Scrutinizing and Promoting Mindfulness Via New Technologies

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mindfulness, Stress, Mood, Working Memory

Intervention / Treatment
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* Behavioral: Mindfulness
* Other: Contingent RT-fMRI-NF
* Other: Sham RT-fMRI-NF
* Behavioral: Mind Wandering


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A combination of sequential (mindfulness vs. mind wandering intervention) and parallel design (contingent vs. non-contingent RT-fMRI-NF)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness first; Contingent RT-fMRI-NF<br>Participants 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. | Behavioral: Mindfulness<br>* Subjects are provided with smartphone-based mindfulness intervention.<br>Other: Contingent RT-fMRI-NF<br>* Subjects are provided with contingent RT-fMRI-NF of their own brain activity.<br>Behavioral: Mind Wandering<br>* Subjects are provided with smartphone-based mind wandering intervention.<br>|
| Sham Comparator: Mindfulness first; Non-Contingent Neurofeedback<br>Participants 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. | Behavioral: Mindfulness<br>* Subjects are provided with smartphone-based mindfulness intervention.<br>Other: Sham RT-fMRI-NF<br>* Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.<br>Behavioral: Mind Wandering<br>* Subjects are provided with smartphone-based mind wandering intervention.<br>|
| Experimental: Mind wandering first; Contingent Neurofeedback<br>Participants 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. | Behavioral: Mindfulness<br>* Subjects are provided with smartphone-based mindfulness intervention.<br>Other: Contingent RT-fMRI-NF<br>* Subjects are provided with contingent RT-fMRI-NF of their own brain activity.<br>Behavioral: Mind Wandering<br>* Subjects are provided with smartphone-based mind wandering intervention.<br>|
| Sham Comparator: Mind wandering first; Non-Contingent Neurofeedback<br>Participants 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. | Behavioral: Mindfulness<br>* Subjects are provided with smartphone-based mindfulness intervention.<br>Other: Sham RT-fMRI-NF<br>* Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.<br>Behavioral: Mind Wandering<br>* Subjects are provided with smartphone-based mind wandering intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emotional reactivity, Cognitive flexibility