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

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.

Conditions

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

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.

Sponsors & Collaborators

• WU'AN FIRST PEOPLE'S HOSPITAL

  collaborator UNKNOWN

• Xi'an Mental Health Center

  collaborator UNKNOWN

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• The Guangxi Zhuang Autonomous Region Brain Hospital

  collaborator UNKNOWN

• DONG GUAN SEVENTH PEOPLE'S HOSPITAL

  collaborator UNKNOWN

• Affiliated Mental Health Center of Kunming Medical University

  collaborator UNKNOWN

• People's Hospital of Zhengzhou University

  collaborator OTHER

• The Affiliated Brain Hospital of Guangzhou Medical University

  collaborator UNKNOWN

• THE SIXTH AFFILIATED HOSPITAL OF GUANGDONG PHARMACEUTICAL UNIVERSITY

  collaborator UNKNOWN

• Xiamen Medical College Affiliated Xian Yue Hospital

  collaborator UNKNOWN

• Peking University

  lead OTHER

Principal Investigators

• Xinghua Liu · School of Psychological and Cognitive Sciences,Peking University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-23

Primary Completion

2028-05-31

Completion

2028-05-31

Countries

• China

Study Locations