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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031885
Receipt No. R000036376
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.
Date of disclosure of the study information 2018/03/27
Last modified on 2021/09/27

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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://upload.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


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