Status:

COMPLETED

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

Lead Sponsor:

Chinese University of Hong Kong

Collaborating Sponsors:

Peking University Sixth Hospital

Conditions:

Insomnia

Eligibility:

All Genders

15-25 years

Phase:

NA

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 ...

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 impro...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 5 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 18 2024

Estimated Enrollment :

708 Patients enrolled

Trial Details

Trial ID

NCT04069247

Start Date

September 5 2019

End Date

January 18 2024

Last Update

January 9 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Peking University Sixth Hospital

Beijing, China

2

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

Hong Kong, Hong Kong