The iTAP Study for Veterans (iTAP-V)

• ClinicalTrials.gov Identifier: NCT03804788
• Recruitment Status: Recruiting
• First Posted: January 15, 2019
• Last Update Posted: April 9, 2021
• Sponsor: University of Missouri-Columbia
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Mary E Miller, University of Missouri-Columbia

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Insomnia; Alcohol; Harmful Use	Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Hygeine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant, Outcomes Assessor)
• Masking Description: 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).
• Primary Purpose: Treatment
• Official Title: The Impact of Insomnia Treatment on Heavy Alcohol Use Among Returning Veterans
• Actual Study Start Date: April 4, 2019
• Estimated Primary Completion Date: June 30, 2023
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

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 Name: (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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Working memory updating [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
   Assessed using the Keep Track task as described by Friedman et al (2008).
2. Working memory updating [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
   Assessed using the N-Back Task as described in Jaeggi et al (2010).
3. Working memory updating [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
   Assessed using the Letter Memory task as described in Miyake & Friedman (2012)
4. Response inhibition [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
   Assessed using the Stop Signal task
5. Self-reported executive function [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
   Assessed using the Behavior Rating Inventory of Executive Function of Adults
6. Delay discounting [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
   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.
7. Delay discounting [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
   Assessed using the 5-trial delay discounting task
8. Negative affect [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
   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.
9. Emotion regulation [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
   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.
10. Alcohol craving [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
    Assessed using the Penn Alcohol Craving Scale (PACS); PACS evaluates thoughts about drinking by assessing the duration, frequency, and intensity of such thoughts.
11. Use of alcohol to help with sleep [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
    Assessed using daily sleep diaries
12. Use of sleep medication [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
    Assessed using daily sleep diaries
13. Autonomic arousal [ Time Frame: Change from baseline to post-treatment (weeks 7-8) and 3 month follow-up (weeks 21-22) ]
    Assessed using holter monitoring devices that provide a physiological index of arousal in the autonomic nervous system.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Missouri

University of Missouri-Columbia; Recruiting

Columbia, Missouri, United States, 65212

Contact: Mary Beth Miller, PhD 573-882-1813 millmary@health.missouri.edu

Contact: Nicole Hall, BA 573-882-8598 nahcdv@health.missouri.edu

Sponsors and Collaborators

University of Missouri-Columbia

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

• Responsible Party: Mary E Miller, Professor, Psychiatry, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT03804788
• Other Study ID Numbers: 2014239; K23AA026895 ( U.S. NIH Grant/Contract )
• First Posted: January 15, 2019
• Last Update Posted: April 9, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mary E Miller, University of Missouri-Columbia:

alcohol; drinking; sleep; insomnia; veteran

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders