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 range18 Years

SexALL

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

What they're measuring

Recruitment

Timeframe: Assessed at baseline

Retention

Timeframe: Assessed at post-treatment (week 6)

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.

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.

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.

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.

Sleep Efficiency

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.

Trial details

NCT IDNCT03804788

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-30

Results submitted2024-08-14

View on ClinicalTrials.gov More Insomnia trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Recruitment

Timeframe: Assessed at baseline

Retention

Timeframe: Assessed at post-treatment (week 6)

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.

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.

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.

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.

Sleep Efficiency

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.