CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Cognitive Behavioral Therapy for Insomnia +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05027438
NCT05027438N/ACompleted

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

VA Office of Research and Development·interventional·Posted Aug 30, 2021·Updated Apr 11, 2025

In Brief

A clinical study evaluating Cognitive Behavioral Therapy for Insomnia and Deprescribing for Insomnia. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 30, 2021
Enrollment StartSep 22, 2022
Primary CompletionMar 31, 2024
Study CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.8 years ago

Interventions

Cognitive Behavioral Therapy for Insomniabehavioral

A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies

Deprescribingbehavioral

The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes