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UMIN-CTR Clinical Trial |
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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 |
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.
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Acronym | Effectiveness and cost-effectiveness of mindfulness-based programs for improving the subjective well-being of healthy individuals: a randomized wait-list controlled trial.
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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.
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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.
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Region |
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Condition | ||
Condition | healthy individuals | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | /Difficult to follow up for 4 months after start of intervention
/Past history of mindfulness based intervention /Severe physical conditions |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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.
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Results date posted |
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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 |
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Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |