UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046848 |
|---|---|
| Receipt number | R000053233 |
| Scientific Title | Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes. |
| Date of disclosure of the study information | 2022/02/07 |
| Last modified on | 2024/09/28 13:57:47 |
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Basic information
Public title
Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Acronym
Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Scientific Title
Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Scientific Title:Acronym
Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Region
| Japan |
Condition
Condition
Adults/Autism Spectrum Disorder(ASD)
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examine whether mindfulness meditation reduces mindlessness and causes changes in interpersonal attitudes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mindlessness Scale(pre-post intervention and each intervention session)
Key secondary outcomes
Demographic Data(pre intervention)
Picture Frustration Study(pre-post intervention)
The Japanese version of Five Facet Mindfulness Questionnaire(pre-post intervention and each intervention session)
Participant's impression of mindfulness meditation(each intervention session)
Answers to questions about changes in the Participant's own thoughts and feelings(each intervention session and post intervention)
Homework record
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
This study conduct lecture on mindfulness(psycho-education on mindfulness and mindfulness meditation, mindfulness meditation practice) of about one hour each for 8 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
those who are at least 20 years old at the time of Informed consent.
subjects willing and able to give informed consent.
Key exclusion criteria
having difficulty in verbal communication with the principle investigator or research member.
not able to understand psycho-education on mindfulness and the instruction of mindfulness meditation.
not able to reflect on and report changes in thoughts and feelings that occur as a result of the intervention.
not able understand and respond to the content of the measurement scales.
practice mindfulness meditation on the daily basis.
subjects may cause dissociation or flashbacks when mindfulness meditation is practiced.(e.g., Post-Traumatic Stress Disorder;Dissociative Disorder)
any condition which in the investigator's opinion, endangered the subjects if he or she participated in this trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Inoue |
Organization
Tottori University
Division name
Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code
6838503
Address
86 Nishi-cho, Yonago-shi, Tottori Japan
TEL
0859386410
masahiko-inoue@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Yuruki |
Organization
Tottori University
Division name
Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code
6838503
Address
86 Nishi-cho, Yonago-shi, Tottori Japan
TEL
0859386410
Homepage URL
M20M4010A@edu.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Tottori University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Psychology, Graduate School of Medical Sciences, Tottori University
Address
86 Nishi-cho, Yonago-shi, Tottori Japan
Tel
0859386410
M20M4010A@edu.tottori-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
| 2022 | Year | 02 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
19
Results
Undergraduate and graduate students:Total scores, Observing, Nonreactivity, and Nonjudgement on the FFMQ were significantly improved. For the Mindlessness Scale, total scores and Inhibition of Expression decreased significantly.
ASD Adult:Total scores on both the FFMQ and the Mindlessness Scale improved with intervention.
Results date posted
| 2024 | Year | 09 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The analysis of the P-F Study, one of the evaluation indicators, has been delayed. Accordingly, the release date of the results of the P-F study has not yet been determined. The results of the other evaluation indicators are scheduled to be released in October 2023.
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 04 | Day |
Baseline Characteristics
Subjects were recruited via the Internet. As a result, 17 undergraduate and graduate students participated. Three of the subjects had personal experience practicing mindfulness meditation.Three participants had developmental or mental disabilities.Two adults with a diagnosis of autism spectrum disorder also participated.
Participant flow
Seventeen participants were recruited to the study via the Internet. Two additional adults with autism spectrum disorder participated.One dropped out by the end of the intervention.
Adverse events
No adverse events occurred in this study.
Outcome measures
Five Facet MIndfulness Questionnaire(FFMQ)
Mindlessness Scale
P-F Study
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053233
