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

NCT07458100 | Recruiting

• 1 other identifier: E20250508
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 1

Brief 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; Eating Disorders; Obsessive-Compulsive Disorder; Post-Traumatic Stress Disorder, PTSD

Keywords

Cost-effectiveness; Mindfulness; Recovery; randomized controlled trial; stepped-care; Emotional Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (11)

• Time to relapse

  at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

• Rate of reliable improvement

  at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

• Rate of reliable recovery

  at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

• Deterioration rate

  at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

• Health related quality of life

  at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

Other Outcomes (7)

• Changes of engaging in life

  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

• Changes of distress tolerance

  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

• Changes of experiential avoidance

  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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the MIED group will receive an eight-week live, online group course, along with 49 days of self-guided iMIED practice delivered through a digital platform. After completing the program, participants will be offered three optional online group refresher sessions, scheduled 1, 3, and 6 months post-intervention. Some participants, based on the assessment of the group instructors, may be recommended for individual counseling sessions. After the intervention, the research team will provide participants with educational materials on medication management communication and encourage them to discuss long-term treatment plans with their attending psychiatrists, including the possibility of optimizing medication doses based on stable conditions . All medical decisions must be ultimately determined by the psychiatrist . At the same time, throughout the study, participants will go through all their treatments as usual.

Behavioral: Mindfulness Intervention for Emotional Distress

TAU Group

NO INTERVENTION

Participants in the treatment as usual (TAU) group will continue to receive routine clinical treatment for emotional disorders at their respective centers, including pharmacotherapy, psychoeducation, supportive interviews, and necessary psychosocial services . Medication types, doses, and adjustments are entirely determined by clinicians based on the patient's condition. To describe treatment exposure, we will collect treatment information from patients at baseline, post-intervention, and at 6, 12, 18, and 24 months follow-up. To avoid intervention contamination, the research team will not provide any mindfulness-related materials or training to the TAU group before the trial ends. Participants are also advised to avoid participating in other 8-week mindfulness courses . If participation is necessary, relevant information will be recorded and handled sensitively in the analysis.

Interventions

Mindfulness Intervention for Emotional Distress BEHAVIORAL

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.

Also known as: MIED

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Severe medical illnesses that may affect intervention participation or require recent hospitalization.
• Previous participation in a systematic 8-week mindfulness course.
• Inability to access the internet.

Sponsors & Collaborators

• Xi'an Mental Health Center: collaborator
• The Guangxi Zhuang Autonomous Region Brain Hospital: collaborator
• Peking University: lead
• WU'AN FIRST PEOPLE'S HOSPITAL: collaborator
• The Second Hospital of Anhui Medical University: collaborator
• DONG GUAN SEVENTH PEOPLE'S HOSPITAL: collaborator
• Affiliated Mental Health Center of Kunming Medical University: collaborator
• The Affiliated Brain Hospital of Guangzhou Medical University: collaborator
• Xiamen Medical College Affiliated Xian Yue Hospital: collaborator
• People's Hospital of Zhengzhou University: collaborator
• THE SIXTH AFFILIATED HOSPITAL OF GUANGDONG PHARMACEUTICAL UNIVERSITY: collaborator

Study Sites (1)

Peking University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Obsessive-Compulsive Disorder; Combat Disorders; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xinghua Liu

  School of Psychological and Cognitive Sciences,Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongyang Chen

CONTACT

+8618810673387; psychen@stu.pku.edu.cn

Elena Gomzyakova

CONTACT

+8618665380155; lenagom@stu.pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analysts (as part of the investigator team) are masked during the primary analysis phase, working with group codes (e.g., A/B) and unblinding only after completion of the main analysis to minimize bias .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Associate Professor

Model Details: This study follows a 3-step sequential stepped care model supported by a continuous AI-assisted Q\&A service available throughout the study period. Step 1 (Weeks 1-8) involves an 8-week online group Mindfulness-Informed Emotional Distress (MIED) course (2h/weekly) led by certified instructors and a 49-day self-guided digital practice via a WeChat mini-program, followed by psychiatric medication management education; Step 2 (Months 1-6 post-intervention) is a maintenance phase providing three optional group booster sessions (1-2h) at months 1, 3, and 6 to consolidate mindfulness gains; Step 3 (Months 6-8 post-intervention) offers intensified individual UP \& MIED counseling (up to eight 50-minute sessions) for participants not achieving reliable recovery, focusing on personalized strategy integration and functional rehabilitation.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 9, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)