Digital Insomnia Intervention for Chronic Insomnia
(SEDATIVE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAdam D. Bramoweth, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

Chronic insomnia is one of the most common health problems among Veterans and significantly impacts their health, function, and quality of life. Sedative-hypnotic medications are the most common treatment despite mixed effectiveness and are associated with numerous risks that can further impact Veteran function. An intervention combining evidence-based interventions for deprescribing sedative-hypnotics and behavioral interventions for insomnia can help to optimize sleep and functional outcomes for Veterans with a desire to reduce or stop using these medications. Furthermore, by delivering these interventions through an easy to use and highly accessible digital platform can provide additional benefits to Veterans, especially those with limited time and access to engage in traditional in-person interventions. The Clinician Operated Assistive Sleep Technology (COAST) is an efficient, scalable, and adaptable platform that can help providers to reach more Veterans and provide evidence-based care that translates to improved health and function. Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to participate in a 12-week combined deprescribing and CBT-I intervention, delivered through the COAST digital platform. Aim 2: To assess Veteran acceptability and usability of the COAST platform. Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-intervention.

Research Team

Adam D. Bramoweth, PhD

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility Criteria

This trial is for Veterans at VA Pittsburgh Healthcare System who use sleep meds more than half the month for over 3 months and want to cut down or stop. They must have internet access on a mobile device. It's not for those with severe health issues, conditions worsened by sleep changes, high suicide risk, or recent substance abuse.

Inclusion Criteria

Access to a mobile device with internet

I want to cut down or stop taking sleep or anxiety medication.

A Veteran receiving care at VA Pittsburgh Healthcare System

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Exclusion Criteria

I do not have any health issues that would stop me from joining the study.

High risk of suicide

A disorder that can be exacerbated by changes in sleep (e.g., seizure disorder, bipolar I disorder)

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Treatment Details

Interventions

Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention)
Deprescribing (Behavioral Intervention)

Trial OverviewThe study tests a digital program called COAST that combines cutting back on sleep meds with Cognitive Behavioral Therapy for Insomnia (CBT-I). Over 12 weeks, it aims to see if this approach is workable and helpful in improving Veterans' sleep and reducing their reliance on medications.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: COAST + DeprescribingExperimental Treatment2 Interventions

CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform