UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039841 |
|---|---|
| Receipt number | R000045438 |
| Scientific Title | Elucidation of neuroscientific evidence of the effects of cognitive behavioral therapy for eating disorders |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2023/09/19 13:31:37 |
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Basic information
Public title
Eating Disorder Neuroimaging Initiative
Acronym
EDNI
Scientific Title
Elucidation of neuroscientific evidence of the effects of cognitive behavioral therapy for eating disorders
Scientific Title:Acronym
Elucidation of neuroscientific evidence of the effects of cognitive behavioral therapy for eating disorders
Region
| Japan |
Condition
Condition
Eating disorders
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate neuroscientific evidence of the effects of cognitive behavioral therapy for eating disorders
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EDE interview
Key secondary outcomes
Remission, treatment completion rate, psychological scale, Psychological measures, Brain MRI, Gene expression (at the end of CBT)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with eating disorders diagnosed by DSM-5
2) 18 years old or older
3) Body mass index (BMI) at screening is greater than 15 kg/m2 (or standard body weight-35%) and less than 40.0 kg / m2 (for outpatient treatment. In case of inpatient, lesser body weight is acceptable)
4) Native Japanese speakers
5) A person who understands the purpose and contents of this research and obtains written consent to participate in the research voluntarily
Key exclusion criteria
1) Those who have severe physical illness and need advanced physical treatments
2) Psychoatric disorders (schizophrenia, bipolar disorder, alcohol abuse / dependency, autism) preceding the history of eating disorders.
3) Persons with intellectual disabilities
4) High risk of suicide
5) MRI examination risk (body metal, possibility of pregnancy, claustrophobia, etc.)
6) Those who are expected to have difficulty visiting and receiving evaluations according to the research schedule
7) Those who are judged to be unsuitable for the research
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sekiguchi |
Organization
National institute of mental health, National Center of Neurology and Psychiatry
Division name
Behavioral Medicine
Zip code
187-8553
Address
4-1-1, Ogaewa-higashi, Kodaira, Tokyo
TEL
042-341-2711
asekiguchi@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sekiguchi |
Organization
National institute of mental health, National Center of Neurology and Psychiatry
Division name
Behavioral Medicine
Zip code
187-8553
Address
4-1-1, Ogaewa-higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
asekiguchi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japanese Agency for Medical Research and Development
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
Ethics Committee, National Center of Neurology and Psychiatry
Address
4-1-1, Ogaewa-higashi, Kodaira, Tokyo
Tel
042-341-2711
ml_rinri-jimu@ncnp.go.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
| 2020 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/11/1/e042685.long
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
191
Results
91 patients in the CBT intervention group, 15 in the TAU group, and 85 in the healthy group, of which 39 in the underweight healthy group have been completed for inclusion. Data collection is ongoing.
Results date posted
| 2023 | Year | 09 | Month | 19 | Day |
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 | 24 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To elucidate the cognitive neuroscience background of the effects of cognitive-behavioral therapy, we conduct brain MRI, blood sampling and psychological evaluation before and after cognitive-behavioral therapy for patients with eating disorders.
As control groups, we evaluate patients with eating disorders before and after treatment other than cognitive behavioral therapy, and evaluate healthy controls, as well.
Management information
Registered date
| 2020 | Year | 03 | Month | 17 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045438
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
