The iTAP Study for Veterans (NCT03804788) | Clinical Trial Compass
CompletedNot Applicable
The iTAP Study for Veterans
United States71 participantsStarted 2019-04-04
Plain-language summary
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment
Timeframe: Assessed at baseline
2
Retention
Timeframe: Assessed at post-treatment (week 6)
3
Drinking Quantity
Timeframe: 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.
4
Alcohol-related Consequences
Timeframe: 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.
5
Insomnia Symptoms
Timeframe: 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.
6
Sleep Quality
Timeframe: 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.
Timeframe: 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.