Digital stepped-care mindfulness program for emotional disorders
Effectiveness and Cost-effectiveness of a Digital Stepped-care Mindfulness Intervention for Recovery From Emotional Disorders: a Multicentre Pragmatic Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 464 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07458100 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing
- 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
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.