Mindfulness Intervention for Emotional Distress: An EEG Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MIED, PMR.
- Who it may be relevant to
- Registry conditions: Emotional Distress, Anxiety, Depression, Stress (Psychology). Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects and Multimodal EEG Mechanisms of an 8-week Mindfulness Intervention for Emotional Distress: A Randomized Controlled Trial
Overview
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.
Detailed description
Background. Emotional distress is a subclinical mental health condition characterized by persistent anxiety, depression, stress, and emotion dysregulation. Mindfulness interventions have shown efficacy across transdiagnostic emotional disorders, yet their neurocognitive mechanisms remain incompletely understood.
Objective. This study aims to (1) verify the dynamic intervention effects of MIED on emotional distress; (2) reveal neuroplastic changes across multiple levels of emotional processing; (3) explore associations between neural changes and symptom improvement; and (4) examine whether strategy acquisition is linked to neural remodeling.
Design. This is a two-arm, parallel-group, randomized controlled trial with single (outcomes assessor) blinding. Participants (N = 160) aged 18-50 with elevated psychological distress (K10 \> 21) will be randomized (1:1; block sizes 4 and 6) to:
Experimental arm: MIED - 8 weeks of weekly 2.5-hour group sessions plus daily 15-minute app-based（IMIED） home practice.
Active comparator arm: PMR - 8 weeks of structurally matched weekly 2.5-hour group sessions plus daily 15-minute audio home practice.
Assessments. Baseline (T1), post-intervention (T2, within 2 weeks after Week 8), and 1-month follow-up (online). During the intervention, brief online tracking (GAD-7, PHQ-9) occurs at Weeks 2, 4, and 6.
Neuroimaging. Multimodal EEG includes: (a) 5-minute resting-state EEG (FAA, theta power); (b) Fast Periodic Visual Stimulation (FPVS; 6 Hz base frequency, 1.2 Hz oddball for emotional faces) to index automatic emotional processing; (c) Task-based ERP ( LPP at 400-800 ms ) during emotional picture rating to index controlled emotional processing.
Primary Mechanistic Outcome. LPP early-window (400-800 ms) mean amplitude under negative stimulus conditions.
Statistical Analysis. Primary efficacy analyses will use linear mixed-effects models (LMM) under the intention-to-treat (ITT) principle. Missing data will be handled by restricted maximum likelihood (REML) assuming MAR, with multiple imputation as a sensitivity analysis. Hierarchical multiple comparison control: primary outcome (GAD-7) at α = 0.05 (two-sided); key secondary outcome (PHQ-9) reported with nominal and corrected p-values; remaining psychological and EEG measures corrected by Benjamini-Hochberg FDR.
Interventions
- Behavioral MIED
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 re - Behavioral PMR
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.
Primary outcome measures
- Generalized Anxiety Disorder-7（GAD-7） [Time frame: Baseline (T1, Week 0), Week 2, Week 4, Week 6, post-intervention (T2, Week 8), and 1-month follow-up (Week 12)]
Secondary outcome measures (12)
- Patient Health Questionnaire（PHQ-9） [Time frame: 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) [Time frame: Baseline (T1，week 0) and post-intervention (T2, Week 8)]
- Distress Tolerance Scale (DTS) [Time frame: Baseline (T1，week 0) and post-intervention (T2，week 8)]
- Cognitive Flexibility Inventory (CFI) [Time frame: Baseline (T1，week0) and post-intervention (T2，week8)]
- Excessive Emotional Behavior Scale (EEBS) [Time frame: Baseline (T1，week 0) and post-intervention (T2，week8)]
- Engagement with Life Scale (ELS) [Time frame: Baseline (T1，week0) and post-intervention (T2，week8)]
- Chinese Perceived Stress Scale (CPSS) [Time frame: baseline（T1，week 0），post-intervention（T2，week8）]
- Late Positive Potential (LPP) early window (400-800 ms) [Time frame: Baseline (T1，week 0) and post-intervention (T2，week 8)]
- Frontal Alpha Asymmetry (FAA) [Time frame: Baseline (T1，week 0) and post-intervention (T2，week 8)]
- Frontal theta power [Time frame: Baseline (T1，week 0) and post-intervention (T2，week 8)]
- Fast Periodic Visual Stimulation Signal-to-Noise Ratio (FPVS-SNR) [Time frame: Baseline (T1，week 0) and post-intervention (T2，week 8)]
- Kessler Psychological Distress Scale (K10) [Time frame: Baseline (T1，week 0) and post-intervention (T2, Week 8)]]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University, School of Psychological and Cognitive Sciences — Beijing
Identifiers
NCT: NCT07692269 · E20260622