NCT06358898 Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents
| NCT ID | NCT06358898 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 343 participants |
| Start Date | 2024-04-20 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 343 participants in total. It began in 2024-04-20 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment.
Eligibility Criteria
Inclusion Criteria: 1. Chinese adolescent aged 12-18 years old 2. presence of insomnia problems as defined by insomnia severity index ≥ 9 (locally validated cut off for detecting clinical insomnia in adolescents) 3. presence of depressive problems as defined by Patient Health Questionnaire-9 (PHQ-9) using cut off of 10 for detecting clinical depression 4. ability to read and understand Chinese 5. possession of smartphone Exclusion Criteria: 1. presence of prominent suicidality (suicide plans and suicide attempts) as determined by the Mini-International Neuropsychiatric Interview (MINI) 2. a clinical diagnosis of psychosis, schizophrenia, bipolar disorders, or intellectual disability 3. presence of other sleep disorders that significantly affect sleep continuity or sleep quality (e.g. restless leg symptoms or obstructive sleep apnea syndrome) as determined by validated Diagnostic Interview for Sleep Patterns and Disorders 4. currently receiving psychological treatment for insomnia and/or pharmacological treatment for depression
Contact & Investigator
Rachel Ngan Yin Chan, PhD
PRINCIPAL INVESTIGATOR
Department of Psychiatry, the Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06358898 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06358898 currently recruiting?
Yes, NCT06358898 is actively recruiting participants. Contact the research team at rachel.chan@cuhk.edu.hk for enrollment information.
Where is the NCT06358898 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT06358898 clinical trial?
NCT06358898 is sponsored by Chinese University of Hong Kong. The principal investigator is Rachel Ngan Yin Chan, PhD at Department of Psychiatry, the Chinese University of Hong Kong. The trial plans to enroll 343 participants.
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