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

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    1750
  • sponsor
    Chinese University of Hong Kong
Updated on 16 February 2022
depression
behavior therapy
psychiatric disorder
cognitive therapy
poor sleep
cognitive behavioral therapy for insomnia

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.

Details
Condition Insomnia
Treatment HE, ECBT-I
Clinical Study IdentifierNCT04069247
SponsorChinese University of Hong Kong
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

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
The presence of current major depressive disorder measured by MINI via telephone interview
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
Women during pregnancy or lactation
Currently receiving psychological treatment for insomnia provided by a psychologist
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