UMIN-CTR Clinical Trial

Basic information
Public title	A single-arm pilot study of videoconference cognitive-behavioral therapy for bulimia nervosa and binge eating disorder
Acronym	Cognitive-Behavioral Therapy for bulimia nervosa and binge eating disorder; pilot study
Scientific Title	A single-arm pilot study of videoconference cognitive-behavioral therapy for bulimia nervosa and binge eating disorder
Scientific Title:Acronym	Cognitive-Behavioral Therapy for bulimia nervosa and binge eating disorder; pilot study
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 videoconference cognitive-behavioral therapy for bulimia nervosa or binge eating disorder
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EDE;Eating disorders Examination [Time Frame: Changes from baseline in total of objective bulimic episodes and self-induced vomiting and laxative misuse and diuretic misuse at 16-weeks ]
Key secondary outcomes	EDE-Q;Eating Disorder Examination Questionnaire BMI;Body Mass Index Bulimia Investigatory Test, Edinburgh MR;Motivational ruler EQ-5D-5L; The 5-level EQ-5D version PHQ-9; Patient Health Questionnaire-9 GAD-7; Generalized Anxiety Disorder-7 Questionnaire for Remotal medical care WAI-SF; Working Alliance Inventory-Short Form

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	Videoconference 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 diagnosis of bulimia nervosa or binge eating disorder
Key exclusion criteria	psychotic disorder active suicidal behavior organic brain disorder antisocial personality disorder other severe mental/physical condition
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Eiji Shimizu
Organization	Chiba University Hospital
Division name	Cognitive Behavioral Therapy Center
Zip code
Address	1-8-1 Inohana, Chuoku, Chiba, Japan
TEL	043-222-7171
Email	eiji@faculty.chiba-u.jp

Public contact
1st name of contact person	1st name Middle name Last name Sayo Hamatani
Organization	Chiba University
Division name	Research Center for Child Mental Development Chiva University
Zip code
Address	1-8-1 Inohana, Chuoku, Chiba, Japan
TEL	043-226-2027
Homepage URL
Email	ahna0286@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

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
Address
Tel
Email

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	2017 Year 10 Month 04 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	2017 Year 09 Month 19 Day
Date of IRB	2017 Year 10 Month 16 Day
Anticipated trial start date	2018 Year 01 Month 11 Day
Last follow-up date	2019 Year 03 Month 14 Day
Date of closure to data entry	2019 Year 03 Month 14 Day
Date trial data considered complete	2019 Year 03 Month 20 Day
Date analysis concluded	2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 10 Month 04 Day
Last modified on	2019 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033419