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InsomniaNCT04069247

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

A study testing e-CBT-I and e-HE in people with Insomnia, run by Chinese University of Hong Kong at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 25 years
Conditions the study is for
Insomnia
What is being tested?
e-CBT-I and e-HE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
708 participants
Where
2 sitesin 2 countries
Study dates
5 Sep 2019to 18 Jan 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

China1 site

  • Peking University Sixth Hospital

    Beijing

Other trials in China

Hong Kong1 site

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

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Effectiveness of E-based Cognitive Behavioral Therapy for Insomnia on Improving Mental Health in Chinese Youths With Insomnia: a Large-scale Randomized Control Trial

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.

Read the 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 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.

Conditions
Insomnia
Being tested
e-CBT-I, e-HE
Keywords
cognitive behavioral therapy, insomnia, depression, suicide, youth
Medical subject headings
Sleep Initiation and Maintenance Disorders, Depression, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-CBT-IBehavioural

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

  • e-HEBehavioural

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

Study groups in NCT04069247
Study groupRoleWhat they receive
E-based cognitive behavioral therapy for insomnia (e-CBT-I)ExperimentalThe 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.
Receives: Behavioral: e-CBT-I
E-based health education (e-HE)Active comparatorThe 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.
Receives: Behavioral: e-HE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Major Depressive Disorder

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

    Measured: Up to 12-month follow-up

Secondary outcomes (3)

  1. Change of Depressive Symptoms

    Depressive symptoms will be measured by Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a commonly used self-administered questionnaire to assess depressive symptoms and severity, with a higher total score suggesting more severe depressive symptoms. Scores range from 0 to 27.

    Measured: Baseline, post-session 2, post-session 4, post-intervention (week 7/at the conclusion of last session), 6- and 12-month follow-up

  2. Change of Insomnia Symptoms

    Insomnia symptoms will be measured by Insomnia Severity Index (ISI). ISI is a seven-item self-report measure designed to assess the nature, severity and impact of insomnia, with a higher total score suggesting more severe insomnia symptoms. Scores range from 0 to 28.

    Measured: 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

  3. Percentage of Participants in Remission of Insomnia Disorder

    Insomnia disorder will be confirmed by International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start5 Sep 2019
  3. Primary completion18 Jan 2024
  4. Study completion18 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
708 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04069247
Sponsor's protocol ID
2019.044
Status last verified
Nov 2024
First submitted
15 Aug 2019
Last updated
9 Jan 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39836656

Questions about this trial

What is this clinical trial studying?

A study testing e-CBT-I and e-HE in people with Insomnia, run by Chinese University of Hong Kong at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Major Depressive Disorder (time frame: Up to 12-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04069247, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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