Scrutinizing and Promoting Mindfulness Via New Technologies

NCT ID: NCT03148678

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-31

Study Completion Date

2019-03-05

Brief Summary

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The overall goal of the outlined study is to scrutinize and to promote mindfulness via new technologies using a combination of smartphone-based assessment and micro-interventions, fMRI and real-time fMRI-neurofeedback.

Detailed Description

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The overall goal of the outlined study is to scrutinize and to promote mindfulness via new technologies using a combination of smartphone-based assessment and micro-interventions, fMRI and real-time fMRI-neurofeedback. More specifically, we aim to i) evaluate whether smartphone-based micro-interventions affect mindfulness, stress, and mood, ii) evaluate whether mindfulness, its neural substrate, and related mental and physiological functions can be modified by training volitional control over brain activity by means of real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF), iii) differentiate neural activation patterns during mindfulness vs. mind wandering.

Conditions

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Mindfulness Stress Mood Working Memory

Keywords

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Emotional reactivity Cognitive flexibility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

A combination of sequential (mindfulness vs. mind wandering intervention) and parallel design (contingent vs. non-contingent RT-fMRI-NF)
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mindfulness first; Contingent RT-fMRI-NF

Participants start with the mindfulness intervention followed by the mind wandering intervention. The arm type "experimental" refers to contingent RT-fMRI-NF, during which participants are provided with contingent RT-fMRI-NF of their own brain activity.

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

Subjects are provided with smartphone-based mindfulness intervention.

Contingent RT-fMRI-NF

Intervention Type OTHER

Subjects are provided with contingent RT-fMRI-NF of their own brain activity.

Mind Wandering

Intervention Type BEHAVIORAL

Subjects are provided with smartphone-based mind wandering intervention.

Mindfulness first; Non-Contingent Neurofeedback

Participants start with the mindfulness intervention followed by the mind wandering intervention. The arm type "sham comparator" refers to non-contingent RT-fMRI-NF, during which participants are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.

Group Type SHAM_COMPARATOR

Mindfulness

Intervention Type BEHAVIORAL

Subjects are provided with smartphone-based mindfulness intervention.

Sham RT-fMRI-NF

Intervention Type OTHER

Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.

Mind Wandering

Intervention Type BEHAVIORAL

Subjects are provided with smartphone-based mind wandering intervention.

Mind wandering first; Contingent Neurofeedback

Participants start with the mind wandering intervention followed by the mindfulness intervention. The arm type "experimental" refers to contingent RT-fMRI-NF, during which participants are provided with contingent RT-fMRI-NF of their own brain activity.

Group Type EXPERIMENTAL

Mindfulness

Intervention Type BEHAVIORAL

Subjects are provided with smartphone-based mindfulness intervention.

Contingent RT-fMRI-NF

Intervention Type OTHER

Subjects are provided with contingent RT-fMRI-NF of their own brain activity.

Mind Wandering

Intervention Type BEHAVIORAL

Subjects are provided with smartphone-based mind wandering intervention.

Mind wandering first; Non-Contingent Neurofeedback

Participants start with the mind wandering intervention followed by the mindfulness intervention. The arm type "sham comparator" refers to non-contingent RT-fMRI-NF, during which participants are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.

Group Type SHAM_COMPARATOR

Mindfulness

Intervention Type BEHAVIORAL

Subjects are provided with smartphone-based mindfulness intervention.

Sham RT-fMRI-NF

Intervention Type OTHER

Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.

Mind Wandering

Intervention Type BEHAVIORAL

Subjects are provided with smartphone-based mind wandering intervention.

Interventions

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Mindfulness

Subjects are provided with smartphone-based mindfulness intervention.

Intervention Type BEHAVIORAL

Contingent RT-fMRI-NF

Subjects are provided with contingent RT-fMRI-NF of their own brain activity.

Intervention Type OTHER

Sham RT-fMRI-NF

Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.

Intervention Type OTHER

Mind Wandering

Subjects are provided with smartphone-based mind wandering intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Right-handedness
* Ability to participate in study procedures

Exclusion Criteria

* Color-Blindness
* Present or past psychological or psychiatric therapy
* Presence of cardiovascular disease
* History of major cerebral injury
* Medical MRI contraindication
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Basel

OTHER

Sponsor Role collaborator

Korea University

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jong-Hwan Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University

Locations

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Korea University

Seoul, , South Korea

Site Status

University of Basel

Basel, , Switzerland

Site Status

Countries

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South Korea Switzerland

References

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Kim HC, Lee JH. Spectral dynamic causal modeling of mindfulness, mind-wandering, and resting-state in the triple network using fMRI. Neuroreport. 2022 Mar 23;33(5):221-226. doi: 10.1097/WNR.0000000000001772.

Reference Type DERIVED
PMID: 35287148 (View on PubMed)

Other Identifiers

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GRNP_2013S1A2A2035364_1_2

Identifier Type: -

Identifier Source: org_study_id