Scrutinizing and Promoting Mindfulness Via New Technologies

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148678
• Other study ID #: GRNP_2013S1A2A2035364_1_2
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Mindfulness
• Mood
• Stress
• Working Memory

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)