Recruiting

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

ClinicalTrials.gov IDNCT07458100

PhaseNA

Enrollment464

SponsorPeking University

Age18 Years – 65 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

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.

Primary outcomes

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)

Eligibility information

Inclusion Criteria: 1. Age: 18-65 years. 2. 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). 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 (PHQ-9 item 9 score \>2). 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.

Study locations

Peking University, Beijing, China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-22.