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RECRUITING Not applicable ClinicalTrials.gov

Mindfulness Intervention for Emotional Distress: An EEG Study

Sponsor: Peking University • ClinicalTrials.gov ID: NCT07692269

Registry updated: 2026-09-08
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Description

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.

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.
  • 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.

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

Conditions

Emotional Distress Anxiety Depression Stress (Psychology) Psychological

Locations

  • Peking University, School of Psychological and Cognitive Sciences — Beijing, Beijing Municipality, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record