JMIR Publications

ABSTRACT

Background:

Chronic 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.

Objective:

The 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 the 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.

Methods:

In this non-randomized 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, post-treatment, 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, post-treatment, and 3-month follow-up.

Results:

Institutional Review Board (IRB) 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 complete in April 2024. Aim 1 will be measured by tracking the response to a mail-centric recruitment approach, using electronic health 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 (PROMIS 29+2) to measure change in physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, pain, and cognitive function, and self-reported sedative-hypnotic use to measure change in dose and frequency of use.

Conclusions:

Findings 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/or increase risk for negative outcomes. Clinical Trial: clinicaltrials.gov (NCT05027438)