UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046727 |
|---|---|
| Receipt number | R000053296 |
| Scientific Title | A preliminary study of the impact of "Mental Fitness Botto" on mental health |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/01/26 12:07:42 |
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Basic information
Public title
A preliminary study of the impact of "Mental Fitness Botto" on mental health
Acronym
A preliminary study of the impact of "Mental Fitness Botto" on mental health
Scientific Title
A preliminary study of the impact of "Mental Fitness Botto" on mental health
Scientific Title:Acronym
A preliminary study of the impact of "Mental Fitness Botto" on mental health
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Preliminary Study of Mental Fitness Botto
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline in self-administered psychological measures of mental state, resilience, and performance in healthy participants who attended mental fitness bottow twice a week for 3 months.
The main outcome will be the WHO-5, which assesses mental health status.
Key secondary outcomes
SWLS, Four Factors of Happiness, FFMQ, MAAS, PSS,GAD7, RSES, SCS, ARS, BRS, UWES, HPQ
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Attending an online service called "Mental Fitness Botto".
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Willingness to continue with Mental Fitness Botto for 3 months.
Key exclusion criteria
People who are unable to use Botto on a continuous basis due to illness or other reasons; people involved in Botto projects and employees of companies involved in the research.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Medical and Dental University
Division name
Department of Psychiatry and Behavioral Medicine
Zip code
113-8510
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL
0358035673
hidepsyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hidehiko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Medical and Dental University
Division name
Department of Psychiatry and Behavioral Medicine
Zip code
1138510
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
TEL
0358035673
Homepage URL
hidepsyc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
NEC
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Ethics Review Committee
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo
Tel
0358035673
info.bec@tmd.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 | 03 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053296
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/01/26 | 実施計画書_第20220720版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/01/26 | S_研究対象_匿名_FIX.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/01/26 | S_受講日・受講回数_匿名.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/53296
