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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 18 Years |
| Sex | All |
| Enrollment | 343 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Status | Recruiting |
| Started | April 20, 2024 |
| Main results expected | May 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT06358898 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
An online program to help adults with sleep difficulties
This study tests an online program designed to help adults with sleep problems like insomnia and anxiety to see if it can improve their sleep and overall well-being.
-
Mindfulness-based sleep program for pregnant women to prevent depression
This study is testing a mindfulness-based sleep program to see if it can help pregnant women with insomnia reduce their risk of depression.
-
Investigating how sleep therapy affects emotional regulation
This study is testing if sleep therapy can help improve emotional control and reduce feelings of depression in people struggling with insomnia.
-
Improving sleep for better mental health and school performance in teenagers
This study tests two school programs designed to help teenagers aged 13-19 improve their sleep to see if it can boost their mental health and school performance.
-
Auricular acupuncture for treating depression during the Covid-19 pandemic
This study is testing if auricular acupuncture can help university students with moderate depression feel better during the Covid-19 pandemic.
-
Comparing two therapies for insomnia in veterans with traumatic brain injury
This study is testing whether online therapy for insomnia or mindfulness techniques can help veterans with brain injuries sleep better and feel less depressed.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.