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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04069247
• Other study ID #: 2019.044
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: May 30, 2024

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Yun Kwok Wing, MBChB
• Phone: +852 39197593
• Email: ykwing[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to conduct a randomized control trial to validate the treatment effect of e-based cognitive behavioral therapy for Insomnia (eCBT-I) on insomnia disorder, and explore whether eCBT-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 eCBT-I on prevention of depression and suicide.

Description:

Previous studies have documented the associations of insomnia with depression and suicide. Currently, researchers have done considerable work to investigate whether eCBT-I could be effective in improving psychological well-being for adults, and previous studies have confirmed that eCBT-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 eCBT-I might affect mental health, and whether eCBT-I could reduce the risk of depression and suicide.

This study will be the first specifically designed investigation of the preventive effects of eCBT-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 eCBT-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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1750
• Est. completion date: May 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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 suicide plans and suicide attempts measured by MINI via telephone interview

3. A reported diagnosis of psychosis, schizophrenia, bipolar disorders, or neurodevelopmental disorders

4. Medical conditions that could cause poor sleep quality and sleep continuity disruption, such as eczema, gastro-oesophageal and reflux disease

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 major depressive disorder measured by MINI via telephone interview

7. Women during pregnancy or lactation

8. Currently receiving psychological treatment for insomnia provided by a psychologist

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• ECBT-I
The eCBT-I will be delivered through a mobile application (eSleep) with a personal password.
• HE
The HE will be delivered in control though a mobile application (eSleep) with a personal password.

Locations

Country	Name	City	State
China	Peking University Sixth Hospital	Beijing
Hong Kong	Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Peking University Sixth Hospital

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Other	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-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Other	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-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Other	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-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Other	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, week 3/at the conclusion of session 2, week 5/at the conclusion of session 4, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Other	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, week 3/at the conclusion of session 2, week 5/at the conclusion of session 4, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Other	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, week 3/at the conclusion of session 2, week 5/at the conclusion of session 4, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Other	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, week 3/at the conclusion of session 2, week 5/at the conclusion of session 4, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Other	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, week 3/at the conclusion of session 2, week 5/at the conclusion of session 4, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Primary	Remission rate 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-treatment (week 7/at the conclusion of last session)
Primary	Remission rate 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.	6-month follow-up
Primary	Remission rate 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.	12-month follow-up
Primary	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, week 3/at the conclusion of session 2, week 5/at the conclusion of session 4, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Primary	New incidence of major depressive disorder	Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).	Post-treatment (week 7/at the conclusion of last session)
Primary	New incidence of major depressive disorder	Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).	6-month follow-up
Primary	New incidence of major depressive disorder	Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).	12-month follow-up
Primary	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, week 3/at the conclusion of session 2, week 5/at the conclusion of session 4, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up
Secondary	New incidence of suicidality	Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI.	Post-treatment (week 7/at the conclusion of last session)
Secondary	New incidence of suicidality	Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI.	6-month follow-up
Secondary	New incidence of suicidality	Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI.	12-month follow-up
Secondary	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, week 3/at the conclusion of session 2, week 5/at the conclusion of session 4, post-treatment (week 7/at the conclusion of last session), 6-month follow-up and 12-month follow-up