The iTAP Study for Veterans (iTAP-V)

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.

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

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).

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

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.

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; see Kirby, Petry, & Bickel, 1999). Higher k values indicate a greater preference for smaller, immediate rewards over larger, delayed reward.

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.

Assessed using the Difficulties in Emotion Regulation Scale (DERS-16). The DERS-16 is a shortened version of the DERS scale. It measures emotion dysregulation based on subscales of clarity, goals, strategies, impulses, and non-acceptance.

Assessed using the Penn Alcohol Craving Scale (PACS); PACS evaluates thoughts about drinking by assessing the duration, frequency, and intensity of such thoughts.

Assessed using holter monitoring devices that provide a physiological index of arousal in the autonomic nervous system.

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