UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040916 |
|---|---|
| Receipt number | R000046227 |
| Scientific Title | Internet-based Guided Self-help Cognitive Behavioral Therapy(iGSH-CBT) for Bulimia Nervosa in Japan: a randomized controlled trial. |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2020/09/11 19:40:42 |
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Basic information
Public title
Internet-based Guided Self-help Cognitive Behavioral Therapy(iGSH-CBT) for Bulimia Nervosa in Japan: a randomized controlled trial.
Acronym
Bulimia nervosa Research of Electronic Exercise and Self-help Education
Scientific Title
Internet-based Guided Self-help Cognitive Behavioral Therapy(iGSH-CBT) for Bulimia Nervosa in Japan: a randomized controlled trial.
Scientific Title:Acronym
Bulimia nervosa Research of Electronic Exercise and Self-help Education
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 of Internet based guided self-help 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 in the frequency of weekly objective binge-eating and vomiting episodes between the baseline and post-treatment
Key secondary outcomes
Dropout rates
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
AQ; Autism-Spectrum Quotient
ASRS-V1.1; Adult ADHD Self-Report Scale-V1.1
Patient satisfaction
Motivational ruler
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Internet-based guided self-help cognitive behavioral therapy
Interventions/Control_2
Treatment as usual
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
1.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
2.BMI is >=18 and <=30 kg/m2 at baseline
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
82
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
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
043-222-7171
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
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
043-222-7171
Homepage URL
nakazato@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Psychiatry, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-222-7171
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
| 2020 | Year | 07 | Month | 20 | 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
| 2020 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 06 | 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
| 2020 | Year | 06 | Month | 27 | Day |
Last modified on
| 2020 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046227
| 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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