NCT05027438

Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 (e.g., Cognitive Behavioral Therapy for Insomnia \[CBT-I\]) 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.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia	A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies
BEHAVIORAL	Deprescribing	The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes

Timeline

• Start date: 2022-09-22
• Primary completion: 2024-03-31
• Completion: 2024-06-30
• First posted: 2021-08-30
• Last updated: 2025-04-11
• Results posted: 2025-04-11

Locations

1 site across 1 country: United States