Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Digital stepped-care mindfulness program for emotional disorders

Official title: Effectiveness and Cost-effectiveness of a Digital Stepped-care Mindfulness Intervention for Recovery From Emotional Disorders: a Multicentre Pragmatic Randomized Controlled Trial

Run by Peking University · NCT07458100 · Data updated 2026-11-12

This project tests whether adding an online mindfulness program to usual care helps adults (18–65) with depression, anxiety, OCD, or PTSD recover faster and stay well longer.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment600 (estimated)
SponsorPeking University
Academic / other
Locations1 site (Beijing)
StatusRecruiting
StartedMarch 23, 2026
Main results expectedMay 2028
Study endsMay 2028
Registry record updatedNovember 10, 2026
Trial IDNCT07458100 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 diagnosed with an emotional disorder who have at least moderate symptoms (PHQ-9 ≥10 or GAD-7 ≥8) and can access the internet are ideal candidates.

Probably not a fit

Patients with current psychotic or bipolar disorders, active suicide risk, severe cognitive or medical impairments, substance use disorders, prior completion of an 8-week mindfulness course, or inability to use the internet are unlikely to benefit from this intervention.

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

What this trial studies

This randomized interventional trial compares usual care alone to usual care plus a digital stepped-care mindfulness program in adults with emotional disorders. The intervention group attends eight weekly two-hour online group mindfulness sessions and completes 49 days of guided practice via a WeChat mini-program, with additional stepped-care for non-responders. Participants are followed for two years to track clinical recovery and health-care use. Outcomes include symptom recovery over time and a formal cost-effectiveness analysis versus usual care.

Why it matters

Potential benefit: If successful, the program could speed and sustain recovery while lowering overall treatment costs by providing a scalable complement to usual care.

How similar studies have gone: Previous meta-analyses show moderate symptom improvements from mindfulness-based and transdiagnostic interventions, but long-term stepped-care digital programs combining group sessions, app-based practice, and cost-effectiveness analyses are less well tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age: 18-65 years.
2. Diagnosed with an emotional disorder by a outpatient psychiatrist, including depressive disorders, anxiety disorders (e.g., generalized anxiety disorder, panic disorder, agoraphobia, social anxiety disorder), obsessive-compulsive disorder, post-traumatic stress disorder, and eating disorders (e.g., anorexia nervosa, bulimia nervosa).
3. Symptom severity meeting the threshold: PHQ-9 score ≥10 or GAD-7 score ≥8.

Exclusion Criteria:

1. Current diagnosis of psychotic disorders or bipolar disorder.
2. Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders.
3. Current suicide risk (PHQ-9 item 9 score \>2).
4. Antisocial personality disorder.
5. Severe medical illnesses that may affect intervention participation or require recent hospitalization.
6. Previous participation in a systematic 8-week mindfulness course.
7. Inability to access the internet.

Where it's running

  • Peking University
    Beijing, China
    Recruiting

Study contacts

  • Principal investigator: Xinghua Liu — School of Psychological and Cognitive Sciences,Peking University
  • Study coordinator: Dongyang Chen
  • Email: psychen@stu.pku.edu.cn
  • Phone: +8618810673387

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.