NCT05451524

Prevention of Insomnia in At-risk Youth

Prevention of Insomnia in At-risk Youth: A Randomized Controlled Trial Comparing Cognitive Behavioural Prevention Programme for Insomnia With Active Control Condition

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 15 Years – 24 Years
• Healthy volunteers: Accepted

Summary

This study aims to conduct a randomized controlled trial in comparing cognitive behavioral insomnia prevention program with the active control group in youths who are at risk of insomnia. The results of this study will allow us to take this potential efficacious prevention program to scale and reduce the associated burden of insomnia in the future.

Detailed description

Adolescence is a vulnerable period for the emergence of insomnia, which affects more than 10% of the youths (approximately 40% if based on symptoms). Insomnia in youths tends to run a protracted course and is associated with numerous negative outcomes including poor quality of life, cognitive and academic impairment, and predisposing to development of depression and anxiety. The burden arises from insomnia has been increasingly recognized worldwide as a debilitating and costly public health concern. However, insomnia in youths is often ignored and under-treated, with only 10% of the local youths recognized their insomnia problem and none of them has received the recommended first-line treatment - cognitive behavioral therapy for insomnia (CBT-I). Given the high prevalence, chronicity and long-lasting health-related consequences of insomnia, together with the delay and limited help-seeking behavior, it calls the urgent need for early insomnia prevention and intervention in this vulnerable population. Thus, this study aims to conduct a randomized controlled trial in comparing cognitive behavioral insomnia prevention program with the active control group in youths who are at risk of insomnia and to explore the effect of prevention program in preventing the incidence of insomnia problems.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Insomnia prevention program	Youths in the intervention group will receive 4 weekly insomnia prevention program. Each session will last for about 60-90 mins.
BEHAVIORAL	General health education	Youths in the control group will be provided with group-based general health education with same dosage (4 weeks) as intervention group.

Timeline

• Start date: 2022-07-01
• Primary completion: 2026-04-15
• Completion: 2026-07-15
• First posted: 2022-07-11
• Last updated: 2025-07-10

Locations

1 site across 1 country: Hong Kong