UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028375 |
|---|---|
| Receipt number | 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 | 2022/01/20 02:21:14 |
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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, 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
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
tomomi.noda.smile@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032483
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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