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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University

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.

Eligibility criteria

Qualifiers

Age: 18-65 years.

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).

Symptom severity meeting the threshold: PHQ-9 score ≥10 or GAD-7 score ≥8.

Disqualifiers

Current diagnosis of psychotic disorders or bipolar disorder.

Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders.

Current suicide risk (PHQ-9 item 9 score >2).

Antisocial personality disorder.

Trial design

Treatments tested in this trial

  • Mindfulness Intervention for Emotional Distress

Treatment groups

464 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Peking University

Lead sponsor

WU'AN FIRST PEOPLE'S HOSPITAL

Collaborator

Xi'an Mental Health Center

Collaborator

The Second Hospital of Anhui Medical University

Collaborator

The Guangxi Zhuang Autonomous Region Brain Hospital

Collaborator

DONG GUAN SEVENTH PEOPLE'S HOSPITAL

Collaborator

Affiliated Mental Health Center of Kunming Medical University

Collaborator

People's Hospital of Zhengzhou University

Collaborator

The Affiliated Brain Hospital of Guangzhou Medical University

Collaborator

THE SIXTH AFFILIATED HOSPITAL OF GUANGDONG PHARMACEUTICAL UNIVERSITY

Collaborator

Xiamen Medical College Affiliated Xian Yue Hospital

Collaborator