Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia

Effectiveness of E-based Cognitive Behavioral Therapy for Insomnia on Improving Mental Health in Chinese Youths With Insomnia: a Large-scale Randomized Control Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04069247

Enrollment

708

Registered

2019-08-28

Start date

2019-09-05

Completion date

2024-01-18

Last updated

2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

cognitive behavioral therapy, insomnia, depression, suicide, youth

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALe-CBT-I

The e-CBT-I will be delivered through a mobile application (eSleep) with a personal password.

BEHAVIORALe-HE

The e-HE will be delivered in control though a mobile application (eSleep) with a personal password.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 25 Years

Healthy volunteers

Inclusion criteria

1. Native Han youths in Hong Kong and mainland China, aged between15-25 2. A diagnosis of insomnia disorder measured by ICD-10 Classification of Mental and Behavioural Disorders 3. The presence of moderate or severe insomnia measured by a score of 15 or above on ISI 4. The presence of subclinical depression assessed by a score of between 4 and 20 on PHQ-9 5. Access to smartphones 6. Ability to read and understand research protocol

Exclusion criteria

1. Shift workers 2. The presence of prominent suicidality (suicide plans and suicide attempts) measured by MINI via telephone interview 3. A reported diagnosis of psychosis, schizophrenia, bipolar disorder, or neurodevelopmental disorders 4. Medical conditions that could cause poor sleep quality and sleep continuity disruption, such as eczema 5. An additional sleep disorder (other than insomnia) that may potentially contribute to a disruption in sleep continuity and quality, such as excessive sleepiness and possible obstructive sleep apnoea 6. The presence of current MDD or a prior episode of MDD within past two months measured by MINI via telephone interview 7. Women during pregnancy or lactation 8. Currently receiving psychological treatment for insomnia provided by a psychologist and/or pharmacological treatment for depression

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Major Depressive Disorder	Up to 12-month follow-up	Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).

Secondary

Measure	Time frame	Description
Change of Depressive Symptoms	Baseline, post-session 2, post-session 4, post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up	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.
Change of Insomnia Symptoms	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	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.
Percentage of Participants in Remission of Insomnia Disorder	Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up	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.

Other

Measure	Time frame	Description
Change of Sleep-related Thoughts and Behaviors	Baseline, post-intervention, 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.
Change of Circadian Rhythms	Baseline, post-intervention, 6- and 12-month follow-up	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.
Change of Subjective Sleep Measure (Time in Bed, TIB)	Baseline, post-intervention, 6- and 12-month follow-up	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).
Change of Anxiety Symptoms	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	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.
Change of Subjective Sleep Measure (Sleep Onset Latency, SOL)	Baseline, post-intervention, 6- and 12-month follow-up	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).
Change of Subjective Sleep Measure (Wake After Sleep Onset, WASO)	Baseline, post-intervention, 6- and 12-month follow-up	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).
Change of Subjective Sleep Measure (Sleep Efficiency, SE)	Baseline, post-intervention, 6- and 12-month follow-up	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).
Change of Subjective Sleep Measure (Total Sleep Time, TST)	Baseline, post-intervention, 6- and 12-month follow-up	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).
Percentage of Participants With Suicidality	Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up	Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI.
Change of Suicidal Ideation	Baseline, post-intervention, 6- and 12-month follow-up	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.
Change of Daytime Symptoms	Baseline, post-intervention, 6- and 12-month follow-up	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.

Countries

China, Hong Kong

Participant flow

Participants by arm

Arm	Count
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.	354
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.	354
Total	708

Baseline characteristics

Characteristic	E-based Health Education (e-HE)	Total	E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)
Age, Continuous	22.2 years STANDARD_DEVIATION 1.9	22.1 years STANDARD_DEVIATION 1.9	21.9 years STANDARD_DEVIATION 2
Insomnia Severity Index	18.3 units on a scale STANDARD_DEVIATION 2.6	18.3 units on a scale STANDARD_DEVIATION 2.7	18.3 units on a scale STANDARD_DEVIATION 2.7
Patient Health Questionnaire-9	12.1 units on a scale STANDARD_DEVIATION 3.4	12.1 units on a scale STANDARD_DEVIATION 3.3	12.1 units on a scale STANDARD_DEVIATION 3.2
Race/Ethnicity, Customized Chinese	354 Participants	708 Participants	354 Participants
Region of Enrollment China	331 participants	667 participants	336 participants
Region of Enrollment Hong Kong	23 participants	41 participants	18 participants
Sex: Female, Male Female	205 Participants	407 Participants	202 Participants
Sex: Female, Male Male	149 Participants	301 Participants	152 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 354	0 / 354
other Total, other adverse events	0 / 354	0 / 354
serious Total, serious adverse events	0 / 354	0 / 354

Outcome results

Primary

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Number of Participants With Major Depressive Disorder	37 Participants
E-based Health Education (e-HE)	Number of Participants With Major Depressive Disorder	62 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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Depressive Symptoms	Baseline	12.1 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Depressive Symptoms	Post-session 2	7.6 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Depressive Symptoms	Post-session 4	6.1 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Depressive Symptoms	Post-intervention	5.1 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Depressive Symptoms	6-month	5.4 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Depressive Symptoms	12-month	5.5 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Depressive Symptoms	6-month	6.3 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Depressive Symptoms	Baseline	12.1 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Depressive Symptoms	Post-intervention	6.2 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Depressive Symptoms	Post-session 2	7.7 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Depressive Symptoms	12-month	6.0 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Depressive Symptoms	Post-session 4	7.0 score on a scale	Standard Error 0.2

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Insomnia Symptoms	Baseline	18.3 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Insomnia Symptoms	Post-session 2	11.5 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Insomnia Symptoms	Post-session 4	9.0 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Insomnia Symptoms	Post-intervention	7.3 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Insomnia Symptoms	6-month	7.2 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Insomnia Symptoms	12-month	7.3 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Insomnia Symptoms	6-month	8.4 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Insomnia Symptoms	Baseline	18.3 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Insomnia Symptoms	Post-intervention	9.3 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Insomnia Symptoms	Post-session 2	12.1 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Insomnia Symptoms	12-month	8.2 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Insomnia Symptoms	Post-session 4	10.7 score on a scale	Standard Error 0.2

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.

Time frame: Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up

Arm	Measure	Group	Value (NUMBER)
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Percentage of Participants in Remission of Insomnia Disorder	Post-intervention	52 percentage of participants
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Percentage of Participants in Remission of Insomnia Disorder	6-month	56 percentage of participants
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Percentage of Participants in Remission of Insomnia Disorder	12-month	57 percentage of participants
E-based Health Education (e-HE)	Percentage of Participants in Remission of Insomnia Disorder	Post-intervention	28 percentage of participants
E-based Health Education (e-HE)	Percentage of Participants in Remission of Insomnia Disorder	6-month	44 percentage of participants
E-based Health Education (e-HE)	Percentage of Participants in Remission of Insomnia Disorder	12-month	48 percentage of participants

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.

Arm	Measure	Group	Value (MEAN)	Dispersion
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Anxiety Symptoms	Baseline	7.7 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Anxiety Symptoms	Post-session 2	5.8 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Anxiety Symptoms	Post-session 4	4.6 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Anxiety Symptoms	Post-intervention	4.0 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Anxiety Symptoms	6-month	4.3 score on a scale	Standard Error 0.2
E-based Cognitive Behavioral Therapy for Insomnia (e-CBT-I)	Change of Anxiety Symptoms	12-month	4.4 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Anxiety Symptoms	6-month	5.0 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Anxiety Symptoms	Baseline	7.9 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Anxiety Symptoms	Post-intervention	4.9 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Anxiety Symptoms	Post-session 2	6.2 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Anxiety Symptoms	12-month	4.8 score on a scale	Standard Error 0.2
E-based Health Education (e-HE)	Change of Anxiety Symptoms	Post-session 4	5.6 score on a scale	Standard Error 0.2

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.