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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034756
Receipt No. R000039635
Official scientific title of the study Investigation of the treatment mechanisms of the mindfulness program
Date of disclosure of the study information 2018/11/02
Last modified on 2018/11/15

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Basic information
Official scientific title of the study Investigation of the treatment mechanisms of the mindfulness program
Title of the study (Brief title) Investigation of the treatment mechanisms of the mindfulness program
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether a 8-week mindfulness program for the patients with depression and/or anxiety is effective or not
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, EEG, meditation task, sustained attention to response test, emotion report task 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 program
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, 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 40

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

Public contact
Name of contact person Toru Takahashi
Organization Waseda University
Division name Graduate School of Human Science
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)

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
2018 Year 11 Month 02 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 02 Day
Anticipated trial start date
2018 Year 11 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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Publication of results Unpublished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

Management information
Registered date
2018 Year 11 Month 02 Day
Last modified on
2018 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039635

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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