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

Area of Science:

• Sleep Medicine
• Digital Health
• Behavioral Science

Background:

• Chronic insomnia affects many, yet few receive recommended Cognitive Behavioural Therapy for Insomnia (CBT-I).
• Digital therapies offer scalable solutions, but comparative efficacy data is lacking.
• Identifying optimal technology-enabled treatments is crucial for improving patient care.

Purpose of the Study:

• To compare the efficacy and cost-benefits of Intensive Sleep Retraining (THIM), Sleep Healthy Using the Internet (SHUTi), and a combination (THIM then SHUTi) against a waitlist control.
• To evaluate these digital interventions for chronic insomnia disorder.

Main Methods:

• A 4x3 randomized controlled trial comparing four treatment arms (+/- THIM, +/- SHUTi) across three time points (pre-treatment, post-treatment, 2-month follow-up).
• Participants with Chronic Insomnia Disorder were randomized.
• Outcomes assessed via daily/weekly self-reports and objective sleep trackers; primary outcome: total wake time.

Main Results:

• The study is designed to analyze the interaction between treatment group and time on total wake time using repeated measures ANOVA.
• A reduction of ≥30 minutes in total wake time is considered clinically meaningful.
• Results will provide comparative data on the effectiveness of different digital insomnia treatments.

Conclusions:

• This research will be the first to directly compare the efficacy of two distinct technology-enabled insomnia treatments.
• Findings will inform clinical practice and public health policy on digital health interventions for insomnia.
• The study will guide the use of publicly and privately funded technology-enabled insomnia solutions.