complete all treatment sessions
Drinking Quantity	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.	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.
Alcohol-related 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.	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.
Insomnia Symptoms	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.	Assessed using Insomnia Severity Index (ISI). ISI scores from 0 to 28, with higher scores indicating more severe insomnia.
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.	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.
Sleep Efficiency	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.	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%.
Client Satisfaction	Mean score at post-treatment (week 6).	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.

Secondary Outcome Measures

Name	Time	Method
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.	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").
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.	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.
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.	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.
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.	Assessed using the Penn Alcohol Craving Scale (PACS). Scores range from 0 to 30, with higher scores indicating more craving.
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.	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.
Percentage of Days Using 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.	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.