Digital cognitive behavioral therapy for depression
Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study
This project will test a self-developed mobile app that delivers eight weeks of AI-guided digital CBT with weekly lessons and homework for people aged 14–60 who have depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 325 (estimated) |
| Ages | 14 Years to 60 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06831435 on ClinicalTrials.gov |
What this trial studies
Researchers will deliver an 8-week cognitive behavioral therapy program through a self-developed mobile applet, with weekly sessions that include AI-guided coursework and homework created by psychotherapists. The project is set up as a real-world interventional study enrolling patients with HAMD scores ≥14 and excludes those with severe suicidal tendencies per MADRS item 10. In addition to symptom outcomes, the protocol includes exploration of genetic and neuroimaging correlates to understand biological mechanisms. All clinical visits and assessments are conducted at Peking University Sixth Hospital in Beijing.
Who should consider this trial
Good fit: Ideal candidates are people aged 14–60 with a HAMD score of 14 or higher who can provide informed consent (or whose guardian can consent if they are minors) and can attend visits at the study site.
Not a fit: People with severe suicidal tendencies or who require immediate inpatient psychiatric care are unlikely to benefit from this outpatient digital CBT program.
Why it matters
Potential benefit: If successful, this app could reduce depressive symptoms and increase access to therapist-informed CBT through a scalable, home-based program.
How similar studies have performed: Digital CBT has demonstrated benefit for mild-to-moderate depression in multiple prior trials, but AI-guided applets and the added genetic/neuroimaging components are less established in real-world settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 14-60 years (including 14 and 60), no gender restriction; 2. HAMD \>= 14; 3. Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors. Exclusion Criteria: * Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).
Where this trial is running
Beijing, Beijing Municipality
- Peking University Sixth Hostipal — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Weihua Yue
- Email: dryue@bjmu.edu.cn
- Phone: 86-010-82805307
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.