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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022528
Receipt No. 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

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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
Email 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
Email akira-ninomiya@keio.jp

Sponsor
Institute Keio University School of Medicine Department of Neuropsychiatry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025928

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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