Comparing the efficacy of technology-enabled treatments for insomnia: study protocol for a randomized controlled trial.

Abstract

Chronic insomnia is a prevalent sleep disorder where <1% of patients receive the recommended first-line treatment; Cognitive Behavioural Therapy for Insomnia. Digital technologies and self-managed therapies are scalable solutions to address this critical gap in patient care, but it is presently difficult to know which therapies are best. This study will test the comparative efficacy and cost-benefits of Intensive Sleep Retraining administered by the THIM sleep tracker, Sleep Healthy Using the Internet (SHUTi) treatment program, and their combination (THIM then SHUTi) versus a waitlist control group. This study is a 4 (treatment: +/- THIM and +/- SHUTi) × 3 (time: pretreatment, posttreatment, and 2-month follow-up) randomized controlled trial. Participants who meet the diagnostic criteria for Chronic Insomnia Disorder will be randomized to one of four groups. Sleep and daytime functioning symptoms will be assessed via self-report daily and weekly questionnaires, and objective sleep trackers during treatment and for 2 weeks at pre-treatment, post-treatment, and 2-month follow-up. The primary outcome is total wake time, with a reduction of ≥30 minutes considered a clinically meaningful difference. For the primary analysis, the interaction between the treatment group and time on total wake time will be analyzed using repeated measures analyses of variance (ANOVA). This project was approved by the Southern Adelaide Clinical Human Research Ethics Committee (2021/HRE00414) and registered in the Australian and New Zealand Clinical Trials Registry (ACTRN12622000778785). As the first study to investigate the comparative efficacy of two different technology-enabled treatments for insomnia, this study will help inform clinicians and public health policy regarding the use cases for public and private health-funded technology-enabled options for insomnia.