- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04274387
The Neurophysiological Effect of Mindfulness-Based Stress Reduction (MBSR) Training on Emotional Regulation
Background Emotional distress is known to render vicious effects both mentally and physiologically to human beings. Emotional regulation is therefore an important capability to dilute the poisonous effect of emotional distress. The cognitive reappraisal and mindfulness thinking are two major strategies that have been empirically tested and supported to be effective emotional regulation approaches. Oftentimes, entry-level practitioners of mindfulness get confused easily between the cognitive reappraisal and mindfulness approach to emotional regulation in that they look similar in some of their practice forms. However, they are quite different from each other in terms of their fundamental concept. Although there are already many studies contribute to the mechanisms underlying these two approaches independently, very few studies have been proposed to directly investigate the fundamental differences of the underlying neural mechanisms between the two approaches. The current proposal therefore aims to compare the underlying neural mechanisms between the cognitive reappraisal and the mindfulness approaches within the context of emotional processing.
Objectives We propose herein a 2-year research project to address the following two hypotheses: (1) we hypothesize that the differences in terms of neural activation patterns between the mindfulness and cognitive reappraisal responses toward positive or negative stimuli in the emotion regulation task (ERT) will appear only after certain amount of MBSR training and (2) we hypothesize that the 10-week Mindfulness-based Stress Reduction (MBSR) training will be accompanied by the increased resting-state functional connectivity between the salience network (involved in the process of meta-awareness) and both the dorsal attention network (i.e., attention to the outside world) and the default mode network (i.e., attention to the internal state).
Methods For the current proposal, we will use a pre-post-test plus longitudinal follow-up design research design. Based on the power analysis, we expect to recruit 45 adults (convenient sampling). We will collect neuropsychological, EEG and fMRI data from each participants at three time points with one time point before the MBSR training course (pre-test), one time point immediately after completing the MBSR training course (post-test) and one time point 8 months after completing the MBSR training course (8-month follow-up). For the neuropsychological measures, we will use the MAAS for evaluating trait mindfulness, DERS for evaluating emotional regulation and dysregulationand IRI for evaluating cognitive and emotional empathy level. For the fMRI measures, we will analyze the functional activation patterns between the cognitive reappraisal and the mindfulness process of emotion regulation. Furthermore, we will analyze the functional connectivity based on the resting-state fMRI data to investigate the change of pre- and post-MBSR training. For EEG measures, we will further analyze the different time-frequency patterns between these two types of emotional regulation.
Anticipated results We expect that the results will help unravel the functional changes of neuronal circuits associated with the transition from habitual cognitive reappraisal strategy to a mindfulness strategy, after an intensive mindfulness-based training. We hope that the overall outcomes from the current proposal will help enrich our knowledge that will enhances the translation of applying cognitive reappraisal and mindfulness based approaches in clinical psychiatry.
Keywords: cognitive reappraisal, mindfulness, emotion regulation, emotional distress
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan
- School of Occupational Therapy, College of Medicine National Taiwan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: (1) aged 20~60 years and over; (2) no a-prior experience of any form of mindfulness/meditation training (3) being able to understand and speak Taiwanese or Mandarin; (4) no participation in any drug studies during this project period.
Exclusion Criteria: (1) aged over 60 or under 20; (2) have been trained with any form of mindfulness/meditation; (3) not speaking Taiwanese or Mandarin; (4) an inability to understand the survey questions due to apparent cognitive difficulties, serious deficits in vision or hearing; and (5) medical history of psychiatric disorders and neurological diseases (measured with BSRS-30) ;(6) have metal implants placed in the body;(7) have contraindications for undergoing an MRI scan such as having a heart pacemaker or an artificial heart valve, history of having a metal sliver in the eye or an aneurysm clip in their brain, having implanted surgical clips, having claustrophobia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MBSR group
participants who receiving 8-week MBSR between the pretest and posttest
|
A structural program focusing on the practice about attending to the current moment with non-judgmental attitude
|
NO_INTERVENTION: passive control group
participants who not undergoing any interventions for 8 weeks between the pretest and posttest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychological trait change
Time Frame: within a month
|
measured by related questionnaire
|
within a month
|
subjective rating in valence/ arousal of emotional pictures
Time Frame: within a month
|
measured subjects' behavior emotion response in valence and arousal toward IAPS pictures
|
within a month
|
EEG-derived index, Late Positive Potential (LPP)
Time Frame: within a month
|
measured subjects' neural emotion process toward IAPS pictures
|
within a month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 201803115RINC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mindfulness-based Stress Reduction
-
Alberta Health servicesTom Baker Cancer CentreUnknownCancer | Mindfulness-Based Stress Reduction (MBSR)Canada
-
Aleksandra Eriksen IshamUniversity of AarhusCompletedDepression | Mindfulness-Based Stress ReductionUnited Kingdom
-
Central South UniversityCompletedPTSD | HIV | Resilience | AIDS | Mindfulness-based Stress Reduction | ChinaChina
-
Trakya UniversityCompletedMindfulness-based Cognitive TherapyTurkey
-
The University of Hong KongActive, not recruitingMindfulness-based Intervention for PreschoolersHong Kong
-
Saglik Bilimleri UniversitesiNot yet recruitingDependent Variables of the Study: Anxiety, Depression, Stress and Salivary Cortisol Levels | Independent Variables of the Study: Women's Socio-demographic Characteristics, Mindfulness-based Stress Reduction ProgramTurkey
-
VA Office of Research and DevelopmentActive, not recruitingQuality of Life | Parkinson's Disease | Mindfulness Based Stress ReductionUnited States
-
University of Maryland, BaltimoreCompleted
-
Tel-Aviv Sourasky Medical CenterOncology Specialists, S.C.CompletedInquiry Based Stress ReductionIsrael
-
University of California, San FranciscoCompletedStress | Cognitive Change | MindfulnessUnited States
Clinical Trials on Mindfulness-based Stress Reduction(MBSR)
-
Duke UniversityNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Inflammation | Stress, Psychological | SleepUnited States
-
Ottawa Hospital Research InstituteCanadian Cancer Society (CCS)CompletedCancer | Chronic Pain | Painful Neuropathy | Worries; Pain or DisabilityCanada
-
University of California, San FranciscoCompletedDementia | Frontotemporal Dementia | Frontotemporal Lobar Degeneration | Caregiver Stress Syndrome | Caregiver Burnout | Dementia Frontal | Mindfulness Based Stress ReductionUnited States
-
University of AarhusCopenhagen University Hospital, HvidovreCompletedAn Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women.Pregnancy, High RiskDenmark
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)RecruitingArthritis, RheumatoidUnited States
-
VIA University CollegeUniversity of Copenhagen; University of AarhusUnknownInflammation | Stress, Psychological | Stress, PhysiologicalDenmark
-
Azienda Socio Sanitaria Territoriale di LeccoRecruiting
-
Women's College HospitalQueen's UniversityUnknownFeasibility Randomized Control TrialCanada
-
University of MinnesotaFairview Health ServicesCompletedMyocardial Infarction | Heart Diseases | Heart Failure | Coronary Artery Bypass | Chronic Stable Angina | AngioplastyUnited States
-
Duquesne UniversityCompletedType 1 Diabetes Mellitus