Clinical trial NCT03148678: Scrutinizing and Promoting Mindfulness Via New Technologies
Official title: Scrutinizing and Promoting Mindfulness Via New Technologies: Smartphone-based Assessment and Micro-intervention and Functional Magnetic Resonance Imaging (fMRI) (-Neurofeedback)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Stress
Mood
Working Memory
Keywords: Emotional reactivity
Cognitive flexibility
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Korea University
First posted: 2017-05-11
Enrollment: 84
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A combination of sequential (mindfulness vs. mind wandering intervention) and parallel design (contingent vs. non-contingent RT-fMRI-NF)
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood oxygenation level dependent (BOLD) Signal assessed by MRI
timeFrame: On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
measure: State mindfulness assessed by State Mindfulness Scale
timeFrame: 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)
measure: Subjective stress reactivity assessed by Visual Analog Scale
timeFrame: 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)
measure: Subjective mood assessed by Multidimensional Mood State Questionnaire
timeFrame: 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:
measure: Emotional reactivity assessed by emotion recognition task
timeFrame: On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
measure: Working Memory assessed by N-back task test
timeFrame: On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
measure: Cognitive flexibility assessed by computer version of Wisconsin card sorting Task test
timeFrame: 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:
measure: Respiration Signal assessed by sensor
timeFrame: On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
measure: Trait mindfulness assessed by Mindful Attention Awareness Scale
timeFrame: On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
measure: Heart rate assessed by sensor
timeFrame: On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
measure: Subjective stress reactivity assessed by Perceived Stress Scale test
timeFrame: On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University
city: Basel
country: Switzerland
facility: University of Basel
Study officials:
affiliation: Korea University
name: Jong-Hwan Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.