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

Sponsor
Peking University
Study ID
NCT07458100
Status
Recruiting
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Conditions

  • Anxiety Disorders
  • Depressive Disorder
  • Eating Disorders
  • Emotional Disorders
  • Obsessive-Compulsive Disorder
  • Post-Traumatic Stress Disorder, PTSD

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Mindfulness Intervention for Emotional Distress — BEHAVIORAL
    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 Details

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 Dates

First listed
Mar 9, 2026
Start date
Mar 23, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
464 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Time to Reliable Recovery [ Time Frame: 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 ]

Central Contacts

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