Digital therapy to improve sleep and mood in adolescents
Effect of a Smartphone-based, Mood-enhanced Cognitive Behavioral Therapy for Insomnia in Adolescents At Risk of Depression: A Cluster Randomized Trial
NA · Chinese University of Hong Kong · NCT06358898
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 343 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT06358898 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are Chinese adolescents aged 12-18 who have clinically significant insomnia and depressive symptoms.
Not a fit: Patients with severe suicidality, psychotic disorders, or other significant sleep disorders may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shatin, New Territories
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insomnia, Depression, Adolescent