UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness and cost-effectiveness of mindfulness-based programs for improving the subjective well-being of healthy individuals: a randomized wait-list controlled trial.
Acronym	Effectiveness and cost-effectiveness of mindfulness-based programs for improving the subjective well-being of healthy individuals: a randomized wait-list controlled trial.
Scientific Title	Effectiveness and cost-effectiveness of mindfulness-based programs for improving the subjective well-being of healthy individuals: a randomized wait-list controlled trial.
Scientific Title:Acronym	Effectiveness and cost-effectiveness of mindfulness-based programs for improving the subjective well-being of healthy individuals: a randomized wait-list controlled trial.
Region	Japan

Condition
Condition	healthy individuals
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether or not mindfulness-based programs is effective and cost-effective for improving the subjective well-being of healthy individuals by a randomized wait-list controlled trial.
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 8 weeks from baseline on the Satisfaction With Life Scale between groups.
Key secondary outcomes	(1)The difference in mean change scores at 4,8,16 weeks from baseline on FS, SPANE, RSES, FFMQ, the Connor Davidson Resilience Scale, SCS, QIDS, GAD7, PSS, HPQ Short Form Japanese final, MAIA, EQ-5D-5L between groups. With respect to cost-effective analysis, effectiveness and cost will be evaluated by QALY or other clinical scale, and the cost for intervention respectively. (2)The difference in mean change scores at 4,16 weeks from baseline on the Satisfaction With Life scale between groups.

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
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	8 weekly sessions based on Mindfulness-based program
Interventions/Control_2	no interventions (waiting-list)
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 longer than 2 years /Score of SWLS is 24 or lower /Able to consent in writing
Key exclusion criteria	/Difficult to follow up for 4 months after start of intervention /Past history of mindfulness based intervention /Severe physical conditions
Target sample size	50

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	160-8582
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	2018 Year 03 Month 27 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/32005642/
Publication of results	Partially published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8441176/
Number of participants that the trial has enrolled	50
Results	Differences between the MBCT group and the control group regarding mean change scores for SWLS scores were significant at 8 weeks. The MBCT effect was even stronger at the 2-month follow-up.
Results date posted	2021 Year 09 Month 27 Day
Results Delayed
Results Delay Reason	Due to the delay in analysis.
Date of the first journal publication of results
Baseline Characteristics	The average age was 46.8years, and 78.0% were female. All participants were employed or were students or homemakers, and the average household income was relatively high. No significant differences between the groups were observed with respect to sociodemographic status. In terms of the clinical measures, there were no significant differences, except for SPANE-P, SPANE-B and MAIA Not-Worrying.
Participant flow	Beginning in July 2018, 90 participants were screened. Fifty participants (55.6%) met the inclusion criteria and were randomly allocated to the MBCT group (n = 25) or the waiting-list control group (n = 25). Two participants in each group dropped out.
Adverse events	No serious adverse events were observed over the study period.
Outcome measures	SWLS FS SPANE RSES FFMQ CDRISC SCS QIDS GAD7 PSS WHO-HPQ MAIA EQ-5D-5L
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 16 Day
Date of IRB	2018 Year 03 Month 27 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 10 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 25 Day
Last modified on	2021 Year 09 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036376

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.