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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038337
Receipt No. R000043691
Scientific Title Elucidation of action mechanisms of mindfulness group therapy
Date of disclosure of the study information 2019/10/19
Last modified on 2019/11/27

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Basic information
Public title Elucidation of action mechanisms of mindfulness group therapy
Acronym Elucidation of action mechanisms of mindfulness group therapy
Scientific Title Elucidation of action mechanisms of mindfulness group therapy
Scientific Title:Acronym Elucidation of action mechanisms of mindfulness group therapy
Region
Japan

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

Objectives
Narrative objectives1 To investigate how 8-week mindfulness group therapy affects the patients with depression and/or anxiety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in mean change scores at 8 weeks from baseline on the Beck depression inventory-2 between the groups.
Key secondary outcomes The difference in mean change scores at 8 weeks from baseline on STAI-T, FFMQ, MAIA, SCS, PTQ, MWQ, SF-36 (mental health sub-scale), FCS, EMA (SC, FC, mindfulness), EEG, meditation task, sustained attention to response test between the groups.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 8-sessions mindfulness group therapy
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
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 /diagnosed by ASD, ADHD, intellectual disability, OCD, bipolar 1 disorder, PTSD, schizophrenia(including past), alcohol dependence, drag dependence, eating disorder, BPD
/having brain disorder
/having severe physical disorder
/experience of participating in 8-sessions mindfulness program and/or long-term meditation
/dissent to the possibility of being allocated to the control group
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Kumano
Organization Waseda University
Division name Faculty of Human Science
Zip code 359-1192
Address 2-579-15, Mikajima, Tokorozawa, Saitama
TEL 04-2949-8113
Email hikumano@waseda.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Takahashi
Organization Waseda University
Division name Graduate School of Human Science
Zip code 359-1192
Address 2-579-15, Mikajima, Tokorozawa, Saitama
TEL 04-2949-8113
Homepage URL
Email totakahashi@akane.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Waseda University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Office of Research Ethics concerning Research with Human Subjects
Address 1-104, Totsuka-machi, Shinjuku-ku, Tokyo
Tel 03-5272-1639
Email rinri@list.waseda.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
2019 Year 10 Month 19 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 19 Day
Date of IRB
2018 Year 09 Month 25 Day
Anticipated trial start date
2019 Year 10 Month 19 Day
Last follow-up date
2020 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 19 Day
Last modified on
2019 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043691

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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