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

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.

NCT Number	NCT07458100
Lead Sponsor	Peking University Collaborators: WU'AN FIRST PEOPLE'S HOSPITAL, Xi'an Mental Health Center, The Second Hospital of Anhui Medical University, The Guangxi Zhuang Autonomous Region Brain Hospital, DONG GUAN SEVENTH PEOPLE'S HOSPITAL, Affiliated Mental Health Center of Kunming Medical University, People's Hospital of Zhengzhou University, The Affiliated Brain Hospital of Guangzhou Medical University, THE SIXTH AFFILIATED HOSPITAL OF GUANGDONG PHARMACEUTICAL UNIVERSITY, Xiamen Medical College Affiliated Xian Yue Hospital
Conditions	Emotional Disorders, Depressive Disorder, Anxiety Disorders, Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder, PTSD, Eating Disorders
Enrollment	464 participants
Start Date	2026-03-23
Primary Completion	2028-05 (estimated)
Study Completion	2028-05 (estimated)
Updated on ClinicalTrials.gov	2026-04-21