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

Not Applicable

Completed

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.

Recruitment & Eligibility

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 prominent suicidality (suicide plans and suicide attempts) measured by MINI via telephone interview
A reported diagnosis of psychosis, schizophrenia, bipolar disorder, or neurodevelopmental disorders
Medical conditions that could cause poor sleep quality and sleep continuity disruption, such as eczema
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 MDD or a prior episode of MDD within past two months measured by MINI via telephone interview
Women during pregnancy or lactation
Currently receiving psychological treatment for insomnia provided by a psychologist and/or pharmacological treatment for depression

Arm && Interventions

Group	Intervention	Description
E-based cognitive behavioral therapy for insomnia (eCBT-I)	ECBT-I	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.
Health education (HE)	HE	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Locations (2): Peking University Sixth Hospital
🇨🇳
Beijing, China
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
🇭🇰
Hong Kong, Hong Kong