Emotional Distress / Anxiety / Depression · Interventional Study

Mindfulness Intervention for Emotional Distress: An EEG Study

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered randomized controlled trial comparing an 8-week mindfulness intervention (MIED) against progressive muscle relaxation in 160 adults with subclinical emotional distress. The study is currently recruiting and has not yet reported outcomes; the registry record specifies primary endpoints (GAD-7 at baseline, weeks 2, 4, 6, 8, and 12-week follow-up) and secondary mechanistic measures (EEG indices of emotional processing), but no efficacy or safety data are available.

What was studied

Interventional, Randomized, Parallel, Single masking, Treatment purpose. Emotional Distress, Anxiety, Depression, Stress (Psychology), Psychological; age from 18 Years; to 50 Years. Intervention: MIED (Mindfulness Intervention for Emotional Distress). Compared with: PMR (Progressive Muscle Relaxation) — Active Comparator. n = 160. 1 site: China.

Key findings

Safety

This is a registry record only; no results are reported. Efficacy, safety, and mechanistic findings are not yet available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registered but ongoing trial with no results reported; it describes a planned RCT design and primary outcome measures only, without outcome data or efficacy findings.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Generalized Anxiety Disorder-7（GAD-7） (assessed at Baseline (T1, Week 0), Week 2, Week 4, Week 6, post-intervention (T2, Week 8),…)

DesignInterventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationEmotional Distress, Anxiety, Depression, Stress (Psychology), Psychological; age from 18 Years; to 50 Years

Sample size160

InterventionMIED (Mindfulness Intervention for Emotional Distress)

ComparatorPMR (Progressive Muscle Relaxation) — Active Comparator

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned sample size160

Primary outcome measureGeneralized Anxiety Disorder-7 (GAD-7)

Assessment timepointsBaseline (Week 0), Week 2, Week 4, Week 6, Week 8 (post-intervention), Week 12 (1-month follow-up)

Secondary mechanistic outcomesMultimodal EEG: resting-state frontal alpha asymmetry/theta, Fast Periodic Visual Stimulation, event-related potentials

Caveats

This is a registry record only; no results are reported. Efficacy, safety, and mechanistic findings are not yet available.
Allocation concealment, blinding status, and details of randomization procedure are not described in this registry record.
Sample size justification and power calculation are not stated.
Study is currently recruiting; completion date and timeline for results are not specified in the source text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized controlled trial with active comparator and multimodal outcome assessment.

Directness

moderate

Targets emotional distress, anxiety, depression; includes clinical scales and mechanistic EEG measures.

Consistency

insufficient

No results reported; cannot assess consistency with other evidence.

Risk of bias

insufficient

Registration record does not describe allocation concealment, blinding, or attrition strategy.

Sample adequacy

moderate

Planned enrollment 160 participants; sample size justification not stated in registry record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07692269). This is a study registration, not published results. Lead sponsor: Peking University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 160 participants (ESTIMATED). Conditions: Emotional Distress, Anxiety, Depression, Stress (Psychology), Psychological. Interventions: BEHAVIORAL: MIED; BEHAVIORAL: PMR. Primary outcome measures: Generalized Anxiety Disorder-7（GAD-7） , Baseline (T1, Week 0), Week 2, Week 4, Week 6, post-intervention (T2, Week 8), and 1-month follow-up (Week 12). 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Emotional DistressAnxietyNCT07692269Peking UniversityDepressionPMRMIED