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NCT Number: NCT05451524

Prevention of Insomnia in At-risk Youth

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.

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Key information

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry

Shatin, NT, 000, Hong Kong

Location status: Recruiting

Location contact

NGAN YIN CHAN, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Change of sleep parameters as measured by 7-day sleep diary

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

    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.

  2. Change of score in vulnerability to stress-related insomnia

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

    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.

  3. Change of sleep-related thoughts and behaviors

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

    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.

  4. Change of daytime sleepiness

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

    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.

  5. Daytime fatigue

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

    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.

  6. Change of self-reported cognitive failures

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

    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.

  7. Change of anxiety and depressive symptoms

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

    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.

  8. Change of health related quality of life

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

    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.

  9. Change of sleep hygiene

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

    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.

  10. Change of pre-sleep arousal behaviors

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

    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.

  11. Change of academic performance

    Time frame: baseline and 12-month follow up

    Official record of academic performance at both baseline and end of study (at 12 months) will be collected.

  12. Change of adolescent's perception and attitude towards sleep

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

    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.

Other outcomes

  1. Major life events and self-perceived stress

    Time frame: baseline and 12-month follow up

    Major life events and self-perceived stress associated with these events that an individual experienced over the year will be measured by 57-item Life Experience Survey (LES). Ratings are on a 7-point scale ranging from extremely negative (-3) to extremely positive (+3). Summing the impact ratings of those events designated as positive by the subject provides a positive change score. A negative change score is derived by summing the impact ratings of those events experienced as negative by the subject. By adding these two values, a total change score can be obtained, representing the total amount of rated change, and can range from 0 to 171.

  2. Change of chronotype

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

    The chronotype of the study participants will be measured by Morningness-Eveningness Questionnaire (MEQ). The rMEQ is a 5-item self reported measure used to evaluate circadian rhythm and sleep rhythm patterns in individuals. Individuals scored higher than 17 and lower than 12 were classified as morning-type and evening-type, respectively. Individuals scored between 12 and 17 were classified as intermediate-type. Scores range from 4 to 25.

  3. Self-reported pubertal status

    Time frame: baseline and 12-month follow up

    Tanner staging of breasts for females or genitals for males and pubic hair presented in pictures with text descriptions will be used to determine the pubertal status. A rating falls between tanner stages of one to three is classified as the pre-pubertal stage, while tanner stages four and five is classified as the post-pubertal stage.

  4. Treatment satisfaction, adherence and integrity

    Time frame: week 5

    The TSS consists of 7 items with higher scores indicating greater symptom improvement. Overall treatment satisfaction was computed as the average score which ranges from 1 to 5 on all 7 items of the TSS.

  5. Treatment adherence

    Time frame: week 5

    Treatment Component Adherence Scale (TCAS) will be used to assess treatment adherence at post intervention. The TCAS consists of 6 items with higher scores indicating better adherence. Scores range from 0 to 18

  6. Treatment expectancy and credibility

    Time frame: week 5

    Credibility-Expectancy Questionnaire (CEQ) for assessment of treatment expectancy and credibility of the intervention. The CEQ consists of 6 items with higher scores indicating greater perceptions of treatment credibility and expectations of improvement. Scores range from 5 to 30.

Study contacts

Contact information is provided by the study sponsor or research team.

NGAN YIN CHAN, PhD

CONTACT

[email protected]

+852 39197792

Sijing Chen, PhD

CONTACT

[email protected]

+85239197792

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2022
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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