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

Last updated: November 25, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Completed

Phase

N/A

Condition

Insomnia

Treatment

e-HE

HE

e-CBT-I

Clinical Study ID

NCT04069247
2019.044
  • Ages 15-25
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andBehavioural Disorders

  3. The presence of moderate or severe insomnia measured by a score of 15 or above onISI

  4. The presence of subclinical depression assessed by a score of between 4 and 20 onPHQ-9

  5. Access to smartphones

  6. Ability to read and understand research protocol

Exclusion

Exclusion Criteria:

  1. Shift workers

  2. The presence of prominent suicidality (suicide plans and suicide attempts) measuredby MINI via telephone interview

  3. A reported diagnosis of psychosis, schizophrenia, bipolar disorder, orneurodevelopmental disorders

  4. Medical conditions that could cause poor sleep quality and sleep continuitydisruption, such as eczema

  5. An additional sleep disorder (other than insomnia) that may potentially contributeto a disruption in sleep continuity and quality, such as excessive sleepiness andpossible obstructive sleep apnoea

  6. The presence of current MDD or a prior episode of MDD within past two monthsmeasured by MINI via telephone interview

  7. Women during pregnancy or lactation

  8. Currently receiving psychological treatment for insomnia provided by a psychologistand/or pharmacological treatment for depression

Study Design

Total Participants: 708
Treatment Group(s): 4
Primary Treatment: e-HE
Phase:
Study Start date:
September 05, 2019
Estimated Completion Date:
January 18, 2024

Study 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.

Connect with a study center

  • Peking University Sixth Hospital

    Beijing,
    China

    Site Not Available

  • Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

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