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

Recruiting now · Not applicable

Conditions studied: Emotional Disorders, Depressive Disorder, Anxiety Disorders, Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder, PTSD, Eating Disorders

In brief

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.

Key facts

Study ID

NCT07458100

Run by

Peking University

People needed

464

Starts

2026-03-23

Expected to finish

2028-05-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18-65 years.
• 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).
• Symptom severity meeting the threshold: PHQ-9 score ≥10 or GAD-7 score ≥8.

You may not qualify if…

• 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 (PHQ-9 item 9 score >2).
• Antisocial personality disorder.
• Severe medical illnesses that may affect intervention participation or require recent hospitalization.
• Previous participation in a systematic 8-week mindfulness course.
• Inability to access the internet.

Where it is running

• Peking University — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.