Mindfulness Intervention for Emotional Distress: An EEG Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorPeking University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
MIED
BehavioralA 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.
PMR
BehavioralA 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: PMR (Progressive Muscle Relaxation)Active comparator 1 intervention
Group B: MIED (Mindfulness Intervention for Emotional Distress)Experimental treatment 1 intervention
Trial outcomes
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).
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 outcomes
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).
Time frame
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).
Time frame
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).
Time frame
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).
Time frame
Baseline (T1，week0) and post-intervention (T2，week8)Other outcomes
1
Meditation-Related Adverse Events Scale (MRAES-MBP)
The MRAES-MBP is a self-report measure assessing meditation-related adverse events experienced during participation in mindfulness-based programs, including their occurrence and severity.
Time frame
Week 2, Week 4, Week 6, and Week 82
Simplified adverse events questionnaire
A simplified safety monitoring questionnaire administered biweekly to the PMR group to assess somatic discomfort and emotional reactions related to muscle relaxation practice.
Time frame
Week 2, Week 4, Week 6, and Week 83
Credibility/Expectancy Questionnaire (CEQ) score
A 6-item measure of intervention credibility and improvement expectancy, administered to assess and control for non-specific expectancy effects as a covariate in primary efficacy analyses.
Time frame
After the first group session (Week 1)4
Spectral Parameterization (FOOOF/specparam)-Derived Aperiodic and Periodic Parameters
Spectral parameterization (FOOOF/specparam)-derived measures are exploratory resting-state EEG outcomes obtained by decomposing the neural power spectrum into periodic (oscillatory) and aperiodic (1/f-like) components (Donoghue et al., 2020). From 5-minute resting-state EEG recordings, the aperiodic exponent and offset will be estimated at midline electrodes Oz and Cz (2-40 Hz fit). Oscillatory alpha-peak parameters (center frequency, power, bandwidth) from the same parameterization will also be examined. Model-fit indices and peak-detection information will be used for quality control, not as intervention outcomes. Emerging evidence links aperiodic activity to arousal, affective processing, and meditation-related states; these measures are hypothesis-generating outcomes of intervention-related change. This exploratory analysis was added during a registration revision, prior to any analysis of post-intervention EEG data and prior to unblinding of group allocation.
Time frame
Baseline (T1，week 0) and post-intervention (T2，week 8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov