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

NCT04069247 | Completed Results

• 1 other identifier: 2019.044
• Study Type: interventional
• Target: 708
• Locations: 2 countries
• Sites: 2

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.

Conditions

Insomnia

Keywords

cognitive behavioral therapy; insomnia; depression; suicide; youth

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Major Depressive Disorder

  Major depressive disorder will be confirmed by Mini International Neuropsychiatric Interview (MINI).

  Up to 12-month follow-up

Secondary Outcomes (3)

• 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

• 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

• Percentage of Participants in Remission of Insomnia Disorder

  Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up

Other Outcomes (11)

• Change of Anxiety 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

• Percentage of Participants With Suicidality

  Post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up

• Change of Suicidal Ideation

  Baseline, post-intervention, 6- and 12-month follow-up

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: e-CBT-I

E-based health education (e-HE)

ACTIVE COMPARATOR

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.

Behavioral: e-HE

Interventions

e-CBT-I BEHAVIORAL

The e-CBT-I will be delivered through a mobile application (eSleep) with a personal password.

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

e-HE BEHAVIORAL

The e-HE will be delivered in control though a mobile application (eSleep) with a personal password.

E-based health education (e-HE)

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Peking University Sixth Hospital: collaborator

Study Sites (2)

Peking University Sixth Hospital

Beijing, China

Location

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

Hong Kong, Hong Kong

Location

Related Publications (1)

• Chen SJ, Que JY, Chan NY, Shi L, Li SX, Chan JWY, Huang W, Chen CX, Tsang CC, Ho YL, Morin CM, Zhang JH, Lu L, Wing YK. Effectiveness of app-based cognitive behavioral therapy for insomnia on preventing major depressive disorder in youth with insomnia and subclinical depression: A randomized clinical trial. PLoS Med. 2025 Jan 21;22(1):e1004510. doi: 10.1371/journal.pmed.1004510. eCollection 2025 Jan.

  PMID: 39836656 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Suicide

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Self-Injurious Behavior

Results Point of Contact

• Title: Dr. Yun Kwok Wing
• Organization: Chinese University of Hong Kong

ykwing@cuhk.edu.hk

+852 39197593

Study Officials

• Yun Kwok Wing, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Lin Lu, PhD

  Peking University Sixth Hospital

  PRINCIPAL INVESTIGATOR

• Shirley Xin Li, PhD

  Hong Kong University

  STUDY DIRECTOR

• Jihui Zhang, PhD

  Chinese University of Hong Kong

  STUDY DIRECTOR

• Le Shi, PhD

  Peking University Sixth Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 28, 2019
• Study Start: September 5, 2019
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); CN (1)