Clinical trial Recruiting at 1 site Interventional Ages 12 to 18

Digital therapy to improve sleep and mood in adolescents

Official title: Effect of a Smartphone-based, Mood-enhanced Cognitive Behavioral Therapy for Insomnia in Adolescents At Risk of Depression: A Cluster Randomized Trial

Run by Chinese University of Hong Kong · NCT06358898 · Data updated 2026-11-12

This study is testing a new online therapy for sleep problems to see if it can also help teenagers aged 12-18 who are dealing with both insomnia and depression feel better.

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Quick facts

Study typeInterventional
Ages12 Years to 18 Years
SexAll
Enrollment343 (estimated)
SponsorChinese University of Hong Kong
Academic / other
Locations1 site (Shatin, New Territories)
StatusRecruiting
StartedApril 20, 2024
Main results expectedMay 31, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 10, 2025
Trial IDNCT06358898 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are Chinese adolescents aged 12-18 who have clinically significant insomnia and depressive symptoms.

Probably not a fit

Patients with severe suicidality, psychotic disorders, or other significant sleep disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a digitally delivered, mood-enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) compared to standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms among adolescents aged 12-18. The research focuses on adolescents who experience both insomnia and depression, a common yet challenging combination to treat. By utilizing a digital platform, the study seeks to provide accessible treatment options while examining the sustained effects of these interventions on mood outcomes. The study will assess participants' sleep and mood improvements through validated measures.

Why it matters

Potential benefit: If successful, this approach could provide an effective non-pharmacological treatment for adolescents struggling with both insomnia and depression.

How similar studies have gone: While there is emerging evidence supporting the use of CBT for treating insomnia and depression in adults, this specific approach in adolescents is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Department of Psychiatry, the Chinese University of Hong Kong
    Shatin, New Territories, Hong Kong
    Recruiting

Study contacts

  • Principal investigator: Rachel Ngan Yin Chan, PhD — Department of Psychiatry, the Chinese University of Hong Kong
  • Study coordinator: Rachel Ngan Yin Chan, PhD
  • Email: rachel.chan@cuhk.edu.hk
  • Phone: 39710548

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.