UMIN-CTR Clinical Trial

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	Completed
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	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 05 Month 20 Day
Date trial data considered complete	2022 Year 06 Month 20 Day
Date analysis concluded	2022 Year 08 Month 20 Day

Other
Other related information

Management information
Registered date	2019 Year 05 Month 23 Day
Last modified on	2022 Year 05 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041953