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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029426
Receipt No. R000033419
Scientific Title A single-arm pilot study of videoconference cognitive-behavioral therapy for bulimia nervosa and binge eating disorder
Date of disclosure of the study information 2017/10/04
Last modified on 2019/03/19

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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
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
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

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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