InsomniaNCT05451524
Prevention of Insomnia in At-risk Youth
A study testing Insomnia prevention program and General health education in people with Insomnia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Insomnia prevention program and General health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2022to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Psychiatry
Shatin, NT, 000
NGAN YIN CHAN, PhD, rachelyan123@hotmail.com
About this study
Official title: Prevention of Insomnia in At-risk Youth: A Randomized Controlled Trial Comparing Cognitive Behavioural Prevention Programme for Insomnia With Active Control Condition
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.
Read the 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
- Being tested
- Insomnia prevention program, General health education
- Keywords
- insomnia, prevention, at-risk youth, cognitive behavioral approach, active control group
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insomnia prevention programBehavioural
Youths in the intervention group will receive 4 weekly insomnia prevention program. Each session will last for about 60-90 mins.
General health educationBehavioural
Youths in the control group will be provided with group-based general health education with same dosage (4 weeks) as intervention group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: General health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Secondary outcomes (12)
Change of sleep parameters as measured by 7-day sleep diary
Seven-day sleep diary is a prospective measure that includes the questions to assess time in bed, sleep duration, wake after sleep onset, sleep latency and sleep efficiency.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Change of score in vulnerability to stress-related insomnia
Vulnerability to stress-related insomnia will be measured by Ford Insomnia Response to Stress Test (FIRST). It includes nine items, and participants were asked to rate on a 4-point Likert scale to indicate their likelihood of sleep disturbance in response to the commonly experienced stressful situations. A higher total score represents a greater vulnerability of sleep disturbance. The total score ranges from 9 to 36.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Change of sleep-related thoughts and behaviors
Sleep-related thoughts and behaviors will be measured by Brief Version of Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16). DBAS-16 is a 16-item self-report measure designed to evaluate a subset of those sleep related cognition, with a higher score indicating more dysfunctional beliefs and attitudes about sleep. The total score is calculated from the average score of all the items on the scale and could range from 0 to 10.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Change of daytime sleepiness
Daytime sleepiness will be measured by Pediatric Daytime Sleepiness Scale (PDSS). It is an 8-item inventory designed for use with school children and youths, with a higher score indicating greater sleepiness. Scores ranged from 0 to 32.
Measured: baseline, week 5 3-, 6-, and 12-month follow up
Daytime fatigue
Daytime fatigue will be assessed by Multidimensional Fatigue Inventory (MFI) that measure five dimensions of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. MFI is a self-report instrument consisting of 20 items. Each subscale contains four items. The total scores of each subscale range from 4 to 20, with a higher score indicating greater fatigue.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Change of self-reported cognitive failures
Cognitive Failures Questionnaire (CFQ) is an indicator of self-reported failures in perception, memory, and motor function, with a higher score indicating an increased vulnerability to stress. Scores range from 0 to 100.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Change of anxiety and depressive symptoms
Anxiety and depressive symptoms will be measured by Hospital Anxiety and Depression Scale (HADS). The HADS consists of two subscales for anxiety (HADS-A) and depression (HADS-D). A higher total score of each subscale represents a greater severity of depression/anxiety. The total score for each subscale ranges from 0 to 21.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Change of health related quality of life
Quality of life will be measured by kidscreen-27 Health related quality of life (HRQoL) that consists of 27 items to assess five dimensions of quality of life, including physical well-being (possibly scored from 5 to 25), psychological well-being (possibly scored 7 to 35), autonomy \& parents (possibly scored 7 to 35), peers \& social support (possibly scored 4 to 20), and school environment (possibly scored 4 to 20). A grand total score can be calculated by summing up the five sub scores. In all cases, a higher score represents higher perceived well-being.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Change of sleep hygiene
Adolescent sleep behaviors will be measured by Adolescent Sleep Hygiene Scale revised (ASHSr). ASHSr is a self-reported questionnaire with eight subscales: physiological, cognitive, emotional, sleep environment, daytime sleep, substance, sleep stability and bedtime routine. A higher score indicates a better sleep practice. The total score is calculated from the average score of all the items on the scale and could range from 1 to 6.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Change of pre-sleep arousal behaviors
Pre-Sleep Arousal Scale (PSAS) is a 16-item, self-reported questionnaire comprising both cognitive and somatic manifestations of arousal, with eight items in each subscale. Two subscale scores ranging from 8 to 40 were computed separately. A higher score suggesting higher pre-sleep arousal.
Measured: baseline, week 5, 3-, 6-, and 12-month follow up
Change of academic performance
Official record of academic performance at both baseline and end of study (at 12 months) will be collected.
Measured: baseline and 12-month follow up
Change of adolescent's perception and attitude towards sleep
Adolescent's perception and attitude towards sleep will be captured by 10-item Charlotte Attitudes Towards Sleep Scale (CATS). The CATS Scale included 2 subscales: the Benefits subscale the Time Commitment subscale. The 5 items within each subscale can be averaged, and all 10 items can be averaged to create a total score ranging from 1 to 7, with higher scores indicating more favorable attitudes towards sleep.
Measured: baseline, week 5 3-, 6-, and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jul 2022
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN NGAN YIN, Chinese University of Hong Kong
- Investigators
- NGAN YIN CHAN, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451524
- Sponsor's protocol ID
- 2021.005
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2022
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Insomnia in At-risk Youth: A Randomized Controlled Trial Comparing Cognitive Behavioural Prevention Programme for Insomnia With Active Control Condition
- ClinicalTrials.gov ID
- NCT05451524
- Acronym / sponsor ID
- 2021.005
- Conditions
- Insomnia
- Keywords
- insomnia, prevention, at-risk youth, cognitive behavioral approach, active control group
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia prevention program | Experimental | Behavioral: Insomnia prevention programThe 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. |
| General health education | Active comparator | Behavioral: General health educationIn 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. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insomnia prevention programYouths in the intervention group will receive 4 weekly insomnia prevention program. Each session will last for about 60-90 mins. | Behavioural | Insomnia prevention program |
| General health educationYouths in the control group will be provided with group-based general health education with same dosage (4 weeks) as intervention group. | Behavioural | General health education |
Primary outcome
Insomnia disorder incidence
Time frame: week 5
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.
Insomnia disorder incidence
Time frame: 3-month follow up
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.
Insomnia disorder incidence
Time frame: 6-month follow up
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.
Insomnia disorder incidence
Time frame: 12-month follow up
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.
Change of insomnia symptoms
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
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.
12 secondary outcomes
Change of sleep parameters as measured by 7-day sleep diary
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
Change of score in vulnerability to stress-related insomnia
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
Change of sleep-related thoughts and behaviors
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
Change of daytime sleepiness
Time frame: baseline, week 5 3-, 6-, and 12-month follow up
Daytime fatigue
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
Change of self-reported cognitive failures
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
Change of anxiety and depressive symptoms
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
Change of health related quality of life
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
Change of sleep hygiene
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
Change of pre-sleep arousal behaviors
Time frame: baseline, week 5, 3-, 6-, and 12-month follow up
Change of academic performance
Time frame: baseline and 12-month follow up
Change of adolescent's perception and attitude towards sleep
Time frame: baseline, week 5 3-, 6-, and 12-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
NGAN YIN CHAN, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insomnia prevention program and General health education in people with Insomnia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NGAN YIN CHAN, PhD (+852 39197792, rachel.chan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia disorder incidence (time frame: week 5). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.