Prevention of Insomnia in At-risk Youth

  • End date
    Jul 15, 2024
  • participants needed
  • sponsor
    Chinese University of Hong Kong
Updated on 4 September 2023
Accepts healthy volunteers


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.


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.

Condition Insomnia
Treatment General Health Education, Insomnia prevention program
Clinical Study IdentifierNCT05451524
SponsorChinese University of Hong Kong
Last Modified on4 September 2023


Yes No Not Sure

Inclusion Criteria

Youth aged between 15-24 years (as defined by WHO)
Written informed consent of participation into the study is given by youth and his/her parents if under 18 years old; In addition, individual assent will also be obtained for subjects under age 18 years old
Have subclinical insomnia symptoms (at least once a month but less than 3 times/week in the past one month)
At least one of the biological parents with current or lifetime history of insomnia disorder as defined by DSM-V diagnostic criteria

Exclusion Criteria

A current or past history of neuropsychiatric disorder(s)
A prominent medical condition or taking medication with potential side effects that may influence sleep quantity and quality
Having a diagnosed sleep disorder that may potentially contribute to the disruption of sleep quantity and quality as ascertained by both Structured Diagnostic Interview for Sleep patterns and Disorders (DISP) such as insomnia, delayed sleep phase and narcolepsy, restless leg syndrome
Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt)
Currently receiving any structured psychotherapy
With hearing or speech deficit
Trans-meridian flight in the past 3 months and during the study
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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