UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038782
Receipt No. R000044216
Scientific Title The feasibility and effectiveness of cognitive behavioral therapy for bulimia nervosa delivered via web-camera:Clinical study : Additional study
Date of disclosure of the study information 2019/12/06
Last modified on 2019/12/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The effectiveness of cognitive behavioral therapy for bulimia nervosa delivered via web-camera:Clinical study:Additional study
Acronym The effectiveness of cognitive behavioral therapy for bulimia nervosa delivered via web-camera:Clinical study:Additional study
Scientific Title The feasibility and effectiveness of cognitive behavioral therapy for bulimia nervosa delivered via web-camera:Clinical study : Additional study
Scientific Title:Acronym The effectiveness of cognitive behavioral therapy for bulimia nervosa delivered via web-camera: Additional study
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to clarify if 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), and the QOL rating scale EQ-5D-5L (Euro-QOL) with cognitive behavioral therapy delivered via web-camera.
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 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 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
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 16

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 1-8-1, Inohana, Chuouku, Chiba, Japan
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 12 Month 06 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
2020 Year 03 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 12 Month 04 Day
Last modified on
2019 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044216

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.