Prevention of Insomnia in At-risk Youth

NCT05451524 | Recruiting

• 1 other identifier: 2021.005
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

insomnia; prevention; at-risk youth; cognitive behavioral approach; active control group

Outcome Measures

Primary Outcomes (5)

• Insomnia disorder incidence

  Clinician-rated insomnia incidence is defined as having insomnia symptoms for ≥ 3 times per week for at least one month (will be able to cover both acute and chronic insomnia disorder), accompanied with clinically significant distress or impairment. The assessment will be conducted based on the DSM-V insomnia diagnostic criteria checklist with the detail record of the symptom duration.

  week 5

• Insomnia disorder incidence

  Clinician-rated insomnia incidence is defined as having insomnia symptoms for ≥ 3 times per week for at least one month (will be able to cover both acute and chronic insomnia disorder), accompanied with clinically significant distress or impairment. The assessment will be conducted based on the DSM-V insomnia diagnostic criteria checklist with the detail record of the symptom duration.

  3-month follow up

• Insomnia disorder incidence

  Clinician-rated insomnia incidence is defined as having insomnia symptoms for ≥ 3 times per week for at least one month (will be able to cover both acute and chronic insomnia disorder), accompanied with clinically significant distress or impairment. The assessment will be conducted based on the DSM-V insomnia diagnostic criteria checklist with the detail record of the symptom duration.

  6-month follow up

• Insomnia disorder incidence

  Clinician-rated insomnia incidence is defined as having insomnia symptoms for ≥ 3 times per week for at least one month (will be able to cover both acute and chronic insomnia disorder), accompanied with clinically significant distress or impairment. The assessment will be conducted based on the DSM-V insomnia diagnostic criteria checklist with the detail record of the symptom duration.

  12-month follow up

• Change of insomnia symptoms

  The severity of insomnia symptoms as measured by 7-item Insomnia Severity Index (ISI). ISI is a self-report measure designed to assess the nature, severity and impact of insomnia, with a higher total score suggesting more severe insomnia symptoms. Scores range from 0 to 28.

  baseline, week 5, 3-, 6-, and 12-month follow up

Secondary Outcomes (12)

• Change of sleep parameters as measured by 7-day sleep diary

  baseline, week 5, 3-, 6-, and 12-month follow up

• Change of score in vulnerability to stress-related insomnia

  baseline, week 5, 3-, 6-, and 12-month follow up

• Change of sleep-related thoughts and behaviors

  baseline, week 5, 3-, 6-, and 12-month follow up

• Change of daytime sleepiness

  baseline, week 5 3-, 6-, and 12-month follow up

• Daytime fatigue

  baseline, week 5, 3-, 6-, and 12-month follow up

Other Outcomes (6)

• Major life events and self-perceived stress

  baseline and 12-month follow up

• Change of chronotype

  baseline, week 5, 3-, 6-, and 12-month follow up

• Self-reported pubertal status

  baseline and 12-month follow up

Study Arms (2)

Insomnia prevention program

EXPERIMENTAL

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.

Behavioral: Insomnia prevention program

General health education

ACTIVE COMPARATOR

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.

Behavioral: General health education

Interventions

Insomnia prevention program BEHAVIORAL

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

Insomnia prevention program

General health education BEHAVIORAL

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

General health education

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry

Shatin, NT, 000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• NGAN YIN CHAN, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NGAN YIN CHAN, PhD

CONTACT

+852 39197792; rachel.chan@cuhk.edu.hk

Sijing Chen, PhD

CONTACT

+85239197792; sijingchen@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessors and statisticians, participants will be masked to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: July 11, 2022
• Study Start: July 1, 2022
• Primary Completion: April 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)