UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032271 |
|---|---|
| Receipt number | R000036798 |
| Scientific Title | Effectiveness of mindfulness-based programs for improving the subjective well-being and productivity of the labors. |
| Date of disclosure of the study information | 2018/04/16 |
| Last modified on | 2020/04/17 22:02:23 |
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Basic information
Public title
Effectiveness of mindfulness-based programs for improving the subjective well-being and productivity of the labors.
Acronym
Effectiveness of mindfulness-based programs for improving the subjective well-being and productivity of the labors.
Scientific Title
Effectiveness of mindfulness-based programs for improving the subjective well-being and productivity of the labors.
Scientific Title:Acronym
Effectiveness of mindfulness-based programs for improving the subjective well-being and productivity of the labors.
Region
| Japan |
Condition
Condition
Adults(labors)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether or not mindfulness-based programs is effective for improving the subjective well-being and productivity of the labors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The difference in mean change scores at 4,8,20,32 weeks from baseline on the Satisfaction With Life Scale between the groups.
Key secondary outcomes
The difference in mean change scores at 4,8,20,32 weeks from baseline on FS, SPANE, FFMQ, the Connor Davidson Resilience Scale, K6, PSS, HPQ Short Form Japanese final, MAIA, EQ-5D-5L, 4 Factors for Happiness between the groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Eight weekly sessions based on Mindfulness-based program and two follow-up sessions
Interventions/Control_2
no interventions
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
/No past history of mental disorders or with history but have been remitted for longer than 2 years
/Able to consent in writing
Key exclusion criteria
/Difficult to follow up for 8 months after start of intervention
/Past history of mindfulness based intervention
/Severe physical conditions
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Joichiro |
| Middle name | |
| Last name | Shirahase |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-3353-1211
shirahase@keio.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Sado |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-3353-1211
Homepage URL
mitsusado@keio.jp
Sponsor or person
Institute
Keio University School of Medicine Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
private company
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
+81-(0)3-3353-1211
med-rinri-jimu@adst.keio.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
| 2018 | Year | 04 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036798
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
