The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders (NCT07458100) | Clinical Trial Compass
RecruitingNot Applicable
The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders
China464 participantsStarted 2026-03-23
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Current diagnosis of psychotic disorders or bipolar disorder.
. Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Reliable Recovery
Timeframe: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention