Scrutinizing and Promoting Mindfulness Via New Technologies

Not Applicable

Completed

• Conditions: Mindfulness; Working Memory; Stress; Mood
• Interventions: Behavioral: Mindfulness; Other: Sham RT-fMRI-NF; Other: Contingent RT-fMRI-NF; Behavioral: Mind Wandering

• Registration Number: NCT03148678
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

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 Timeline

• Study First Submitted: 2017-03-24
• Study Start: 2017-03-31
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-11
• Primary Completion: 2019-03-05
• Study Completion: 2019-03-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Mindfulness first; Contingent RT-fMRI-NF	Mindfulness	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.
Mindfulness first; Non-Contingent Neurofeedback	Mind Wandering	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.
Mind wandering first; Contingent Neurofeedback	Mindfulness	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.
Mindfulness first; Non-Contingent Neurofeedback	Mindfulness	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.
Mindfulness first; Non-Contingent Neurofeedback	Sham RT-fMRI-NF	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.
Mind wandering first; Non-Contingent Neurofeedback	Mind Wandering	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.
Mind wandering first; Non-Contingent Neurofeedback	Mindfulness	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.
Mindfulness first; Contingent RT-fMRI-NF	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.
Mindfulness first; Contingent RT-fMRI-NF	Mind Wandering	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.
Mind wandering first; Non-Contingent Neurofeedback	Sham RT-fMRI-NF	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.
Mind wandering first; Contingent Neurofeedback	Contingent RT-fMRI-NF	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.
Mind wandering first; Contingent Neurofeedback	Mind Wandering	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	Assessed via N-back task (visual single-3-back with letters as stimuli)
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)	Assessed via emotion recognition task
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)	Assessed via computer version of Wisconsin card sorting task (WCST)

Trial Locations

Locations (2)

Korea University; 🇰🇷 Seoul, Korea, Republic of

University of Basel; 🇨🇭 Basel, Switzerland