The iTAP Study for Veterans (iTAP-V)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    68
  • sponsor
    University of Missouri-Columbia
Updated on 7 February 2022
behavior therapy
cognitive therapy
cognitive behavioral therapy for insomnia
Accepts healthy volunteers

Summary

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

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.

Details
Condition Insomnia, Alcohol; Harmful Use
Treatment Cognitive Behavioral Therapy for Insomnia, Sleep Hygeine
Clinical Study IdentifierNCT03804788
SponsorUniversity of Missouri-Columbia
Last Modified on7 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Veteran deployed for military service after September 11, 2001
+ 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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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