Clinical trial Recruiting at 1 site Interventional Ages 14 to 60

Digital cognitive behavioral therapy for depression

Official title: Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study

Run by Peking University · NCT06831435 · Data updated 2026-11-12

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

Study typeInterventional
Ages14 Years to 60 Years
SexAll
Enrollment325 (estimated)
SponsorPeking University
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedNovember 13, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedDecember 15, 2025
Trial IDNCT06831435 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

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

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Peking University Sixth Hostipal
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

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.