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

Condition(s) studied

Investigational drug(s) / intervention(s)

Mindfulness Intervention for Emotional Distress: MIED is a psychological intervention program based on "Mindfulness-Based Stress Reduction" (MBSR) and the "Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP), proposed by one of our authors. It includes a psychological diamond model of emotional distress and core intervention strategies (Liu, 2024). This program, in the form of mental health education courses, is suitable for patients with emotional disorders such as anxiety and depression. It has shown good effects in alleviating emotional distress in a series of preliminary studies (Ju et al., 2022; Li et al., 2023; Li et al., 2025; Wang et al., 2024). In this study, the intervention mainly adopts a step-care model, dynamically adjusting the intensity of the intervention according to the patient's recovery progress. All intervention content revolves around the four core transdiagnostic mechanisms of the MIED psychological diamond model and their corresponding core intervention strategies.

Study 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

Primary outcome measure(s)

• Time to Reliable Recovery — 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
  According to the standard definition of the IAPT (Improving Access to Psychological Therapies) system (El Baou et al., 2023; Gyani et al., 2013), reliable recovery requires meeting both of the following conditions simultaneously: (1) Reliable improvement: a decrease in PHQ-9 score of ≥6 points, or a decrease in GAD-7 score of ≥4 points, compared to baseline; (2) Symptoms below clinical thresholds: PHQ-9 \< 10 and GAD-7 \< 8. Time to reliable recovery is defined as the time from randomization to the first point at which both of the above criteria are met.

Trial sites (1)

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