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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031962
Receipt No. R000036334
Scientific Title Feasibility Study of a Guided Internet Self-Help Cognitive Behavioral Therapy for Bulimia Nervosa in Japan
Date of disclosure of the study information 2018/04/01
Last modified on 2020/07/04

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Basic information
Public title Feasibility Study of a Guided Internet Self-Help Cognitive Behavioral Therapy for Bulimia Nervosa in Japan
Acronym Feasibility Study of a Guided Internet Self-Help Cognitive Behavioral Therapy for Bulimia Nervosa in Japan
Scientific Title Feasibility Study of a Guided Internet Self-Help Cognitive Behavioral Therapy for Bulimia Nervosa in Japan
Scientific Title:Acronym Feasibility Study of a Guided Internet Self-Help Cognitive Behavioral Therapy for Bulimia Nervosa in Japan
Region
Japan

Condition
Condition Bulimia nervosa, Binge-eating disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effectiveness and feasibility of Internet based cognitive behavioral therapy for patients with bulimia nervosa or binge-eating disorder
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of binge eating frequency between for 7 days pre- and post- 16 weeks-treatment
Key secondary outcomes BITE; Bulimia Investigatory Test, Edinburgh
EDE-Q; Eating Disorder Examination Questionnaire
EDI-2; Eating Disorder Inventory-2
HADS; Hospital Anxiety and Depression Scale
EQ-5D-5L; The 5-level EuroQol 5 dimension

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Internet based cognitive behavioral therapy
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
40 years-old >=
Gender Male and Female
Key inclusion criteria Patients who met the current diagnosis of bulimia nervosa or binge-eating disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
Key exclusion criteria 1. Patients with organic brain complications/disorders
2. Patients with substance use disorders
3. Patients who are highly likely to attempt suicide
4. Patients with organic brain complications/disorders
5. Patients with substance use disorders
6. Patients who are highly likely to attempt suicide
7. Patients with severe mental disorders which require hospitalization
8. Patients with severe medical illness
9. Patients who have severe social or occupational dysfunction or have severe dysfunction in school associated with psychiatric symptoms
10. Patients who have already taken CBT on obtaining informed concern
11. Patients who are judged to be ineligible as study subjects by the principal investigators or sub-investigators

Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masaomi
Middle name
Last name Iyo
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code 260-8677
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL 043-222-7171
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Michiko
Middle name
Last name Nakazato
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code 260-8677
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email nakazato@faculty.chiba-u.jp

Sponsor
Institute Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan 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 CHiba Unibersity Hospital
Address 1-8-1 Inohana, Chuo-ku, Chiba
Tel 043-222-7171
Email shiken@office.chiba-u.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
2018 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 19 Day
Date of IRB
2018 Year 02 Month 19 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 29 Day
Last modified on
2020 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036334

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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