Clinical trial NCT03804788: The iTAP Study for Veterans
Official title: The Impact of Insomnia Treatment on Heavy Alcohol Use Among Returning Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Alcohol; Harmful Use
Keywords: alcohol
drinking
sleep
insomnia
veteran
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-01-15
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Recruitment
timeFrame: Assessed at baseline
measure: Retention
timeFrame: Assessed at post-treatment (week 6)
measure: 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.
measure: 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.
measure: 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.
measure: 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.
measure: 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.
measure: Client Satisfaction
timeFrame: Mean score at post-treatment (week 6).
Secondary outcomes:
measure: Delay Discounting
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.
measure: Negative Affect
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.
measure: Emotion Regulation
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.
measure: Alcohol Craving
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.
measure: Percentage of Days Using Alcohol to Help With Sleep
timeFrame: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
measure: Percentage of Days Using Sleep Medication
timeFrame: Primary analyses will measure between-group change at post (week 6) and follow-up (week 20). Mean values at each time point are presented below.
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
References: