UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029426 |
|---|---|
| Receipt number | 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 11:32:05 |
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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
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
ahna0286@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033419
