UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036825 |
|---|---|
| Receipt number | R000041953 |
| Scientific Title | A randomized trial of the efficacy of cognitive behavioural therapy for bulimia nervosa delivered via web-camera. |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2022/05/20 11:26:37 |
* 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
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
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/
n_numata@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041953
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
