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Digital Cognitive Behavioral Treatment of Insomnia in Youth: Protocol for an RCT Examining Feasibility,

Christina S McCrae1, Melanie A Stearns1, Micah O Mazurek2

  • 1Sleep and Health Innovations in Neurobehavioral (SHINE) Science Center, College of Nursing, University of South Florida, Tampa, FL, USA.

Behavioral Sleep Medicine
|May 29, 2026
PubMed

Insights

This study will be the first to test a digital Cognitive Behavioral Treatment for Insomnia (dCBTi) in children. The trial will assess if dCBTi improves sleep and daytime functioning for children and their caregivers.

Area of Science:

  • Pediatric Sleep Medicine
  • Behavioral Health
  • Digital Therapeutics

Background:

  • Chronic insomnia affects up to 20% of children, leading to impaired academic performance and behavioral issues.
  • It also impacts caregivers, causing stress and fatigue.
  • Current treatments like Cognitive Behavioral Treatment for Insomnia (CBTi) are effective but lack accessibility.

Purpose of the Study:

  • To investigate the efficacy of a moderated digital CBTi (dCBTi) for school-aged children with chronic insomnia.
  • To evaluate the impact of dCBTi on sleep quality, daytime functioning, and quality of life in children and their caregivers.
  • To address the gap in research regarding dCBTi randomized controlled trials (RCTs) in pediatric populations.

Main Methods:

  • A randomized controlled trial involving 40 child-caregiver dyads aged 6-12 with insomnia.
  • Participants will be randomized to immediate dCBTi or a waitlist control group.
  • Assessments include objective/subjective sleep measures, daytime functioning, quality of life, and physiological arousal at baseline, post-treatment, and 1- and 3-month follow-ups.

Main Results:

  • This section will report findings after data collection and analysis, comparing outcomes between the dCBTi and waitlist control groups.
  • Results will detail improvements in child and caregiver sleep, mood, executive functioning, and stress levels.
  • Physiological arousal measures, such as heart rate variability, will also be analyzed.

Conclusions:

  • Digital CBTi (dCBTi) holds promise for increasing accessibility to effective insomnia treatment for children.
  • This trial's findings will provide crucial evidence on the efficacy of dCBTi in a pediatric population.
  • Successful implementation of dCBTi could significantly improve sleep and well-being for children and their families.
Abstract

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