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

The Chinese University of Hong Kong

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: e-HE; Behavioral: e-CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT04069247

2019.044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 708 patients

Sex: All

Ages: 15 to 25 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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708 participants in 2 patient groups

E-based cognitive behavioral therapy for insomnia (e-CBT-I)

Experimental group

Description:

The e-CBT-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 e-CBT-I treatment for 12 weeks.

Treatment:

Behavioral: e-CBT-I

E-based health education (e-HE)

Active Comparator group

Description:

The e-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.

Treatment:

Behavioral: e-HE