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.
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.
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.
Parallel
Mindfulness Intervention for Emotional Distress
BehavioralMIED 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.
Time to Reliable Recovery
According to the standard definition of the IAPT (Improving Access to Psychological Therapies) system (El Baou et al., 2023; Gyani et al., 2013), reliable recovery requires meeting both of the following conditions simultaneously: (1) Reliable improvement: a decrease in PHQ-9 score of ≥6 points, or a decrease in GAD-7 score of ≥4 points, compared to baseline; (2) Symptoms below clinical thresholds: PHQ-9 \< 10 and GAD-7 \< 8. Time to reliable recovery is defined as the time from randomization to the first point at which both of the above criteria are met.
Time to relapse
Time to relapse is defined as the time from achieving reliable recovery to the point at which, at any follow-up assessment, either of the following criteria is met: a PHQ-9 score ≥ 10 or a GAD-7 score ≥ 8
Rate of reliable improvement
Reliable improvement is a decrease in PHQ-9 score of ≥6 points, or a decrease in GAD-7 score of ≥4 points, compared to baseline. The rate of reliable improvement was calculated at each assessment time point.
Rate of reliable recovery
Reliable recovery requires meeting both of the following conditions simultaneously: (1) Reliable improvement (2) Symptoms below clinical thresholds: PHQ-9 \< 10 and GAD-7 \< 8. The rate of reliable recovery was calculated at each assessment time point.
Deterioration rate
Deterioration is defined according to IAPT criteria as a clinically significant worsening from baseline, operationalized as: PHQ-9 increase ≥ 6 points, or GAD-7 increase ≥ 4 points. The rate of deterioration was calculated at each assessment time point.
Changes of engaging in life
Measured using a self-developed scale assessing the extent to which individuals' daily engagement in life domains is affected by physical and psychological discomfort. The ELS-8, comprises 8 items across four domains (work/study, leisure, socializing, and sleep routine) rated on a five-point Likert scale (1 = not at all true, 5 = completely true). A total score of 8-40, with higher scores indicating that the individual is more engaged in life.
Changes of distress tolerance
The Distress Tolerance Scale is used to measure Distress Tolerance. Scores range from 5 to 75, with higher scores indicating higher levels of Distress Tolerance.
Changes of experiential avoidance
Experiential avoidance is measured with the Chinese version of the Brief Experiential Avoidance Questionnaire. 15 items are rated using a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.
Changes of cognitive flexibility
The Cognitive Flexibility Inventory is a self-reported questionnaire measuring cognitive flexibility level. Scores range from 5 to 100, with higher scores indicating higher levels of cognitive flexibility.
Click on the lead sponsor to view all of their trials.
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
