The iTAP Study for Veterans

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

Detailed Description
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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.

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

Conditions
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Insomnia, Alcohol; Harmful Use

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia
* Behavioral: Sleep Hygeine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to receive sleep hygiene or to participate in sessions of individual Cognitive Behavioral Therapy for Insomnia (CBT-I).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-I<br>Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for six (6) weeks. | Behavioral: Cognitive Behavioral Therapy for Insomnia<br>* 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.<br>* Other names: (CBT-I);Behavioral: Sleep Hygeine<br>* 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.<br>|
| Active Comparator: Sleep Hygiene<br>Sleep hygiene handout delivered once to all participants. | Behavioral: Sleep Hygeine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Number of participants who complete baseline assessment | Assessed at post-treatment (weeks 7-8) | 
| Retention | Number of participants who complete all treatment sessions | Assessed at post-treatment (weeks 7-8) | 
| Drinking quantity | Assessed using Timeline Followback and Daily Drinking Questionnaire | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Alcohol-related consequences | Assessed using the Brief Young Adult Alcohol Consequences Questionnaire | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Insomnia symptoms | Assessed using Insomnia Severity Index (ISI); ISI evaluates self-reports of insomnia experiences | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Sleep quality | Assessed using daily sleep diaries | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Sleep efficiency | Assessed using daily sleep diaries and actigraphy | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Client satisfaction | Assessed using the Client Satisfaction Questionnaire | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Working memory updating | Assessed using the Keep Track task as described by Friedman et al (2008). | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Working memory updating | Assessed using the N-Back Task as described in Jaeggi et al (2010). | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Working memory updating | Assessed using the Letter Memory task as described in Miyake & Friedman (2012) | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Response inhibition | Assessed using the Stop Signal task | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Self-reported executive function | Assessed using the Behavior Rating Inventory of Executive Function of Adults | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| 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; see Kirby, Petry, & Bickel, 1999). Higher k values indicate a greater preference for smaller, immediate rewards over larger, delayed reward. | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Delay discounting | Assessed using the 5-trial delay discounting task | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| 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. | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Emotion regulation | 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. | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Alcohol craving | Assessed using the Penn Alcohol Craving Scale (PACS); PACS evaluates thoughts about drinking by assessing the duration, frequency, and intensity of such thoughts. | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Use of alcohol to help with sleep | Assessed using daily sleep diaries | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Use of sleep medication | Assessed using daily sleep diaries | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 
| Autonomic arousal | Assessed using holter monitoring devices that provide a physiological index of arousal in the autonomic nervous system. | Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, drinking, sleep, insomnia, veteran