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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036825
Receipt No. R000041953
Scientific Title A randomized trial of the efficacy of cognitive behavioural therapy for bulimia nervosa delivered via web-camera.
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/23

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Basic information
Public title A randomized trial of the efficacy of cognitive behavioural therapy for bulimia nervosa delivered via web-camera.
Acronym A randomized trial of cognitive behavioural therapy for bulimia nervosa delivered via web-camera.
Scientific Title A randomized trial of the efficacy of cognitive behavioural therapy for bulimia nervosa delivered via web-camera.
Scientific Title:Acronym A randomized trial of cognitive behavioural therapy for bulimia nervosa delivered via web-camera.
Region
Japan

Condition
Condition Bulimia Nervosa
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The group (vCBT group) who performs cognitive behavioral therapy using video conferencing system (vCBT) in addition to treatment as usual for patients with bulimia nervosa(who have major symptoms of binge eating and self-induced vomiting) has significant improvement in the total number of binge eating and vomiting (EDE), which is the primary endpoint, and the QOL rating scale EQ-5D-5L (Euro-QOL), which is the secondary endpoint, compared with the group (TAU group).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes total number of binge eating and self-induced vomiting per 28 days
Key secondary outcomes the QOL rating scale EQ-5D-5L (Euro-QOL)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 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
65 years-old >=
Gender Female
Key inclusion criteria Primary symptom is binge eating and self-induced vomiting
Key exclusion criteria psychotic disorder
active suicidality
organic brain disorder
antisocial personality disorder
mental retardation
other severe mental / physical condition
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Eiji
Middle name
Last name Shimizu
Organization Chiba University
Division name Research center for child mental development
Zip code 260-8677
Address 1-8-1, Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Noriko
Middle name
Last name Numata
Organization Chiba University
Division name Research center for child mental development
Zip code 260-8677
Address Research center for child mental development
TEL 043-226-2027
Homepage URL https://www.cocoro.chiba-u.jp/recruit/
Email n_numata@chiba-u.jp

Sponsor
Institute Chiba university
Institute
Department

Funding Source
Organization japan society for the promotion of science
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 University
Address 1-8-1, Inohana, Chuouku, Chiba, Japan
Tel 043-226-2027
Email n_numata@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
2019 Year 06 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 11 Day
Date of IRB
2019 Year 05 Month 20 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2021 Year 03 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
2019 Year 05 Month 23 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041953

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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