UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055161 |
|---|---|
| Receipt number | R000063023 |
| Scientific Title | Elucidating the Neurological, Psychological, Physiological, and Behavioral Correlations in Participants of an 8-Week Mindfulness Course |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2024/08/05 12:29:19 |
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Basic information
Public title
Neuropsychological Research for Participants of an 8-Week Mindfulness Course
Acronym
Neuropsychological research of Mindfulness
Scientific Title
Elucidating the Neurological, Psychological, Physiological, and Behavioral Correlations in Participants of an 8-Week Mindfulness Course
Scientific Title:Acronym
Longitudinal Neuropsychological research of Mindfulness
Region
| Japan |
Condition
Condition
Healthy participants or with Psychiatric disorders
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how the 8wMT affects and correlates with psychiatric symptoms and psychological measures, physiological indicators such as skin potentials, lifestyle habits such as internet use and exercise habits, and neural activity observed with fMRI in Japanese adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in psychological indicators (especially Rosenberg's Self-Esteem Scale, Cultural Estrangement Inventory) pre- and post 8wMT intervention.
Key secondary outcomes
Association between psychological tests (especially Rosenberg's Self-Esteem Scale) and changes in connectivity of large scale networks by resting-state fMRI pre- and post 8wMT intervention.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese nationals aged between 18 and 70 who are participating in an 8-week mindfulness course (MBSR or MBCT).
Key exclusion criteria
Those who are unable to understand the Japanese language as described in the scale.
Those who have participated in the same study in the past (because one individual may take the 8wMT more than once, but the same experience, such as psychological testing, will affect the results of the analysis).
Those who are unable to submit forms to be used for online psychological testing and obtaining consent.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Fujiwara |
Organization
Kyoto University Graduate School of Medicine
Division name
Faculty of Psychiatry
Zip code
6068507
Address
54, Shogoin-Kawara-cho, Sakyo-ku, Kyoto
TEL
0757514947
hirofuji@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Morio |
| Middle name | |
| Last name | Aki |
Organization
Kyoto University Graduate School of Medicine
Division name
Faculty of Psychiatry
Zip code
6068507
Address
54, Shogoin-Kawara-cho, Sakyo-ku, Kyoto
TEL
0757514947
Homepage URL
mindfulness.kyotouniv@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Psychological tests before and after the 8-week mindfulness course, and after 6 months, and MRI images will be obtained for participants who are able to obtain them, and changes and correlations will be observed.
Management information
Registered date
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063023
