UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031885 |
|---|---|
| Receipt number | 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 | 2024/08/02 08:53:22 |
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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
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
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
| 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
Completed
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
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036376
