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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Age: 18-65 years. 2. Diagnosed with an emotional disorder by a psychiatrist (distinguishing primary and comorbid diagnoses during assessment) and meeting criteria on the Mini-International Neuropsychiatric Interview (MINI), 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). 3. Symptom severity meeting the threshold: PHQ-9 score ≥10 or GAD-7 score ≥8. Who Should NOT Join This Trial: 1. Current diagnosis of psychotic disorders or bipolar disorder. 2. Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders. 3. Current suicide risk (moderate or higher suicide risk on the MINI suicide module). 4. Antisocial personality disorder. 5. Severe medical illnesses that may affect intervention participation or require recent hospitalization. 6. Previous participation in a systematic 8-week mindfulness course. 7. Inability to access the internet. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age: 18-65 years. 2. Diagnosed with an emotional disorder by a psychiatrist (distinguishing primary and comorbid diagnoses during assessment) and meeting criteria on the Mini-International Neuropsychiatric Interview (MINI), 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). 3. Symptom severity meeting the threshold: PHQ-9 score ≥10 or GAD-7 score ≥8. Exclusion Criteria: 1. Current diagnosis of psychotic disorders or bipolar disorder. 2. Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders. 3. Current suicide risk (moderate or higher suicide risk on the MINI suicide module). 4. Antisocial personality disorder. 5. Severe medical illnesses that may affect intervention participation or require recent hospitalization. 6. Previous participation in a systematic 8-week mindfulness course. 7. Inability to access the internet.

Treatments Being Tested

BEHAVIORAL

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.

Locations (1)

Peking University
Beijing, China