Trial Outcomes & Findings for Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia (NCT NCT04069247)
NCT ID: NCT04069247
Last Updated: 2025-01-09
Results Overview
Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
708 participants
Primary outcome timeframe
Up to 12-month follow-up
Results posted on
2025-01-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
354
|
354
|
|
Overall Study
COMPLETED
|
315
|
319
|
|
Overall Study
NOT COMPLETED
|
39
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia
Baseline characteristics by cohort
| Measure |
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)
n=354 Participants
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.
|
E-based Health Education (e-HE)
n=354 Participants
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.
|
Total
n=708 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
22.2 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
22.1 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
407 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
354 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
708 Participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
18 participants
n=5 Participants
|
23 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
China
|
336 participants
n=5 Participants
|
331 participants
n=7 Participants
|
667 participants
n=5 Participants
|
|
Insomnia Severity Index
|
18.3 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
18.3 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
18.3 units on a scale
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Patient Health Questionnaire-9
|
12.1 units on a scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 3.4 • n=7 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12-month follow-upMajor depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).
Outcome measures
| Measure |
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)
n=354 Participants
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.
|
E-based Health Education (e-HE)
n=354 Participants
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.
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|---|---|---|
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Number of Participants With Major Depressive Disorder
|
37 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Baseline, post-session 2, post-session 4, post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-upDepressive 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.
Outcome measures
| Measure |
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)
n=354 Participants
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.
|
E-based Health Education (e-HE)
n=354 Participants
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.
|
|---|---|---|
|
Change of Depressive Symptoms
Post-intervention
|
5.1 score on a scale
Standard Error 0.2
|
6.2 score on a scale
Standard Error 0.2
|
|
Change of Depressive Symptoms
6-month
|
5.4 score on a scale
Standard Error 0.2
|
6.3 score on a scale
Standard Error 0.2
|
|
Change of Depressive Symptoms
Baseline
|
12.1 score on a scale
Standard Error 0.2
|
12.1 score on a scale
Standard Error 0.2
|
|
Change of Depressive Symptoms
Post-session 2
|
7.6 score on a scale
Standard Error 0.2
|
7.7 score on a scale
Standard Error 0.2
|
|
Change of Depressive Symptoms
Post-session 4
|
6.1 score on a scale
Standard Error 0.2
|
7.0 score on a scale
Standard Error 0.2
|
|
Change of Depressive Symptoms
12-month
|
5.5 score on a scale
Standard Error 0.2
|
6.0 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 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-upInsomnia 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.
Outcome measures
| Measure |
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)
n=354 Participants
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.
|
E-based Health Education (e-HE)
n=354 Participants
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.
|
|---|---|---|
|
Change of Insomnia Symptoms
Baseline
|
18.3 score on a scale
Standard Error 0.2
|
18.3 score on a scale
Standard Error 0.2
|
|
Change of Insomnia Symptoms
Post-session 2
|
11.5 score on a scale
Standard Error 0.2
|
12.1 score on a scale
Standard Error 0.2
|
|
Change of Insomnia Symptoms
Post-session 4
|
9.0 score on a scale
Standard Error 0.2
|
10.7 score on a scale
Standard Error 0.2
|
|
Change of Insomnia Symptoms
Post-intervention
|
7.3 score on a scale
Standard Error 0.2
|
9.3 score on a scale
Standard Error 0.2
|
|
Change of Insomnia Symptoms
6-month
|
7.2 score on a scale
Standard Error 0.2
|
8.4 score on a scale
Standard Error 0.2
|
|
Change of Insomnia Symptoms
12-month
|
7.3 score on a scale
Standard Error 0.2
|
8.2 score on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-upInsomnia 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.
Outcome measures
| Measure |
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)
n=354 Participants
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.
|
E-based Health Education (e-HE)
n=354 Participants
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.
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|---|---|---|
|
Percentage of Participants in Remission of Insomnia Disorder
Post-intervention
|
52 percentage of participants
|
28 percentage of participants
|
|
Percentage of Participants in Remission of Insomnia Disorder
6-month
|
56 percentage of participants
|
44 percentage of participants
|
|
Percentage of Participants in Remission of Insomnia Disorder
12-month
|
57 percentage of participants
|
48 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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-upAnxiety 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.
Outcome measures
| Measure |
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)
n=354 Participants
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.
|
E-based Health Education (e-HE)
n=354 Participants
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.
|
|---|---|---|
|
Change of Anxiety Symptoms
Baseline
|
7.7 score on a scale
Standard Error 0.2
|
7.9 score on a scale
Standard Error 0.2
|
|
Change of Anxiety Symptoms
Post-session 2
|
5.8 score on a scale
Standard Error 0.2
|
6.2 score on a scale
Standard Error 0.2
|
|
Change of Anxiety Symptoms
Post-session 4
|
4.6 score on a scale
Standard Error 0.2
|
5.6 score on a scale
Standard Error 0.2
|
|
Change of Anxiety Symptoms
Post-intervention
|
4.0 score on a scale
Standard Error 0.2
|
4.9 score on a scale
Standard Error 0.2
|
|
Change of Anxiety Symptoms
6-month
|
4.3 score on a scale
Standard Error 0.2
|
5.0 score on a scale
Standard Error 0.2
|
|
Change of Anxiety Symptoms
12-month
|
4.4 score on a scale
Standard Error 0.2
|
4.8 score on a scale
Standard Error 0.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-upSuicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI.
Outcome measures
| Measure |
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)
n=354 Participants
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.
|
E-based Health Education (e-HE)
n=354 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Suicidality
Post-intervention
|
15 percentage of participants
|
15 percentage of participants
|
|
Percentage of Participants With Suicidality
6-month
|
19 percentage of participants
|
13 percentage of participants
|
|
Percentage of Participants With Suicidality
12-month
|
14 percentage of participants
|
15 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention, 6- and 12-month follow-upSuicidal 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention, 6- and 12-month follow-upDaytime 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention, 6- and 12-month follow-upSleep-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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention, 6- and 12-month follow-upCircadian 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention, 6- and 12-month follow-upTIB 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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention, 6- and 12-month follow-upTST 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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention, 6- and 12-month follow-upSOL 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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention, 6- and 12-month follow-upWASO 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).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, post-intervention, 6- and 12-month follow-upSE 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).
Outcome measures
Outcome data not reported
Adverse Events
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
E-based Health Education (e-HE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place