Mindfulness Intervention for Emotional Distress: An EEG Study

NCT07692269 | Recruiting

• 1 other identifier: E20260622
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial examining the efficacy and neural mechanisms of a standardized Mindfulness Intervention for Emotional Distress (MIED) in adults with subclinical emotional distress. One hundred and sixty participants will be randomly assigned to either an 8-week MIED program or an 8-week Progressive Muscle Relaxation (PMR) active control. The primary aim is to evaluate whether MIED reduces anxiety symptoms and reshapes multilevel emotional processing as measured by multimodal EEG (resting-state FAA/theta, Fast Periodic Visual Stimulation, and event-related potentials). Assessments occur at baseline (T1), post-intervention (T2), and 1-month follow-up.

Conditions

Anxiety; Depression; Emotional Distress; Stress (Psychology); Psychological

Outcome Measures

Primary Outcomes (1)

• Generalized Anxiety Disorder-7（GAD-7）

  The GAD-7 is a 7-item self-report measure of anxiety symptom severity over the past 2 weeks. Total scores range from 0 to 21. The primary analysis examines the Group × Time interaction using linear mixed-effects models across all six assessment points (Weeks 0, 2, 4, 6, 8, and 12).

  Baseline (T1, Week 0), Week 2, Week 4, Week 6, post-intervention (T2, Week 8), and 1-month follow-up (Week 12)

Secondary Outcomes (12)

• Patient Health Questionnaire（PHQ-9）

  Baseline (T1, Week 0), Week 2, Week 4, Week 6, post-intervention (T2, Week 8), and 1-month follow-up (Week 12)

• Five Facet Mindfulness Questionnaire-20 (FFMQ-20)

  Baseline (T1，week 0) and post-intervention (T2, Week 8)

• Distress Tolerance Scale (DTS)

  Baseline (T1，week 0) and post-intervention (T2，week 8)

• Cognitive Flexibility Inventory (CFI)

  Baseline (T1，week0) and post-intervention (T2，week8)

• Excessive Emotional Behavior Scale (EEBS)

  Baseline (T1，week 0) and post-intervention (T2，week8)

Other Outcomes (3)

• Meditation-Related Adverse Events Scale (MRAES-MBP)

  Week 2, Week 4, Week 6, and Week 8

• Simplified adverse events questionnaire

  Week 2, Week 4, Week 6, and Week 8

• Credibility/Expectancy Questionnaire (CEQ) score

  After the first group session (Week 1)

Study Arms (2)

PMR (Progressive Muscle Relaxation)

ACTIVE COMPARATOR

A structured 8-week Progressive Muscle Relaxation program matched to MIED in frequency, duration, and format: weekly 2.5-hour group sessions plus daily 15-minute audio home practice. Participants progress from tension-release of major muscle groups to full-body relaxation.

Behavioral: PMR

MIED (Mindfulness Intervention for Emotional Distress)

EXPERIMENTAL

A standardized 8-week transdiagnostic mindfulness program: weekly 2.5-hour group sessions plus daily 15-minute app-based home practice (iMIED). Content includes mindful breathing, body scan, mindful walking, and loving-kindness meditation.

Behavioral: MIED

Interventions

MIED BEHAVIORAL

A standardized 8-week transdiagnostic mindfulness intervention (MIED) based on the Unified Protocol and contemporary mindfulness theory. Participants attend weekly 2.5-hour group sessions and complete daily 15-minute home practice via a mobile app (iMIED). Core practices include mindful breathing, body scan, mindful walking, and loving-kindness meditation. The program emphasizes four key strategies: engagement with life, distress tolerance, cognitive flexibility, and emotion-driven behavioral regulation. All sessions follow a structured manual to ensure fidelity.

MIED (Mindfulness Intervention for Emotional Distress)

PMR BEHAVIORAL

A structured 8-week Progressive Muscle Relaxation program matched to MIED in frequency, duration, and format. Participants attend weekly 2.5-hour group sessions and complete daily 15-minute audio-guided home practice. The program progresses from systematic tension-release of major muscle groups to full-body relaxation, controlling for non-specific therapeutic factors (group support, time, expectancy). All sessions are manualized to ensure consistent delivery.

PMR (Progressive Muscle Relaxation)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-50 years Kessler Psychological Distress Scale (K10) score \> 21 No systematic mindfulness or progressive muscle relaxation practice in the past 6 months (frequency \< 1 time per week) Normal or corrected-to-normal vision Voluntary participation with signed informed consent

You may not qualify if:

• Prior diagnosis of schizophrenia, bipolar disorder, or other severe mental disorders by a psychiatrist Suicidal plan, self-injury, or need for emergency psychological crisis intervention in the past month Currently receiving systematic psychotherapy or participating in other psychological intervention programs Started psychiatric medication within the past 3 months or on an unstable medication dosage History of epilepsy, severe brain injury, or other neurological disorders that may affect EEG measurement Severe vision or hearing impairment or other conditions preventing completion of study procedures

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University, School of Psychological and Cognitive Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Xinghua Liu, Dr.

  School of Psychological and Cognitive Science,Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinsi Zheng

CONTACT

+86 13457651658; qszheng25@stu.pku.edu.cn

Xinghua Liu

CONTACT

+86 13371669818; xinghua_liu@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the behavioral interventions, participants and interventionists cannot be blinded. However, outcome assessors conducting EEG and questionnaire evaluations at T1 and T2 will be blinded to group assignment. Data analysts will work with de-identified datasets using anonymous group codes until primary analyses are locked. If an unblinding event occurs, it will be documented and reported.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 9, 2026
• Study Start: July 4, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)