UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044721 |
|---|---|
| Receipt number | R000051075 |
| Scientific Title | A randomized controlled trial examining the effect of brief mindfulness-based cognitive therapy on productivity among healthy workers |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2022/07/11 10:51:33 |
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Basic information
Public title
Does brief mindfulness-based cognitive therapy improve productivity in healthy adult workers?
-A randomized controlled trial with the waitlist control group-
Acronym
Does brief mindfulness-based cognitive therapy improve productivity in healthy adult workers?
-A randomized controlled trial with the waitlist control group-
Scientific Title
A randomized controlled trial examining the effect of brief mindfulness-based cognitive therapy on productivity among healthy workers
Scientific Title:Acronym
A randomized controlled trial examining the effect of brief mindfulness-based cognitive therapy on productivity among healthy workers
Region
| Japan |
Condition
Condition
Healthy adult workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A randomized controlled study will be conducted to determine whether brief mindfulness-based cognitive therapy can improve work productivity, work engagement, and well-being in healthy adult workers, and to what extent it is cost-effective. We will also determine what factors contribute to the effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
A comparison between the two groups of the change in absolute presenteeism as measured by the WHO-HPQ at 4, 16 and 28 weeks after the start of the study.
Key secondary outcomes
(A)Comparison of the means of FFMQ, UWES, SWLS, FS, SPANE, EQ, PSS, ICECAP-A, psychological safety scale, and meditation practice time between the two groups at the beginning of the study and at 4, 16, and 28 weeks after the start of the study.
(B)Cost-effectiveness analysis will be conducted by calculating the effect of productivity improvement obtained from WHO-HPQ and using the cost for intervention as the cost. A cost-benefit analysis will also be conducted using the QALYs calculated from ICECAP as an indicator of effectiveness.
(C) The control group will undergo the same bMBCT as the intervention group after the 28-week waiting period. bMBCT will be conducted for WHO-HPQ, FFMQ, UWES, SWLS, FS, SPANE, ES, PSS, ICECAP-A, psychological safety scale, and meditation practice time at the beginning of the study and at 4, 16, 28, 32, 44, and 56 weeks after the start of the study.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
4 weekly sessions of MBCT + 6 monthly follow-up program
Interventions/Control_2
After 7 months waiting, 4 weekly sessions of MBCT
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
-A person whose weekly working hours are 30 hours or more
-A person who has not taken a sickness leave for more than one month due to mental illness in the past, or have worked for more than six months after a sickness leave for longer than one month due to mental illness at the time of research participation.
-A person the principal investigator judge her/him fit to be included into the study regardless of her/his physical illness
-A person with an HPQ absolute presenteeism score of 8 or less
-A person who can use the Internet to answer questionnaires and participate in mindfulness classes.
-A person who can give their consent to participate in the research.
Key exclusion criteria
-A person who has an experience of mindfulness interventions for at least 8 weeks in the past
-A person who has obvious difficulties in following up during the research period
-A person whom the principal investigator judges to be unable to participate in the research due to serious physical illness
-A person whom the principal investigator judges to be unsuitable for participation in the research with other reasons.
Target sample size
220
Research contact person
Name of lead principal investigator
| 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)3-5363-3971
mitsusado@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
168-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-5363-3971
Homepage URL
mitsusado@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
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
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
| 2021 | Year | 06 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 06 | Month | 30 | Day |
Last modified on
| 2022 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051075
