ArticleJMIR research protocols2023
Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial.
Article in JMIR research protocols, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05027438 (SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)
Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Stepped-Care Management of Insomnia: Treatment Choices Guided by a Patient Decision Aid in a Pragmatic Nonrandomized Clinical Trial Setting.Journal of sleep research · 2026Trial
- Reducing sleep medication via parallel delivery of clinical pharmacist-led deprescribing and clinician-supervised asynchronous CBT for insomnia: the SEDATIVE trial.Journal of behavioral medicine · 2026Article
- The Sleep Course: An inclusive trial examining the feasibility, acceptability, and preliminary efficacy of a digital sleep intervention for adults with self-reported sleep difficulties.Internet interventions · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 1 country.
Funding
Abstract
backgroundChronic insomnia is one of the most common health problems among veterans and negatively impacts their health, function, and quality of life. Although cognitive behavioral therapy for insomnia (CBT-I) is the first-line recommended treatment, sedative-hypnotic medications remain the most common. Sedative-hypnotics, however, have mixed effectiveness, are frequently prescribed longer than recommended, and are associated with numerous risks and adverse effects that negatively impact veteran function. Meeting the treatment needs of veterans impacted by insomnia requires delivering gold standard behavioral care, like CBT-I, and the reduction of sedative-hypnotics through innovative methods.
objectiveThe objective of this feasibility clinical trial is to test a digital CBT-I approach combined with deprescribing to improve the success of sedative-hypnotic reduction among veterans. The intervention combines Noctem Health Clinician Operated Assistive Sleep Technology (COAST), an effective and efficient, scalable, and adaptable digital platform to deliver CBT-I, with clinical pharmacy practitioner (CPP)-led deprescribing of sedative-hypnotic medications.
methodsIn this nonrandomized single-group clinical trial, 50 veterans will be recruited and enrolled to receive CBT-I delivered via Noctem COAST and CPP-led deprescribing for up to 12 weeks. Assessments will occur at baseline, posttreatment, and 3-month follow-up. The aims are to (1) assess the feasibility of recruiting veterans with chronic sedative-hypnotic use to participate in the combined intervention, (2) evaluate veterans' acceptability and usability of the COAST platform, and (3) measure changes in veterans' sleep, sedative-hypnotic use, and function at baseline, posttreatment, and 3-month follow-up.
resultsThe institutional review board approved the study in October 2021 and the trial was initiated in May 2022. Recruitment and data collection began in September 2022 and is anticipated to be completed in April 2024. Aim 1 will be measured by tracking the response to a mail-centric recruitment approach using electronic medical records to identify potentially eligible veterans based on sedative-hypnotic use. Aim 2 will be measured using the Post-Study System Usability Questionnaire, assessing overall usability as well as system usefulness, information quality, and interface quality. Aim 3 will use the Insomnia Severity Index and sleep diaries to measure change in insomnia outcomes, the Patient-Reported Outcome Measurement Information System Profile to measure change in physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, pain, cognitive function, and self-reported sedative-hypnotic use to measure change in dose and frequency of use.
conclusionsFindings will inform the utility of a combined digital CBT-I and CPP-led deprescribing intervention and the development of an adequately powered clinical trial to test the effectiveness in a diverse sample of veterans. Further, findings will help inform potential new approaches to deliver care and improve access to care for veterans with insomnia, many of whom use sedative-hypnotics that may be ineffective and increase the risk for negative outcomes.
trial registrationClinicalTrials.gov NCT05027438; https://classic.clinicaltrials.gov/ct2/show/NCT05027438. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47636.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.