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The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders

RecruitingNAAges 18 Years - 65 YearsAllPeking University
NCT07458100 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 guid

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📋 Eligibility rules (as published)
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.
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What it tests

  • Mindfulness Intervention for Emotional Distress
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Where

1 site
Peking University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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