NCT04274387

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

February 16, 2020

Last Update Submit

February 17, 2020

Conditions

Keywords

cognitive reappraisal, mindfulness, emotion regulation, emotional distress

Outcome Measures

Primary Outcomes (3)

  • psychological trait change

    measured by related questionnaire

    within a month

  • subjective rating in valence/ arousal of emotional pictures

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

    within a month

  • EEG-derived index, Late Positive Potential (LPP)

    measured subjects' neural emotion process toward IAPS pictures

    within a month

Study Arms (2)

MBSR group

EXPERIMENTAL

participants who receiving 8-week MBSR between the pretest and posttest

Behavioral: Mindfulness-based Stress Reduction(MBSR)

passive control group

NO INTERVENTION

participants who not undergoing any interventions for 8 weeks between the pretest and posttest

Interventions

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

MBSR group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Occupational Therapy, College of Medicine National Taiwan University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Emotional Regulation

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: one group took MBSR course the other group serve as passive control group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 18, 2020

Study Start

July 14, 2018

Primary Completion

January 10, 2020

Study Completion

December 31, 2021

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations