The iTAP Study for Veterans (iTAP-V)

University of Missouri (MU)

Status

Completed

Conditions

Alcohol; Harmful Use

Insomnia

Treatments

Behavioral: Cognitive Behavioral Therapy for Insomnia

Behavioral: Sleep Hygeine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03804788

K23AA026895 (U.S. NIH Grant/Contract)

2014239

Details and patient eligibility

About

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

Full 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.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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