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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028375
Receipt No. R000032483
Scientific Title Clarification of the effects of mindfulness to the patients with eating disorders and their neurological bases
Date of disclosure of the study information 2017/07/26
Last modified on 2019/07/28

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Basic information
Public title Clarification of the effects of mindfulness to the patients with eating disorders and their neurological bases
Acronym The effects of mindfulness to eating disorders
Scientific Title Clarification of the effects of mindfulness to the patients with eating disorders and their neurological bases
Scientific Title:Acronym The effects of mindfulness to eating disorders
Region
Japan

Condition
Condition eating disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the improvements of emotion regulation functions and eating attitudes of the patients with eating disorders and the changes of brain functions and structures related with emotion regulation functions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes MRI images: fMRI using tasks of response suppression system and reward system, resting fMRI, diffusion tensor images
psychological tests: Eating Disorder Examination Questionnaire (EDE-Q6.0), Five Facett Mindfulness Questionnaire (FFMQ)
- assessments before and 3 months after intervention
Key secondary outcomes physiological tests: eye movements, skin electronical potential
psychological tests: Barratt Impulsivity Scale (BIS-11), Effortful Control (EC), Experiences in Close Relationship, Generalized Other version (ECR-Go), Autism-Spectrum Questionnaire (AQ), Emotional Questionnaire (EQ)
- assessments before, 3 months and 9 months after intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 The researchers conduct mindfulness to the patients with eating disorders and healthy controls. One group consists of 3 to 6 patients. The period of the intervention is 3 months.
Interventions/Control_2 The researchers conduct mindfulness to healthy controls. One group consists of 3 to 6 patients. The period of the intervention is 3 months.
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
16 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria diagnosed as eating disorders with the semistructured interview SCID-1 by experienced psychiatres
Key exclusion criteria intellectual disability, schizophrenia spectrum, bipolar I disorder, neurocognitive disorders, neurological diseases, diseases influencing the metabolism of central nervous system, history of severe brain injury, insufficient ability of consent, body mass index (BMI) is less than 12kg/m2, remarkably bad nutritional condition by blood test and clinical findings
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shun&#39;ichi
Middle name
Last name Noma
Organization Kyoto University
Division name Department of Psychiatry
Zip code 611-0024
Address 3-8-17, Biwadai, Uji-shi, 611-0024 Kyoto
TEL 0774-34-5144
Email noma@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Tomomi
Middle name
Last name Noda
Organization Kyoto University
Division name Department of Psychiary
Zip code 606-8507
Address 54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto-shi, 606-8507 Kyoto
TEL 075-751-3386
Homepage URL
Email tomomi.noda.smile@gmail.com

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Ministry of science and technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kyoto University
Address 54, Shogoin-Kawaharacho, Sakyo-ku, 606-8507 Kyoto
Tel 0757513386
Email noma@kuhp.kyoto-u.ac.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
2017 Year 07 Month 26 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
2017 Year 07 Month 01 Day
Date of IRB
2017 Year 10 Month 16 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 26 Day
Last modified on
2019 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032483

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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