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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
Hong Kong1 site
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: e-HE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted28 Aug 2019
- Study start5 Sep 2019
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Sixth Hospital
- Responsible party
- Principal investigator, Professor Wing Yun Kwok, Chinese University of Hong Kong
- Investigators
- Yun Kwok Wing, MBChB, Principal investigator, Chinese University of Hong KongLin Lu, PhD, Principal investigator, Peking University Sixth HospitalShirley Xin Li, PhD, Study director, Hong Kong UniversityJihui Zhang, PhD, Study director, Chinese University of Hong KongLe Shi, PhD, Study director, Peking University Sixth Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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