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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03148678
Other study ID # GRNP_2013S1A2A2035364_1_2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 31, 2017
Est. completion date September 30, 2020

Study information

Verified date March 2020
Source University Hospital, Basel, Switzerland
Contact Jong-Hwan Lee, Ph.D.
Phone +82-10-2733-3659
Email jonghwan_lee@korea.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness
Subjects are provided with smartphone-based mindfulness intervention.
Other:
Contingent RT-fMRI-NF
Subjects are provided with contingent RT-fMRI-NF of their own brain activity.
Sham RT-fMRI-NF
Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.
Behavioral:
Mind Wandering
Subjects are provided with smartphone-based mind wandering intervention.

Locations

Country Name City State
Korea, Republic of Korea University Seoul
Switzerland University of Basel Basel

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland Korea University, University of Basel

Countries where clinical trial is conducted

Korea, Republic of,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Respiration Signal assessed by sensor Assessed via sensor 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 Trait mindfulness assessed by Mindful Attention Awareness Scale Assessed via Mindful Attention Awareness Scale (MAAS) 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 Heart rate assessed by sensor Assessed via sensor 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 Subjective stress reactivity assessed by Perceived Stress Scale test Assessed via Perceived Stress Scale (PSS) On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
Primary Blood oxygenation level dependent (BOLD) Signal assessed by MRI Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
Primary State mindfulness assessed by State Mindfulness Scale State mindfulness, assessed via State Mindfulness Scale (SMS) 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)
Primary Subjective stress reactivity assessed by Visual Analog Scale Subjective stress reactivity, assessed via Visual Analog Scale (VAS) 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)
Primary Subjective mood assessed by Multidimensional Mood State Questionnaire Subjective mood, assessed via Multidimensional Mood State Questionnaire (MDMQ) 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 Emotional reactivity assessed by emotion recognition task Assessed via 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)
Secondary Working Memory assessed by N-back task test Assessed via N-back task (visual single-3-back with letters as stimuli) On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
Secondary Cognitive flexibility assessed by computer version of Wisconsin card sorting Task test Assessed via computer version of Wisconsin card sorting task (WCST) On 1 day, which is the laboratory assessment day (scheduled 1 day subsequent to the last of the 10 smartphone-based micro-intervention days)
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