This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
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.
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.
University of Missouri-Columbia
Columbia, Missouri, United States
Recruitment
Number of eligible participants who enrolled in the study
Time frame: Assessed at baseline
Retention
Number of participants who complete all treatment sessions
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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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%.
Time frame: 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.
Time frame: Mean score at post-treatment (week 6).
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").
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.