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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03148678
Enrollment
84
Registered
2017-05-11
Start date
2017-03-31
Completion date
2019-03-05
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mindfulness, Mood, Stress, Working Memory

Keywords

Emotional reactivity, Cognitive flexibility

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.

Interventions

BEHAVIORALMindfulness

Subjects are provided with smartphone-based mindfulness intervention.

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

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

BEHAVIORALMind Wandering

Subjects are provided with smartphone-based mind wandering intervention.

Sponsors

University of Basel
CollaboratorOTHER
Korea University
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective mood assessed by Multidimensional Mood State QuestionnaireDaily, 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)
Blood oxygenation level dependent (BOLD) Signal assessed by MRIOn 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 stress reactivity assessed by Visual Analog ScaleDaily, 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 ScaleDaily, 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

MeasureTime frameDescription
Working Memory assessed by N-back task testOn 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 taskOn 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 testOn 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)

Other

MeasureTime frameDescription
Respiration Signal assessed by sensorOn 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 sensor
Subjective stress reactivity assessed by Perceived Stress Scale testOn 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 Perceived Stress Scale (PSS)
Heart rate assessed by sensorOn 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 sensor
Trait mindfulness assessed by Mindful Attention Awareness ScaleOn 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 Mindful Attention Awareness Scale (MAAS)

Countries

South Korea, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026