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

Effectiveness and Cost-effectiveness of a Digital Stepped-care Mindfulness Intervention for Recovery From Emotional Disorders: a Multicentre Pragmatic Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders; Eating Disorders; Emotional Disorders; Post-Traumatic Stress Disorder, PTSD
• Intervention / Treatment: Behavioral: Mindfulness Intervention for Emotional Distress

Detailed Description

The prevalence of emotional disorders remains high, with depression and anxiety disorders being the most common (Freeman, 2022; Huang et al., 2019). Although existing treatments can alleviate symptoms in the short term, emotional disorders often follow a chronic and recurrent course, making long-term recovery difficult for patients (Mulder, 2015) and resulting in a persistent and heavy socioeconomic burden (Amos et al., 2018; GBD, 2022). Furthermore, individuals with emotional disorders often exhibit significant diagnostic instability and high comorbidity rates, making single-diagnosis interventions inadequate for real-world treatment needs (Bullis et al., 2019). Consequently, developing intervention strategies applicable to high comorbidity and capable of delivering long-term recovery benefits represents an urgent requirement in current emotional disorder treatment.

Transdiagnostic interventions are considered a key approach to meeting this need (Barlow et al., 2020). Grounded in the shared etiology and common mechanisms underlying psychopathology, these interventions enable practitioners to address diverse disorders using a single set of methods. Previous meta-analyses indicate that transdiagnostic interventions, exemplified by Mindfulness-Based Interventions (MBIs), yield moderate improvements in depressive and anxiety symptoms (Cuijpers et al., 2023). Specifically, Mindfulness-Based Stress Reduction (MBSR) has demonstrated potential as an alternative to medication in treating anxiety disorders (Hoge et al., 2023). For preventing depressive relapse in recurrent depression patients, Mindfulness-Based Cognitive Therapy (MBCT) proved as effective as maintenance antidepressant medication (Kuyken et al., 2015). The "Mindfulness Intervention for Emotional Distress" (MIED) employed in this study is a transdiagnostic psychological intervention developed based on MBSR and the "Unified Protocol for Cross-Diagnostic Treatment of Emotional Disorders" (UP). This program proposes a transdiagnostic psychopathology diamond model for emotional disorders, identifying four core pathological mechanisms hindering recovery: low distress tolerance, cognitive inflexibility, excessive emotional behavior, and abnormal engaging in life (Liu, 2024). MIED targets these four mechanisms through mindfulness practices combined with intervention strategies from UP (e.g., cognitive reappraisal, interoceptive exposure). This improvement of underlying pathological mechanisms is considered crucial for facilitating patients' transition from short-term symptom relief to robust, long-term recovery.

At the same time, the application of digital technology and group formats in psychological interventions continues to expand, providing low-threshold, scalable pathways for integrating transdiagnostic mindfulness interventions into routine healthcare systems (Schaeuffele et al., 2024). The digital MIED program has demonstrated promising effects in improving emotional distress and accelerating symptom improvement in emotional disorders across preliminary short-term studies (Ju et al., 2022; Li et al., 2024; Li et al., 2025; Wang et al., 2024). The high-frequency interaction compensates for the lack of proactive intervention tools in current clinical care. However, the efficacy of transdiagnostic interventions in promoting long-term recovery remains under-validated. Most transdiagnostic interventions, including mindfulness-based approaches, have primarily focused on single diagnostic dimensions (Barlow et al., 2017) or non-clinical samples (Lindegaard et al., 2021) , and generally lack large-sample support and long-term follow-up (Cuijpers et al., 2023; Newby et al., 2015; Schaeuffele et al., 2024) , making it difficult to reflect the long-term benefits for individuals with emotional disorders within real-world clinical pathways. Furthermore, the potential cost-effectiveness of such interventions remains under-examined (Schaeuffele et al., 2024). Against the backdrop of prolonged course and high comorbidity in emotional disorders, these evidence gaps constrain the effective integration of cross-diagnostic mindfulness interventions within routine healthcare systems.

Beyond this, the current limited understanding of the mechanisms of action also constrains improvements in treatment outcomes (Kazdin, 2007). While numerous theories have proposed hypotheses regarding these mechanisms (Baer, 2003; Brown et al., 2007; Garland et al., 2015; Liu, 2024; Shapiro et al., 2006), research on the mechanisms underlying MBIs remains lacking in systematic validation when measured against the criteria for establishing psychological intervention mechanisms proposed by Kazdin (Kazdin, 2007, 2009). No variables have been found to satisfy most mechanism validity criteria, with particularly insufficient evidence meeting experimental manipulation, temporal priority, and consistency criteria. More rigorous, high-quality research is needed to examine MBI mechanisms.

To address these evidence gaps, we plan to conduct a large-scale, multicenter, pragmatic randomized controlled trial evaluating the long-term efficacy and cost-effectiveness of a transdiagnostic digital mindfulness intervention as an adjunct to treatment as usual (TAU). This study will also incorporate an examination of MBI mechanisms of action, aiming to facilitate further optimization of intervention protocols.

• Study Type: Interventional
• Enrollment (Estimated): 464
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dongyang Chen; Phone Number: +8618810673387; Email: psychen@stu.pku.edu.cn
• Study Contact Backup: Name: Elena Gomzyakova; Phone Number: +8618665380155; Email: lenagom@stu.pku.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University
    • Contact: Dongyang Chen; Phone Number: 86-18810673387; Email: psychen@stu.pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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.; Other Names: MIED
No Intervention: TAU Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Using the EQ-5D-5L to measure, obtain health utility index and its changes over time, for estimating quality-adjusted life years (QALYs).The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) is a standardized measure of health-related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale ranging from 1 (no problems) to 5 (extreme problems), describing the respondent's health status on the day of assessment. In addition, the EQ-5D-5L includes a visual analogue scale (EQ-VAS), on which participants rate their overall health from 0 (the worst health you can imagine) to 100 (the best health you can imagine)	at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention
Cost-effectiveness	The Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P) is designed to systematically assess both the direct medical costs (e.g., outpatient visits, hospitalizations, medication expenses) and indirect productivity losses (e.g., absenteeism, reduced work efficiency) associated with psychiatric disorders in adults. It includes a combination of quantitative and qualitative items and collects data through self-report by patients to evaluate the economic burden related to mental illness. Structured with a multidimensional framework, the TIC-P covers the frequency of healthcare resource utilization, cost accounting, and the impact on social functioning, enabling a comprehensive estimation of the economic costs associated with mental health interventions. The "cost" part of cost-effectiveness is measures with TIC-P, whereas the "effectiveness" part is the 24 months 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
Cost-utility	Cost is measured with TIC-P ; utility - QALYs derived from the EQ-5D-5L conversion.	at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention
Severity of depressive symptoms	Depressive symptoms measured using PHQ-9, focusing on how depression change over time.	at baseline(T0), at week3(T1), at week5(T2), at post-intervention(T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention.
Severity of anxiety symptoms	Anxiety symptoms measured using GAD-7, focusing on how anxiety symptoms change over time.	at baseline (T0), at week 3 (T1), at week 5 (T2), at post-intervention (T3), and at 6 (T4), 12 (T5), 18 (T6), and 24 (T7) months after the intervention.
Severity of insomnia symptoms	Insomnia symptoms measured using ISI, focusing on how insomnia symptoms change over time.	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
Severity of somatic symptoms	Somatic symptoms measured using SSS-8, focusing on how somatic symptoms change over time.	at baseline (T0), at week 3 (T1), at week 5 (T2), at post-intervention (T3), and at 6 (T4), 12 (T5), 18 (T6), and 24 (T7) months after the intervention.
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.	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	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.	at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention
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.	at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	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 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.	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 discomfort intolerance	The Discomfort Intolerance Scale (DIS) assesses individuals' tolerance of uncomfortable bodily sensations. The scale consists of 5 items rated on a 6-point Likert scale ranging from 0 (not at all like me) to 5 (completely like me). The DIS comprises two dimensions: discomfort intolerance (items 1 and 2), reflecting difficulty tolerating physical discomfort, and discomfort avoidance (items 3, 4, and 5), reflecting behavioral efforts to avoid or reduce discomfort. Higher scores indicate greater intolerance of bodily discomfort and stronger avoidance tendencies	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 mindfulness traits	Short Form Philadelphia Mindfulness Scale (PHLMS) is used to measure mindfulness traits. Scoring Method including two dimensions. The Mindfulness dimension score is the sum of scores from Items 1 to 5. The Acceptance dimension score is the sum of reversed scores from Items 6 to 10.	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
Adverse Events	Adverse events are defined as any undesirable physical or psychological experience that occurs during participation, regardless of whether it is considered related to the study procedures. Participants will be instructed to report any AEs promptly. In addition, researchers will actively inquire about AEs at each assessment point. Each reported AE will be documented using a standardized adverse event reporting form, including details such as onset time, duration, severity (mild, moderate, severe), outcome, and causal attribution (related, possibly related, unrelated).	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

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: The Second Hospital of Anhui Medical University; The Affiliated Brain Hospital of Guangzhou Medical University; People's Hospital of Zhengzhou University; WU'AN FIRST PEOPLE'S HOSPITAL; Xi'an Mental Health Center; The Guangxi Zhuang Autonomous Region Brain Hospital; DONG GUAN SEVENTH PEOPLE'S HOSPITAL; Affiliated Mental Health Center of Kunming Medical University; THE SIXTH AFFILIATED HOSPITAL OF GUANGDONG PHARMACEUTICAL UNIVERSITY; Xiamen Medical College Affiliated Xian Yue Hospital
• Investigators: Principal Investigator: Xinghua Liu, School of Psychological and Cognitive Sciences,Peking University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; Recovery; Mindfulness; Cost-effectiveness; Emotional Disorders; stepped-care
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Signs and Symptoms, Digestive; Mood Disorders; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Depressive Disorder; Obsessive-Compulsive Disorder; Feeding and Eating Disorders; Combat Disorders
• Other Study ID Numbers: E20250508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Given that the data in this study involves sensitive mental health information of patients and ethical restrictions, this research plan does not share individual-level research data with the public. If there is a reasonable academic need, an application can be made through the corresponding author, and after evaluation by the research team and the ethics committee, a decision will be made on whether to provide the necessary data summary or analytical support.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No