UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000045367 |
|---|---|
| Receipt number | R000051275 |
| Scientific Title | The Necessity for Instructors in Mindfulness-Based Intervention: Focusing on the Acquisition of Mindfulness Skills and Improving Mental Health. |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2021/09/03 14:30:36 |
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Basic information
Public title
The Necessity for Instructors in Mindfulness-Based Intervention: Focusing on the Acquisition of Mindfulness Skills and Improving Mental Health.
Acronym
The Necessity for Instructors in Mindfulness-Based Intervention.
Scientific Title
The Necessity for Instructors in Mindfulness-Based Intervention: Focusing on the Acquisition of Mindfulness Skills and Improving Mental Health.
Scientific Title:Acronym
The Necessity for Instructors in Mindfulness-Based Intervention.
Region
| Japan |
Condition
Condition
Healthy college students
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to empirically examine the significance of verbal support in a mindfulness intervention. In particular, the roles of verbal guidance during meditation and the inquiry sessions after meditation are examined. Three groups are established: a "no verbal support group" in which verbal support by the instructor is minimized, a "inquiry group" in which only questions and answers are given after meditation, and a "verbal support group" in which both guidance during meditation and inquiries are given correctly according to the instruction manual, and their effects are compared. In addition, a qualitative study is conducted using the interview method to determine what specific teaching and instructional content promoted understanding.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological Stress Response Scale(Suzuki et al., 1997)
Pretest/Posttest/1moFU
Key secondary outcomes
Five Facet Mindfulness Questionnaire(FFMQ) (Sugiura et al.(2012)
THe "right mindfulness", "clear comprehension", and "equanimity" in mindfulness meditation scale(Tomori et al., 2020)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Mindfulness training is conducted.
Three groups are set up: a "no verbal support group" with minimal verbal support from the instructor, a "question and answer group" with only question and answer sessions after meditation, and a "verbal support group" with both guidance and question and answer sessions during meditation done correctly according to the instruction manual.
The intervention is conducted for four 90-minute sessions.
Interventions/Control_2
Mindfulness training is conducted.
Three groups are set up: a "no verbal support group" with minimal verbal support from the instructor, a "question and answer group" with only question and answer sessions after meditation, and a "verbal support group" with both guidance and question and answer sessions during meditation done correctly according to the instruction manual.
The intervention is conducted for four 90-minute sessions.
Interventions/Control_3
Mindfulness training is conducted.
Three groups are set up: a "no verbal support group" with minimal verbal support from the instructor, a "question and answer group" with only question and answer sessions after meditation, and a "verbal support group" with both guidance and question and answer sessions during meditation done correctly according to the instruction manual.
The intervention is conducted for four 90-minute sessions.
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
University students in good health (no restrictions based on age, gender, region of origin, etc.) who are able to participate in all programs.
Key exclusion criteria
Those who are currently experiencing significant psychological distress or extreme trauma immediately prior to the intervention.
Those who have a history of mental illness
Those who are currently hospitalized or taking medication for any disease.
Those who have participated in psychological experiments before.
Those who are currently ill or injured in any way.
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ito |
Organization
University of the Ryukyus
Division name
Faculty of Humanity and Social Science
Zip code
903-0213
Address
1 Senbaru, Nishihara, Okinawa, 903-0213, Japan
TEL
098-895-8423
gitoku@hs.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Tomori |
Organization
University of the Ryukyus
Division name
Faculty of Humanity and Social Science
Zip code
903-0213
Address
1Senbaru, Nishihara, Okinwa, 903-0213, Japan
TEL
098-895-8423
Homepage URL
skyhi080614@yahoo.co.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
University of the Ryukyus
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
University of the Ryukyus
Address
University of the Ryukyus
Tel
098-895-8423
gitoku@hs.u-ryukyu.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 | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 03 | Day |
Last modified on
| 2021 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051275
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