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MindfulnessNCT03148678

Scrutinizing and Promoting Mindfulness Via New Technologies

A study testing Mindfulness, Contingent RT-fMRI-NF and Mind Wandering in people with Mindfulness and Stress, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Mindfulness, Stress, Mood
What is being tested?
Mindfulness, Contingent RT-fMRI-NF and Mind Wandering
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
2 sitesin 2 countries
Study dates
31 Mar 2017to 5 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Right-handedness
  • Ability to participate in study procedures

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

South Korea1 site

  • Korea University

    Seoul

Other trials in South Korea

Switzerland1 site

  • University of Basel

    Basel

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Mindfulness, Contingent RT-fMRI-NF, Sham RT-fMRI-NF, Mind Wandering
Keywords
Emotional reactivity, Cognitive flexibility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MindfulnessBehavioural

    Subjects are provided with smartphone-based mindfulness intervention.

  • Contingent RT-fMRI-NFOther

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

  • Sham RT-fMRI-NFOther

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

  • Mind WanderingBehavioural

    Subjects are provided with smartphone-based mind wandering intervention.

Study groups in NCT03148678
Study groupRoleWhat they receive
Mindfulness first; Contingent RT-fMRI-NFExperimentalParticipants 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.
Receives: Behavioral: Mindfulness; Other: Contingent RT-fMRI-NF; Behavioral: Mind Wandering
Mindfulness first; Non-Contingent NeurofeedbackSham comparatorParticipants 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.
Receives: Behavioral: Mindfulness; Other: Sham RT-fMRI-NF; Behavioral: Mind Wandering
Mind wandering first; Contingent NeurofeedbackExperimentalParticipants 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.
Receives: Behavioral: Mindfulness; Other: Contingent RT-fMRI-NF; Behavioral: Mind Wandering
Mind wandering first; Non-Contingent NeurofeedbackSham comparatorParticipants 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.
Receives: Behavioral: Mindfulness; Other: Sham RT-fMRI-NF; Behavioral: Mind Wandering

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging

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

  2. State mindfulness assessed by State Mindfulness Scale

    State mindfulness, assessed via State Mindfulness Scale (SMS)

    Measured: 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)

  3. Subjective stress reactivity assessed by Visual Analog Scale

    Subjective stress reactivity, assessed via Visual Analog Scale (VAS)

    Measured: 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)

  4. Subjective mood assessed by Multidimensional Mood State Questionnaire

    Subjective mood, assessed via Multidimensional Mood State Questionnaire (MDMQ)

    Measured: 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)

  1. Emotional reactivity assessed by emotion recognition task

    Assessed via emotion recognition task

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

  2. Working Memory assessed by N-back task test

    Assessed via N-back task (visual single-3-back with letters as stimuli)

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

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

    Assessed via computer version of Wisconsin card sorting task (WCST)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2017
  2. Study start31 Mar 2017
  3. Primary completion5 Mar 2019
  4. Study completion5 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Sequential
Model description
A combination of sequential (mindfulness vs. mind wandering intervention) and parallel design (contingent vs. non-contingent RT-fMRI-NF)
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03148678
Sponsor's protocol ID
GRNP_2013S1A2A2035364_1_2
Status last verified
Dec 2024
First submitted
24 Mar 2017
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35287148

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness, Contingent RT-fMRI-NF and Mind Wandering in people with Mindfulness and Stress, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03148678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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