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Mindfulness-based Stress ReductionNCT04274387

The Neurophysiological Effect of Mindfulness-Based Stress Reduction (MBSR) Training on Emotional Regulation

A study testing Mindfulness-based Stress Reduction(MBSR) in people with Mindfulness-based Stress Reduction, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Mindfulness-based Stress Reduction
What is being tested?
Mindfulness-based Stress Reduction(MBSR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTaiwan
Study dates
14 Jul 2018to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

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 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • School of Occupational Therapy, College of Medicine National Taiwan University

    Taipei

Other trials in Taiwan

About this study

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).

Read more

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

Being tested
Mindfulness-based Stress Reduction(MBSR)
Keywords
cognitive reappraisal, mindfulness, emotion regulation, emotional distress
Medical subject headings
Emotional Regulation

What participants receive

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

  • Mindfulness-based Stress Reduction(MBSR)Behavioural

    A structural program focusing on the practice about attending to the current moment with non-judgmental attitude

Study groups in NCT04274387
Study groupRoleWhat they receive
MBSR groupExperimentalparticipants who receiving 8-week MBSR between the pretest and posttest
Receives: Behavioral: Mindfulness-based Stress Reduction(MBSR)
passive control groupNo interventionparticipants who not undergoing any interventions for 8 weeks between the pretest and posttest

What is being measured

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

  1. psychological trait change

    measured by related questionnaire

    Measured: within a month

  2. subjective rating in valence/ arousal of emotional pictures

    measured subjects' behavior emotion response in valence and arousal toward IAPS pictures

    Measured: within a month

  3. EEG-derived index, Late Positive Potential (LPP)

    measured subjects' neural emotion process toward IAPS pictures

    Measured: within a month

Timeline

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

  1. First posted18 Feb 2020
  2. Study start14 Jul 2018
  3. Primary completion10 Jan 2020
  4. Study completion31 Dec 2021 (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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
one group took MBSR course the other group serve as passive control group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274387
Sponsor's protocol ID
201803115RINC
Status last verified
Feb 2020
First submitted
16 Feb 2020
Last updated
18 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-based Stress Reduction(MBSR) in people with Mindfulness-based Stress Reduction, run by National Taiwan University Hospital at 1 site in Taiwan.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. 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 Taiwan. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

psychological trait change (time frame: within a month). The study lists 3 primary outcomes in all. 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 18 Feb 2020.

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