Prevention of Insomnia in At-risk Youth

NCT ID: NCT05451524

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2026-07-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Insomnia prevention program

The preventive program has been developed and modified as based on the evidence-based CBT-I insomnia treatment.

Active intervention group will be conducted in group size with 6-8 subjects who are from the same education level (i.e. secondary vs university). Youths in the intervention group will receive 4 weekly insomnia prevention program conducted by the sleep therapists who has received training in conducting CBT-I under close supervision of sleep experts. Each session will last for about 60-90 mins.

Group Type: EXPERIMENTAL

Insomnia prevention program

Intervention Type: BEHAVIORAL

Youths in the intervention group will receive 4 weekly insomnia prevention program. Each session will last for about 60-90 mins.

General health education

In order to control for placebo effect and other non-specific factors such as contact time, youths in the control group will be provided with group-based general health education with same dosage (4 weeks) as intervention group. Modules will contain information about general well-being, diet, nutrition, and activity. It is expected that this health education will be an active control group to account for most of the non-specific effects including time, attention, therapist, and peer support.

Group Type: ACTIVE_COMPARATOR

General health education

Intervention Type: BEHAVIORAL

Youths in the control group will be provided with group-based general health education with same dosage (4 weeks) as intervention group.

Interventions

Insomnia prevention program

Youths in the intervention group will receive 4 weekly insomnia prevention program. Each session will last for about 60-90 mins.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CHAN NGAN YIN

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NGAN YIN CHAN, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Department of Psychiatry

Shatin, NT, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

NGAN YIN CHAN, PhD

Role: CONTACT

rachel.chan@cuhk.edu.hk

+852 39197792

Sijing Chen, PhD

Role: CONTACT

sijingchen@cuhk.edu.hk

+85239197792

Facility Contacts

NGAN YIN CHAN, PhD

Role: primary

rachelyan123@hotmail.com

Other Identifiers

2021.005

Identifier Type: -

Identifier Source: org_study_id