UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022528 |
|---|---|
| Receipt number | R000025928 |
| Scientific Title | Preliminary study of effectiveness of Mindfulness Class for improvement of the well-being and the stress |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2018/03/24 14:45:02 |
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Basic information
Public title
Preliminary study of effectiveness of Mindfulness Class for improvement of the well-being and the stress
Acronym
Preliminary study of Mindfulness Class for the well-being and the stress
Scientific Title
Preliminary study of effectiveness of Mindfulness Class for improvement of the well-being and the stress
Scientific Title:Acronym
Preliminary study of Mindfulness Class for the well-being and the stress
Region
| Japan |
Condition
Condition
Adults and mild psychiatric disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To preliminarily investigate whether Mindfulness class for the adults and the people with mild psychiatric disorders is effective or not for improvement of the subjective well-being and stress level.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the score of WHO five well being index at 0, 4, 8, 20, 32 weeks after the intervention
Key secondary outcomes
the score of SWLS, SUBI, RSES, MAAS, FFMQ, the Connor-Davidson Resilience Scale, RS, SCS, QIDS, GAD7, POMS, PSRS, SRS-18, PSS etc at 0, 4, 8, 20, 32 weeks after the intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness class
Weekly mindfulness class (2 hours per session) is provided for 8 weeks followed by monthly follow-up sessions until 6 months after completion of the intervention.
Interventions/Control_2
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
<Adults>
/No past history of psychiatric disorders or past history of psychiatric disorder at recovery state longer than 2 years.
<Mild psychiatric disorders>
/Diagnosed as panic disorder, agoraphobia, social anxiety disorder, obsessive compulsive disorder, adjustment disorder, or major depressive disorder (the period of the remission between 6 months and 2 years) based on DSM-IV.
Key exclusion criteria
<Adults>
/Difficult to follow up for 8 months after start of intervention
/Past history of mindfulness based intervention
/Other severe general medical conditions
<Mild psychiatric disorders>
/Past history of substance related disorders
/Alcohol dependence
/drug dependence
/Anti social personality disorder
/Severe suicidal ideation
/Difficult to follow up for 8 months after start of intervention
/Organic brain disorders
/Past history of mindfulness based intervention
/Other severe general medical conditions
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Sado |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-3353-1211
mitsusado@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Ninomiya |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-3353-1211
Homepage URL
akira-ninomiya@keio.jp
Sponsor or person
Institute
Keio University School of Medicine Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Daiwa Securities Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
慶應義塾大学医学部
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025928
| Research Plan | |
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| Registered date | File name |
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