Scrutinizing and Promoting Mindfulness Via New Technologies

Scrutinizing and Promoting Mindfulness Via New Technologies: Smartphone-based Assessment and Micro-intervention and Functional Magnetic Resonance Imaging (fMRI) (-Neurofeedback)

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.

Study Overview

• Status: Completed
• Conditions: Stress; Mood; Working Memory; Mindfulness
• Intervention / Treatment: Other: Sham RT-fMRI-NF; Behavioral: Mindfulness; Other: Contingent RT-fMRI-NF; Behavioral: Mind Wandering

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University
• Switzerland
  • Basel, Switzerland
    • University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindfulness; Subjects are provided with smartphone-based mindfulness intervention.; Other: Contingent RT-fMRI-NF; Subjects are provided with contingent RT-fMRI-NF of their own brain activity.; Behavioral: Mind Wandering; Subjects are provided with smartphone-based mind wandering intervention.
Sham Comparator: 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.	Other: Sham RT-fMRI-NF; Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.; Behavioral: Mindfulness; Subjects are provided with smartphone-based mindfulness intervention.; Behavioral: Mind Wandering; Subjects are provided with smartphone-based mind wandering intervention.
Experimental: 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.	Behavioral: Mindfulness; Subjects are provided with smartphone-based mindfulness intervention.; Other: Contingent RT-fMRI-NF; Subjects are provided with contingent RT-fMRI-NF of their own brain activity.; Behavioral: Mind Wandering; Subjects are provided with smartphone-based mind wandering intervention.
Sham Comparator: 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.	Other: Sham RT-fMRI-NF; Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.; Behavioral: Mindfulness; Subjects are provided with smartphone-based mindfulness intervention.; Behavioral: Mind Wandering; Subjects are provided with smartphone-based mind wandering intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood oxygenation level dependent (BOLD) Signal assessed by MRI	Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging	On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
State mindfulness assessed by State Mindfulness Scale	State mindfulness, assessed via State Mindfulness Scale (SMS)	Daily, during smartphone-based micro-interventions (duration: 10 days); on 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last smartphone-based micro-intervention days)
Subjective stress reactivity assessed by Visual Analog Scale	Subjective stress reactivity, assessed via Visual Analog Scale (VAS)	Daily, during smartphone-based micro-interventions (duration: 10 days); on 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last smartphone-based micro-intervention days)
Subjective mood assessed by Multidimensional Mood State Questionnaire	Subjective mood, assessed via Multidimensional Mood State Questionnaire (MDMQ)	Daily, during smartphone-based micro-interventions (duration: 10 days); on 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last smartphone-based micro-intervention days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional reactivity assessed by emotion recognition task	Assessed via emotion recognition task	On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
Working Memory assessed by N-back task test	Assessed via N-back task (visual single-3-back with letters as stimuli)	On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
Cognitive flexibility assessed by computer version of Wisconsin card sorting Task test	Assessed via computer version of Wisconsin card sorting task (WCST)	On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiration Signal assessed by sensor	Assessed via sensor	On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
Trait mindfulness assessed by Mindful Attention Awareness Scale	Assessed via Mindful Attention Awareness Scale (MAAS)	On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
Heart rate assessed by sensor	Assessed via sensor	On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
Subjective stress reactivity assessed by Perceived Stress Scale test	Assessed via Perceived Stress Scale (PSS)	On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Korea University; University of Basel
• Investigators: Principal Investigator: Jong-Hwan Lee, Ph.D., Korea University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Actual): March 5, 2019
• Study Completion (Actual): March 5, 2019

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive flexibility; Emotional reactivity
• Other Study ID Numbers: GRNP_2013S1A2A2035364_1_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No