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| Name | Class |
|---|---|
| Peking University Sixth Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-based cognitive behavioral therapy for insomnia (e-CBT-I) | Experimental | 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. |
|
| E-based health education (e-HE) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-CBT-I | Behavioral | The e-CBT-I will be delivered through a mobile application (eSleep) with a personal password. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Depressive Disorder | Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI). | Up to 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-session 2, post-session 4, post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Kwok Wing, MBChB | Chinese University of Hong Kong | Principal Investigator |
| Lin Lu, PhD | Peking University Sixth Hospital | Principal Investigator |
| Shirley Xin Li, PhD | Hong Kong University | Study Director |
| Jihui Zhang, PhD | Chinese University of Hong Kong | Study Director |
| Le Shi, PhD | Peking University Sixth Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Sixth Hospital | Beijing | China | ||||
| Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39836656 | Derived | Chen SJ, Que JY, Chan NY, Shi L, Li SX, Chan JWY, Huang W, Chen CX, Tsang CC, Ho YL, Morin CM, Zhang JH, Lu L, Wing YK. Effectiveness of app-based cognitive behavioral therapy for insomnia on preventing major depressive disorder in youth with insomnia and subclinical depression: A randomized clinical trial. PLoS Med. 2025 Jan 21;22(1):e1004510. doi: 10.1371/journal.pmed.1004510. eCollection 2025 Jan. |
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| ID | Title | Description |
|---|---|---|
| FG000 | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | The e-CBT-I intervention is a digital, self-paced, and interactive insomnia intervention program delivered through smartphone application (esleep: Android: https://sd-oss-cdn.sumian.com/apk/eSleep\_1.0.3-release.apk; iOS: Apple App store) that was developed by our research team (Li Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR), and was modified and issued by BestCare & SuMian BioTech Co, Ltd. The Chinese version (simplified Chinese/Mandarin) of the application was designed to adapt for the language background of the participants in China. The program is developed as based on well-established CBT-I treatment protocol and consists of six 20-30 minutes sequential modules unlocked weekly with animated elements, including (1) overview of sleep, (2) sleep restriction, (3) stimulus control, (4) cognitive restructuring (targeting sleep-related dysfunctional cognitions), (5) structured worry time, and (6) relapse prevention (appendix pp 2). Participants had access to the e-CBT-I intervention for 12 weeks, allowing them additional time to complete the intervention in case they were unable to completed it within the initial 6-week period. |
| FG001 | E-based Health Education (e-HE) | The control (e-HE) condition was developed by our research team (Li Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR) and issued by BestCare & SuMian BioTech Co, Ltd. according to a psychoeducation/information approach, in order to provide the credibility of the intervention to the participants, and to control for the potential dosing effect of attention and nonspecific components (e.g., expectation and contact hours). The e-HE is a health promotion program with the same contact hours as e-CBT-I which contains information about general sleep knowledge, functions of human organs, nutrition, environmental health, brain health, identification, and treatments of common diseases, while it did not include any active insomnia and depression therapeutic components (appendix pp 2). Each module was unlocked weekly, and participants had access to the program for 12 weeks. The general sleep knowledge session was purposively added in this sleep related RCT to meet the expectation of the participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | The e-CBT-I intervention is a digital, self-paced, and interactive insomnia intervention program delivered through smartphone application (esleep: Android: https://sd-oss-cdn.sumian.com/apk/eSleep\_1.0.3-release.apk; iOS: Apple App store) that was developed by our research team (Li Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR), and was modified and issued by BestCare & SuMian BioTech Co, Ltd. The Chinese version (simplified Chinese/Mandarin) of the application was designed to adapt for the language background of the participants in China. The program is developed as based on well-established CBT-I treatment protocol and consists of six 20-30 minutes sequential modules unlocked weekly with animated elements, including (1) overview of sleep, (2) sleep restriction, (3) stimulus control, (4) cognitive restructuring (targeting sleep-related dysfunctional cognitions), (5) structured worry time, and (6) relapse prevention (appendix pp 2). Participants had access to the e-CBT-I intervention for 12 weeks, allowing them additional time to complete the intervention in case they were unable to completed it within the initial 6-week period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Major Depressive Disorder | Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI). | Posted | Count of Participants | Participants | Up to 12-month follow-up |
|
Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I) | The e-CBT-I intervention is a digital, self-paced, and interactive insomnia intervention program delivered through smartphone application (esleep: Android: https://sd-oss-cdn.sumian.com/apk/eSleep\_1.0.3-release.apk; iOS: Apple App store) that was developed by our research team (Li Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR), and was modified and issued by BestCare & SuMian BioTech Co, Ltd. The Chinese version (simplified Chinese/Mandarin) of the application was designed to adapt for the language background of the participants in China. The program is developed as based on well-established CBT-I treatment protocol and consists of six 20-30 minutes sequential modules unlocked weekly with animated elements, including (1) overview of sleep, (2) sleep restriction, (3) stimulus control, (4) cognitive restructuring (targeting sleep-related dysfunctional cognitions), (5) structured worry time, and (6) relapse prevention (appendix pp 2). Participants had access to the e-CBT-I intervention for 12 weeks, allowing them additional time to complete the intervention in case they were unable to completed it within the initial 6-week period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yun Kwok Wing | Chinese University of Hong Kong | +852 39197593 | ykwing@cuhk.edu.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2022 | Nov 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003863 | Depression |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| e-HE | Behavioral | The e-HE will be delivered in control though a mobile application (eSleep) with a personal password. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 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). | Baseline, post-intervention, 6- and 12-month follow-up |
| Hong Kong |
| Hong Kong |
| BG001 | E-based Health Education (e-HE) | The control (e-HE) condition was developed by our research team (Li Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR) and issued by BestCare & SuMian BioTech Co, Ltd. according to a psychoeducation/information approach, in order to provide the credibility of the intervention to the participants, and to control for the potential dosing effect of attention and nonspecific components (e.g., expectation and contact hours). The e-HE is a health promotion program with the same contact hours as e-CBT-I which contains information about general sleep knowledge, functions of human organs, nutrition, environmental health, brain health, identification, and treatments of common diseases, while it did not include any active insomnia and depression therapeutic components (appendix pp 2). Each module was unlocked weekly, and participants had access to the program for 12 weeks. The general sleep knowledge session was purposively added in this sleep related RCT to meet the expectation of the participants. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Insomnia Severity Index | Insomnia symptoms were 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. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire-9 | Depressive symptoms were 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | E-based Health Education (e-HE) | The control (e-HE) condition was developed by our research team (Li Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR) and issued by BestCare & SuMian BioTech Co, Ltd. according to a psychoeducation/information approach, in order to provide the credibility of the intervention to the participants, and to control for the potential dosing effect of attention and nonspecific components (e.g., expectation and contact hours). The e-HE is a health promotion program with the same contact hours as e-CBT-I which contains information about general sleep knowledge, functions of human organs, nutrition, environmental health, brain health, identification, and treatments of common diseases, while it did not include any active insomnia and depression therapeutic components (appendix pp 2). Each module was unlocked weekly, and participants had access to the program for 12 weeks. The general sleep knowledge session was purposively added in this sleep related RCT to meet the expectation of the participants. |
|
|
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | Baseline, post-session 2, post-session 4, post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | 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 |
|
|
|
| Secondary | 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. | Posted | Number | percentage of participants | Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Error | score on a scale | 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 |
|
|
|
| Other Pre-specified | Percentage of Participants With Suicidality | Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI. | Posted | Number | percentage of participants | Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up |
|
|
|
| Other Pre-specified | 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. | Not Posted | Baseline, post-intervention, 6- and 12-month follow-up | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline, post-intervention, 6- and 12-month follow-up | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline, post-intervention, 6- and 12-month follow-up | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline, post-intervention, 6- and 12-month follow-up | Participants |
| Other Pre-specified | 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). | Not Posted | Baseline, post-intervention, 6- and 12-month follow-up | Participants |
| Other Pre-specified | 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). | Not Posted | Baseline, post-intervention, 6- and 12-month follow-up | Participants |
| Other Pre-specified | 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). | Not Posted | Baseline, post-intervention, 6- and 12-month follow-up | Participants |
| Other Pre-specified | 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). | Not Posted | Baseline, post-intervention, 6- and 12-month follow-up | Participants |
| Other Pre-specified | 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). | Not Posted | Baseline, post-intervention, 6- and 12-month follow-up | Participants |
| 0 |
| 354 |
| 0 |
| 354 |
| 0 |
| 354 |
| EG001 | E-based Health Education (e-HE) | The control (e-HE) condition was developed by our research team (Li Chiu Kong Family Sleep Assessment Unit, Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR) and issued by BestCare & SuMian BioTech Co, Ltd. according to a psychoeducation/information approach, in order to provide the credibility of the intervention to the participants, and to control for the potential dosing effect of attention and nonspecific components (e.g., expectation and contact hours). The e-HE is a health promotion program with the same contact hours as e-CBT-I which contains information about general sleep knowledge, functions of human organs, nutrition, environmental health, brain health, identification, and treatments of common diseases, while it did not include any active insomnia and depression therapeutic components (appendix pp 2). Each module was unlocked weekly, and participants had access to the program for 12 weeks. The general sleep knowledge session was purposively added in this sleep related RCT to meet the expectation of the participants. | 0 | 354 | 0 | 354 | 0 | 354 |
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D016728 | Self-Injurious Behavior |
| Post-session 4 |
|
| Post-intervention |
|
| 6-month |
|
| 12-month |
|
| Post-session 4 |
|
| Post-intervention |
|
| 6-month |
|
| 12-month |
|
| 12-month |
|
| Post-session 4 |
|
| Post-intervention |
|
| 6-month |
|
| 12-month |
|
| 12-month |
|