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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Behavioral: ECBT-I
* Behavioral: HE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Native Han youths in Hong Kong and mainland China, aged between15-25 A diagnosis of insomnia disorder measured by ICD-10 Classification of Mental and Behavioural Disorders The presence of moderate or severe insomnia measured by a score of 15 or above on ISI The presence of subclinical depression assessed by a score of between 4 and 20 on PHQ-9 Access to smartphones Ability to read and understand research protocol Exclusion Criteria: Shift workers The presence of suicide plans and suicide attempts measured by MINI via telephone interview A reported diagnosis of psychosis, schizophrenia, bipolar disorders, or neurodevelopmental disorders Medical conditions that could cause poor sleep quality and sleep continuity disruption, such as eczema, gastro-oesophageal and reflux disease 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 The presence of current major depressive disorder measured by MINI via telephone interview Women during pregnancy or lactation Currently receiving psychological treatment for insomnia provided by a psychologist

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-based cognitive behavioral therapy for insomnia (eCBT-I)<br>The eCBT-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 eCBT-I treatment for 12 weeks. | Behavioral: ECBT-I<br>* The eCBT-I will be delivered through a mobile application (eSleep) with a personal password.<br>|
| Active Comparator: Health education (HE)<br>The HE, a psychoeducation/information-approach, also consists of six consecutive sessions which contains information about general sleep knowledge, functions of human organs, nutrition, environmental health, brain health, identification and treatments of common diseases, but the contents are not related to any active therapeutic components of cognitive behavioral therapy for insomnia (CBT-I).Participants will have access to the intervention for 12 weeks. | Behavioral: HE<br>* The HE will be delivered in control though a mobile application (eSleep) with a personal password.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| New incidence of major depressive disorder | Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI). | 6-month follow-up | 
| New incidence of major depressive disorder | Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI). | 12-month follow-up | 
| Change of depressive symptoms | Depressive symptoms will be measured by Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a commonly used self-administered questionnaire to assess depressive symptoms and severity, with a higher total score suggesting more severe depressive symptoms. Scores range from 0 to 27. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| New incidence of suicidality | Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI. | 6-month follow-up | 
| New incidence of suicidality | Suicidality which includes suicidal ideation, suicide plans and suicide attempts will be measured by MINI. | 12-month follow-up | 
| Change of anxiety symptoms | Anxiety symptoms will be measured by Generalised Anxiety Disorder 7-item (GAD-7). GAD-7 is a self-report measure of anxiety severity, with a higher total score suggesting more severe anxiety symptoms. Scores range from 0 to 21. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive behavioral therapy, insomnia, depression, suicide, youth