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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022966
Receipt No. R000026425
Scientific Title Investigation of the treatment mechanisms of mindfulness programs
Date of disclosure of the study information 2016/07/01
Last modified on 2018/11/23

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Basic information
Public title Investigation of the treatment mechanisms of mindfulness programs
Acronym Investigation of the treatment mechanisms of mindfulness programs
Scientific Title Investigation of the treatment mechanisms of mindfulness programs
Scientific Title:Acronym Investigation of the treatment mechanisms of mindfulness programs
Region
Japan

Condition
Condition depression, anxiety
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify how eight-week mindfulness program for patients of mental illness effects to their mind-wandering, depression, and anxiety.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Below outcomes at after the intervention and follow-up
Japanese Version of Beck Depression Inventory-2
Japanese Version of State-Trait Anxiety Inventory
Electroencephalogram, relates to mind-wandering
Key secondary outcomes Below outcomes at after the intervention and follow-up
Japanese Version of Five Facet Mindfulness Questionnaire
Japanese Version of Mindful Attention Awareness Scale
Japanese Version of Mind-Wandering Questionnaire
The short form of the Japanese version of the Self-Compassion Scale
Japanese Version of BIS/BAS scales

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 Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Eight-mindfulness program
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria People who complains depression or anxiety.
Key exclusion criteria People who diagnosed or suspected by M.I.N.I. as below diseases

Personality disorder, eating disorder, bipolar 1 disorder, bipolar 2 disorder (manic phase), schizophrenia, autism spectrum disorder, ADHD, obsessive-compulsive disorder, PTSD
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Kumano
Organization Waseda University
Division name Faculty of Human Science
Zip code
Address 2-579-15, Mikajima, Tokorozawa, Saitama
TEL 04-2949-8113(8321)
Email hikumano@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Issaku Kawashima
Organization Waseda University
Division name Graduate School of Human Science
Zip code
Address 2-579-15, Mikajima, Tokorozawa, Saitama
TEL 04-2949-8113(8321)
Homepage URL
Email issakuss@asagi.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Waseda University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 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
Date of protocol fixation
2016 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 01 Day
Last modified on
2018 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026425

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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