UMIN-CTR Clinical Trial

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, psychological evaluation on eating behavior and emotion regulation are the primary outcome.
Key secondary outcomes	Anxiety, Mindfulness, Impulsivity, Effortful control, Attachment, Autistic trait, Depression, Sense of coherence, Value, Empathy, Resilience, Self-esteem, Coping, Set shifting, etc.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Four weeks of mindfulness based 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	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'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	2022 Year 01 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032483