UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary study of effectiveness of Mindfulness Class for improvement of the well-being and the stress
Title of the study (Brief title)	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	Mitsuhiro Sado
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81-(0)3-3353-1211
Email	mitsusado@keio.jp

Public contact
Name of contact person	Akira Ninomiya
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 05 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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