Actively Recruiting
The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders
Led by Peking University · Updated on 2026-04-21
464
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
Sponsors
P
Peking University
Lead Sponsor
W
WU'AN FIRST PEOPLE'S HOSPITAL
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the effectiveness and cost-effectiveness of a digital mindfulness-based intervention in adults (aged 18-65) diagnosed with emotional disorders like depression or anxiety. The main questions it aims to answer are: * Does adding a digital mindfulness intervention to usual care help people recover from emotional disorders faster and more sustainably over two years? * Is this combined approach more cost-effective than usual care alone? Researchers will compare the group receiving the digital mindfulness intervention plus their usual treatment to the group receiving only their usual treatment to see if the intervention leads to better long-term recovery and represents good value for money. Participants in the intervention group will: * Attend eight weekly 2-hour online group mindfulness sessions. * Use a WeChat mini-program for 49 days of guided mindfulness exercises and daily tasks. * Patients who have not achieved reliable recovery after group retraining voluntarily participate in individual UP\&MIED counseling. * Complete regular questionnaires and interviews over two years to track their progress. All participants will continue to receive their usual medical care from their doctors throughout the study.
CONDITIONS
Official Title
The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosed by an outpatient psychiatrist with an emotional disorder including depressive disorder, anxiety disorders (e.g., generalized anxiety disorder, panic disorder, agoraphobia, social anxiety disorder), obsessive-compulsive disorder, post-traumatic stress disorder, or eating disorders (e.g., anorexia nervosa, bulimia nervosa)
- Symptom severity meeting thresholds: PHQ-9 score of 10 or higher or GAD-7 score of 8 or higher
You will not qualify if you...
- Current diagnosis of psychotic disorders or bipolar disorder
- Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders
- Current suicide risk with PHQ-9 item 9 score greater than 2
- Diagnosis of antisocial personality disorder
- Severe medical illnesses affecting participation or requiring recent hospitalization
- Previous participation in a systematic 8-week mindfulness course
- Inability to access the internet
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University
Beijing, China
Actively Recruiting
Research Team
D
Dongyang Chen
CONTACT
E
Elena Gomzyakova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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