UMIN-CTR Clinical Trial

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
Email	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
Email	mitsusado@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051075