Scrutinizing and Promoting Mindfulness Via New Technologies

NCT03148678 | Completed

• 1 other identifier: GRNP_2013S1A2A2035364_1_2
• Study Type: interventional
• Target: 84
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Mindfulness; Stress; Mood; Working Memory

Keywords

Emotional reactivity; Cognitive flexibility

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Emotional reactivity assessed by 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

  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

  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 Outcomes (4)

• Respiration Signal assessed by 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

  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

  On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)

Study Arms (4)

Mindfulness first; Contingent RT-fMRI-NF

EXPERIMENTAL

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; Other: Contingent RT-fMRI-NF; Behavioral: Mind Wandering

Mindfulness first; Non-Contingent Neurofeedback

SHAM COMPARATOR

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.

Behavioral: Mindfulness; Other: Sham RT-fMRI-NF; Behavioral: Mind Wandering

Mind wandering first; Contingent Neurofeedback

EXPERIMENTAL

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; Other: Contingent RT-fMRI-NF; Behavioral: Mind Wandering

Mind wandering first; Non-Contingent Neurofeedback

SHAM COMPARATOR

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.

Behavioral: Mindfulness; Other: Sham RT-fMRI-NF; Behavioral: Mind Wandering

Interventions

Mindfulness BEHAVIORAL

Subjects are provided with smartphone-based mindfulness intervention.

Mind wandering first; Contingent Neurofeedback; Mind wandering first; Non-Contingent Neurofeedback; Mindfulness first; Contingent RT-fMRI-NF; Mindfulness first; Non-Contingent Neurofeedback

Contingent RT-fMRI-NF OTHER

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

Mind wandering first; Contingent Neurofeedback; Mindfulness first; Contingent RT-fMRI-NF

Sham RT-fMRI-NF OTHER

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

Mind wandering first; Non-Contingent Neurofeedback; Mindfulness first; Non-Contingent Neurofeedback

Mind Wandering BEHAVIORAL

Subjects are provided with smartphone-based mind wandering intervention.

Mind wandering first; Contingent Neurofeedback; Mind wandering first; Non-Contingent Neurofeedback; Mindfulness first; Contingent RT-fMRI-NF; Mindfulness first; Non-Contingent Neurofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right-handedness
• Ability to participate in study procedures

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Basel: collaborator
• Korea University: collaborator

Study Sites (2)

Korea University

Seoul, South Korea

Location

University of Basel

Basel, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35287148 DERIVED

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jong-Hwan Lee, Ph.D.

  Korea University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A combination of sequential (mindfulness vs. mind wandering intervention) and parallel design (contingent vs. non-contingent RT-fMRI-NF)

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: May 11, 2017
• Study Start: March 31, 2017
• Primary Completion: March 5, 2019
• Study Completion: March 5, 2019
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); CH (1)