Mindfulness-based Stress Reduction Clinical Trial
Official title:
The Neurophysiological Effect of Mindfulness-Based Stress Reduction (MBSR) Training on Emotional Regulation
Verified date | February 2020 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2021 |
Est. primary completion date | January 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | School of Occupational Therapy, College of Medicine National Taiwan University | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | psychological trait change | measured by related questionnaire | within a month | |
Primary | subjective rating in valence/ arousal of emotional pictures | measured subjects' behavior emotion response in valence and arousal toward IAPS pictures | within a month | |
Primary | EEG-derived index, Late Positive Potential (LPP) | measured subjects' neural emotion process toward IAPS pictures | within a month |
Status | Clinical Trial | Phase | |
---|---|---|---|
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