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NCT Number: NCT03148678

Scrutinizing and Promoting Mindfulness Via New Technologies

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.

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Key information

Conditions

Mindfulness Mood Stress Working Memory

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Korea University, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness

Behavioral

Subjects are provided with smartphone-based mindfulness intervention.

Contingent RT-fMRI-NF

Other

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

Sham RT-fMRI-NF

Other

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

Mind Wandering

Behavioral

Subjects are provided with smartphone-based mind wandering intervention.

Primary outcomes

  1. Blood oxygenation level dependent (BOLD) Signal assessed by MRI

    Time frame: 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

  2. State mindfulness assessed by State Mindfulness Scale

    Time frame: 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)

  3. Subjective stress reactivity assessed by Visual Analog Scale

    Time frame: 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)

  4. Subjective mood assessed by Multidimensional Mood State Questionnaire

    Time frame: 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)

Secondary outcomes

  1. Emotional reactivity assessed by emotion recognition task

    Time frame: 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

  2. Working Memory assessed by N-back task test

    Time frame: 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)

  3. Cognitive flexibility assessed by computer version of Wisconsin card sorting Task test

    Time frame: 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)

Other outcomes

  1. Respiration Signal assessed by sensor

    Time frame: 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 sensor

  2. Trait mindfulness assessed by Mindful Attention Awareness Scale

    Time frame: 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 Mindful Attention Awareness Scale (MAAS)

  3. Heart rate assessed by sensor

    Time frame: 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 sensor

  4. Subjective stress reactivity assessed by Perceived Stress Scale test

    Time frame: 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 Perceived Stress Scale (PSS)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Korea University
  • University of Basel

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 11, 2017
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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