An interventional study of e-CBT-I and e-HE in Insomnia, sponsored by Chinese University of Hong Kong. Completed at 2 sites in 2 countries. Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Prevention
This study aims to conduct a randomized control trial to validate the treatment effect of e-based cognitive behavioral therapy for Insomnia (e-CBT-I) on insomnia disorder, and explore whether e-CBT-I could prevent depression and suicide in youths with insomnia and subclinical depression. In addition, to further explore the mechanisms underlying the association between insomnia treatments and psychiatric disorders, this study will evaluate whether changes in candidate factors including insomnia symptoms, poor sleep hygiene, sleep-related unhelpful thoughts and maladaptive behaviors, circadian rhythm disruption and chronic sleep deprivation will mediate the effect of e-CBT-I on prevention of depression and suicide.
Previous studies have documented the associations of insomnia with depression and suicide. Currently, researchers have done considerable work to investigate whether e-CBT-I could be effective in improving psychological well-being for adults, and previous studies have confirmed that e-CBT-I is effective in reducing depressive symptoms and suicidal ideation in adult population.
However, such studies have not been established in youths yet. Additionally, it is still unclear that by which mechanisms e-CBT-I might affect mental health, and whether e-CBT-I could reduce the risk of depression and suicide.
This study will be the first specifically designed investigation of the preventive effects of e-CBT-I for depression and suicide in youths, and the first large scale causal test of the relationship between insomnia treatments and psychiatric disorders. The results can be expected to influence care provision for the youth population who are at a life stage of emerging adulthood and vulnerable to psychiatric disorders. Further, because the investigators will be using an e-CBT-I approach, a scalable solution may be demonstrated as both feasible and effective. The findings of this study will show the possibility of developing novel preventive intervention for depression and suicide by targeting insomnia.
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Exclusion Criteria:
The e-CBT-I will be delivered by a mobile application (eSleep) developed by BestCare \& SuMian BioTech Co., Ltd. which contains a digital, self-paced, and highly interactive programme. It consists of six weekly sessions with animated elements, including an overview of sleep, sleep restriction, stimulus control, cognitive therapy, structured worry time and relapse prevention. Participants will have access to the e-CBT-I treatment for 12 weeks.
Behavioral: e-CBT-I
The e-HE, a psychoeducation/information-approach, also consists of six consecutive sessions which contains information about general sleep knowledge, functions of human organs, nutrition, environmental health, brain health, identification and treatments of common diseases, but the contents are not related to any active therapeutic components of cognitive behavioral therapy for insomnia (CBT-I). Participants will have access to the intervention for 12 weeks.
Behavioral: e-HE
The e-CBT-I will be delivered through a mobile application (eSleep) with a personal password.
The e-HE will be delivered in control though a mobile application (eSleep) with a personal password.
Number of Participants With Major Depressive Disorder
Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).
Time frame: Up to 12-month follow-up
Change of Depressive Symptoms
Depressive symptoms will be measured by Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a commonly used self-administered questionnaire to assess depressive symptoms and severity, with a higher total score suggesting more severe depressive symptoms. Scores range from 0 to 27.
Time frame: Baseline, post-session 2, post-session 4, post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up
Change of Insomnia Symptoms
Insomnia symptoms will be measured by Insomnia Severity Index (ISI). ISI is a seven-item 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.
Time frame: Baseline, post-session 2 (week 3/at the conclusion of session 2), post-session 4 (week 5/at the conclusion of session 4), post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up
Percentage of Participants in Remission of Insomnia Disorder
Insomnia disorder will be confirmed by International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research.
Time frame: Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up
Change of Anxiety Symptoms
Anxiety symptoms will be measured by Generalised Anxiety Disorder 7-item (GAD-7). GAD-7 is a self-report measure of anxiety severity, with a higher total score suggesting more severe anxiety symptoms. Scores range from 0 to 21.
Time frame: Baseline, post-session 2 (week 3/at the conclusion of session 2), post-session 4 (week 5/at the conclusion of session 4), post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up
Percentage of Participants With Suicidality
Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI.
Time frame: Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up
Change of Suicidal Ideation
Suicidal ideation will be measured by Beck Scale for Suicide Ideation (BSSI). BSSI is a 19-item self-report measure designed to assess suicidality, with higher total scores representing greater. Scores range from 0 to 38.
Time frame: Baseline, post-intervention, 6- and 12-month follow-up
Change of Daytime Symptoms
Daytime symptoms will be measured by Multidimensional Fatigue Inventory (MFI). MFI is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.
Time frame: Baseline, post-intervention, 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.
Time frame: Baseline, post-intervention, 6- and 12-month follow-up
Change of Circadian Rhythms
Circadian rhythms will be measured by reduced version of Horne and Östberg Morningness-Eveningness Questionnaire (rMEQ). 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.
Time frame: Baseline, post-intervention, 6- and 12-month follow-up
Change of Subjective Sleep Measure (Time in Bed, TIB)
TIB will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Time frame: Baseline, post-intervention, 6- and 12-month follow-up
Change of Subjective Sleep Measure (Total Sleep Time, TST)
TST will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Time frame: Baseline, post-intervention, 6- and 12-month follow-up
Change of Subjective Sleep Measure (Sleep Onset Latency, SOL)
SOL will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Time frame: Baseline, post-intervention, 6- and 12-month follow-up
Change of Subjective Sleep Measure (Wake After Sleep Onset, WASO)
WASO will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Time frame: Baseline, post-intervention, 6- and 12-month follow-up
Change of Subjective Sleep Measure (Sleep Efficiency, SE)
SE will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Time frame: Baseline, post-intervention, 6- and 12-month follow-up
| Milestone | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) |
|---|---|---|
| Started | 354 | 354 |
| Completed | 315 | 319 |
| Not completed | 39 | 35 |
Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).
| Participants | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) |
|---|---|---|
| Number of Participants With Major Depressive Disorder | 37 | 62 |
Depressive symptoms will be measured by Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a commonly used self-administered questionnaire to assess depressive symptoms and severity, with a higher total score suggesting more severe depressive symptoms. Scores range from 0 to 27.
| score on a scale | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) |
|---|---|---|
| Baseline | 12.1 ± 0.2 | 12.1 ± 0.2 |
| Post-session 2 | 7.6 ± 0.2 | 7.7 ± 0.2 |
| Post-session 4 | 6.1 ± 0.2 | 7.0 ± 0.2 |
| Post-intervention | 5.1 ± 0.2 | 6.2 ± 0.2 |
| 6-month | 5.4 ± 0.2 | 6.3 ± 0.2 |
| 12-month | 5.5 ± 0.2 | 6.0 ± 0.2 |
Insomnia symptoms will be measured by Insomnia Severity Index (ISI). ISI is a seven-item 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.
| score on a scale | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) |
|---|---|---|
| Baseline | 18.3 ± 0.2 | 18.3 ± 0.2 |
| Post-session 2 | 11.5 ± 0.2 | 12.1 ± 0.2 |
| Post-session 4 | 9.0 ± 0.2 | 10.7 ± 0.2 |
| Post-intervention | 7.3 ± 0.2 | 9.3 ± 0.2 |
| 6-month | 7.2 ± 0.2 | 8.4 ± 0.2 |
| 12-month | 7.3 ± 0.2 | 8.2 ± 0.2 |
Insomnia disorder will be confirmed by International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research.
| percentage of participants | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) |
|---|---|---|
| Post-intervention | 52 | 28 |
| 6-month | 56 | 44 |
| 12-month | 57 | 48 |
Anxiety symptoms will be measured by Generalised Anxiety Disorder 7-item (GAD-7). GAD-7 is a self-report measure of anxiety severity, with a higher total score suggesting more severe anxiety symptoms. Scores range from 0 to 21.
| score on a scale | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) |
|---|---|---|
| Baseline | 7.7 ± 0.2 | 7.9 ± 0.2 |
| Post-session 2 | 5.8 ± 0.2 | 6.2 ± 0.2 |
| Post-session 4 | 4.6 ± 0.2 | 5.6 ± 0.2 |
| Post-intervention | 4.0 ± 0.2 | 4.9 ± 0.2 |
| 6-month | 4.3 ± 0.2 | 5.0 ± 0.2 |
| 12-month | 4.4 ± 0.2 | 4.8 ± 0.2 |
Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI.
| percentage of participants | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) |
|---|---|---|
| Post-intervention | 15 | 15 |
| 6-month | 19 | 13 |
| 12-month | 14 | 15 |
Suicidal ideation will be measured by Beck Scale for Suicide Ideation (BSSI). BSSI is a 19-item self-report measure designed to assess suicidality, with higher total scores representing greater. Scores range from 0 to 38.
Results for this outcome have not been posted.
Daytime symptoms will be measured by Multidimensional Fatigue Inventory (MFI). MFI is a 20-item self-rated scale on fatigue symptoms. There are three subscales, measuring the physical (possibly scored from 7 to 35), mental (possibly scored from 6 to 30), and spiritual (possibly scored from 7 to 35), dimensions of fatigue. A grand total score can be calculated by summing up the three sub scores. In all cases, a higher score represents higher fatigue symptoms.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Circadian rhythms will be measured by reduced version of Horne and Östberg Morningness-Eveningness Questionnaire (rMEQ). 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.
Results for this outcome have not been posted.
TIB will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Results for this outcome have not been posted.
TST will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Results for this outcome have not been posted.
SOL will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Results for this outcome have not been posted.
WASO will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Results for this outcome have not been posted.
SE will be estimated by 7-Day Daily Sleep Diary. 7-Day Daily Sleep Diary is a prospective measure that includes the questions to assess bedtime, time to fall asleep, total length of time awake during the night, number of awakenings during the night, final wake time and rise time, time spent in bed, total sleep time, sleep quality during the previous night (rating 0-10).
Results for this outcome have not been posted.
Collected over Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | 0/354 (0%) | 0/354 (0%) | 0/354 (0%) |
| E-based Health Education (e-HE) | 0/354 (0%) | 0/354 (0%) | 0/354 (0%) |
| Age, Continuous(years) | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) | Total |
|---|---|---|---|
| Mean | 21.9 ± 2.0 | 22.2 ± 1.9 | 22.1 ± 1.9 |
| Sex: Female, Male(Participants) | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) | Total |
|---|---|---|---|
| Female | 202 | 205 | 407 |
| Male | 152 | 149 | 301 |
| Race/Ethnicity, Customized(Participants) | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) | Total |
|---|---|---|---|
| Chinese | 354 | 354 | 708 |
| Region of Enrollment(participants) | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) | Total |
|---|---|---|---|
| Hong Kong | 18 | 23 | 41 |
| China | 336 | 331 | 667 |
| Insomnia Severity Index(units on a scale) | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) | Total |
|---|---|---|---|
| Mean | 18.3 ± 2.7 | 18.3 ± 2.6 | 18.3 ± 2.7 |
| Patient Health Questionnaire-9(units on a scale) | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | E-based Health Education (e-HE) | Total |
|---|---|---|---|
| Mean | 12.1 ± 3.2 | 12.1 ± 3.4 | 12.1 ± 3.3 |
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Sleep Initiation and Maintenance Disorders→
Chinese University of Hong Kong