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Effectiveness and Cost-effectiveness of a Digital Stepped-care Mindfulness Intervention for Recovery From Emotional Disorders: a Multicentre Pragmatic Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University
RECRUITING
Beijing
Contact Information
Primary
Dongyang Chen
psychen@stu.pku.edu.cn
+8618810673387
Backup
Elena Gomzyakova
lenagom@stu.pku.edu.cn
+8618665380155
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2028-05
Participants
Target number of participants: 464
Treatments
Experimental: Intervention Group
Participants in the MIED group will receive an eight-week live, online group course, along with 49 days of self-guided iMIED practice delivered through a digital platform. After completing the program, participants will be offered three optional online group refresher sessions, scheduled 1, 3, and 6 months post-intervention. Some participants, based on the assessment of the group instructors, may be recommended for individual counseling sessions. After the intervention, the research team will provide participants with educational materials on medication management communication and encourage them to discuss long-term treatment plans with their attending psychiatrists, including the possibility of optimizing medication doses based on stable conditions . All medical decisions must be ultimately determined by the psychiatrist . At the same time, throughout the study, participants will go through all their treatments as usual.
No_intervention: TAU Group
Participants in the treatment as usual (TAU) group will continue to receive routine clinical treatment for emotional disorders at their respective centers, including pharmacotherapy, psychoeducation, supportive interviews, and necessary psychosocial services . Medication types, doses, and adjustments are entirely determined by clinicians based on the patient's condition. To describe treatment exposure, we will collect treatment information from patients at baseline, post-intervention, and at 6, 12, 18, and 24 months follow-up. To avoid intervention contamination, the research team will not provide any mindfulness-related materials or training to the TAU group before the trial ends. Participants are also advised to avoid participating in other 8-week mindfulness courses . If participation is necessary, relevant information will be recorded and handled sensitively in the analysis.
Sponsors
Collaborators: People's Hospital of Zhengzhou University, DONG GUAN SEVENTH PEOPLE'S HOSPITAL, The Second Hospital of Anhui Medical University, THE SIXTH AFFILIATED HOSPITAL OF GUANGDONG PHARMACEUTICAL UNIVERSITY, WU'AN FIRST PEOPLE'S HOSPITAL, Xi'an Mental Health Center, The Affiliated Brain Hospital of Guangzhou Medical University, Affiliated Mental Health Center of Kunming Medical University, The Guangxi Zhuang Autonomous Region Brain Hospital, Xiamen Medical College Affiliated Xian Yue Hospital
Leads: Peking University

This content was sourced from clinicaltrials.gov