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Emotional DistressMIED-RCTNCT07692269

Mindfulness Intervention for Emotional Distress: An EEG Study

A study testing MIED and PMR in people with Emotional Distress and Anxiety, run by Peking University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Emotional Distress, Anxiety, Depression
What is being tested?
MIED and PMR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
4 Jul 2026to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Peking University, School of Psychological and Cognitive Sciences

    Beijing, Beijing Municipality

    Xinghua Liu, PHD, +86 13371669818, xinghua_liu@pku.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Effects and Multimodal EEG Mechanisms of an 8-week Mindfulness Intervention for Emotional Distress: A Randomized Controlled Trial

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.

Read the 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.

Being tested
MIED, PMR
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIEDBehavioural

    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.

  • PMRBehavioural

    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.

Study groups in NCT07692269
Study groupRoleWhat they receive
PMR (Progressive Muscle Relaxation)Active comparatorA 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.
Receives: Behavioral: PMR
MIED (Mindfulness Intervention for Emotional Distress)ExperimentalA 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.
Receives: Behavioral: MIED

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)
  1. Patient Health Questionnaire(PHQ-9)

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure assessing the severity of depressive symptoms over the past two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms (worse outcome).

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

  2. Five Facet Mindfulness Questionnaire-20 (FFMQ-20)

    The Five Facet Mindfulness Questionnaire-20 (FFMQ-20) is a 20-item self-report measure assessing trait mindfulness across five facets. Total scores range from 20 to 100, with higher scores indicating greater mindfulness (better outcome).

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

  3. Distress Tolerance Scale (DTS)

    The Distress Tolerance Scale (DTS) is a 15-item self-report measure assessing an individual's perceived ability to tolerate and manage emotional distress. Total scores range from 15 to 75, with higher scores indicating greater distress tolerance (better outcome).

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

  4. Cognitive Flexibility Inventory (CFI)

    The Cognitive Flexibility Inventory (CFI) is a 20-item self-report measure assessing cognitive flexibility. Total scores range from 20 to 140, with higher scores indicating greater cognitive flexibility (better outcome).

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

  5. Excessive Emotional Behavior Scale (EEBS)

    EEBS is a self-report measure assessing the tendency to engage in excessive emotional behaviors in response to emotional distress. Higher scores indicate greater levels of excessive emotional behavior.

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

  6. Engagement with Life Scale (ELS)

    ELS is a self-report measure assessing the extent to which individuals engage in meaningful and valued life activities despite experiencing emotional distress. Higher scores indicate greater engagement with life.

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

  7. Chinese Perceived Stress Scale (CPSS)

    The Chinese Perceived Stress Scale-14 (CPSS-14) is a 14-item self-report measure assessing perceived stress during the past month. Total scores range from 0 to 56, with higher scores indicating greater perceived stress (worse outcome).

    Measured: baseline(T1,week 0),post-intervention(T2,week8)

  8. Late Positive Potential (LPP) early window (400-800 ms)

    Late Positive Potential (LPP; 400-800 ms mean amplitude) is an ERP component reflecting sustained controlled processing of emotional stimuli. Mean LPP amplitude within the 400-800 ms time window will be quantified at CPz, Cz, P3, Pz, and P4 during a 20-minute emotional picture rating task. Based on the best available evidence and theoretical rationale from previous mindfulness and emotion regulation studies, LPP was selected as a candidate mechanistic outcome.

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

  9. Frontal Alpha Asymmetry (FAA)

    Frontal Alpha Asymmetry (FAA; 8-13 Hz log-transformed alpha power difference) is a resting-state EEG measure of frontal hemispheric asymmetry, associated with affective processing, emotion regulation, and approach-withdrawal motivational tendencies. FAA will be calculated as the log-transformed alpha power difference between homologous frontal electrode pairs during a 5-minute resting-state EEG recording. The primary specification is FAAln = ln(F4) - ln(F3), using absolute alpha power at F3/F4. As an exploratory specification, FAAlnrel = ln[rel(F4)] - ln[rel(F3)] will also be examined, where rel denotes alpha power divided by total (1-45 Hz) power at the same electrode. This addition does not alter the primary specification and was made prior to any analysis of post-intervention EEG data and prior to unblinding of group allocation.

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

  10. Frontal theta power

    Frontal theta power (4-8 Hz) is a resting-state EEG measure associated with cognitive control, attentional regulation, and emotion regulation. Absolute or relative theta power within the 4-8 Hz frequency band will be quantified from frontal electrodes (e.g., Fz, F3, and F4) during a 5-minute resting-state EEG recording. Based on the best available evidence and theoretical rationale from previous mindfulness and cognitive control studies, frontal theta power was selected as a candidate mechanistic outcome.

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

  11. Fast Periodic Visual Stimulation Signal-to-Noise Ratio (FPVS-SNR)

    Fast Periodic Visual Stimulation Signal-to-Noise Ratio (FPVS-SNR) is an EEG-derived measure quantifying neural responses to periodically presented emotional visual stimuli. Change in FPVS-SNR from baseline to post-intervention will be assessed during the emotional fast periodic visual stimulation task.Based on the best available evidence and theoretical rationale, FPVS-SNR was selected as a candidate mechanistic outcome to assess changes in visual emotional processing following the intervention.

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

  12. Kessler Psychological Distress Scale (K10)

    The Kessler Psychological Distress Scale (K10) is a 10-item self-report measure assessing non-specific psychological distress during the past four weeks. Total scores range from 10 to 50, with higher scores indicating greater psychological distress (worse outcome).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start4 Jul 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07692269
Sponsor's protocol ID
E20260622
Acronym
MIED-RCT
Status last verified
Jul 2026
First submitted
25 Jun 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be made publicly available because the study involves sensitive mental health data and participant privacy must be protected. Requests for additional information regarding the study may be directed to the corresponding author.

Questions about this trial

What is this clinical trial studying?

A study testing MIED and PMR in people with Emotional Distress and Anxiety, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qinsi Zheng (+86 13457651658, qszheng25@stu.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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