UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048732 |
|---|---|
| Receipt number | R000055522 |
| Scientific Title | Guided Internet-based Cognitive Behavioral Therapy for Bulimia Nervosa: A Multi-Institutional Randomized Controlled Trial |
| Date of disclosure of the study information | 2022/08/23 |
| Last modified on | 2023/01/22 15:03:01 |
* 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
Guided Internet-based Cognitive Behavioral Therapy for Bulimia Nervosa: A Multi-Institutional Randomized Controlled Trial
Acronym
Guided ICBT for BN: MRCT
Scientific Title
Guided Internet-based Cognitive Behavioral Therapy for Bulimia Nervosa: A Multi-Institutional Randomized Controlled Trial
Scientific Title:Acronym
Guided ICBT for BN: MRCT
Region
| Japan | Europe |
Condition
Condition
Bulimia nervosa
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the efficacy and safety of Guided Internet based cognitive behavioral therapy for patients with bulimia nervosa
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the frequency of weekly objective binge-eating and vomiting episodes between the pre and post-treatment
Key secondary outcomes
Change pre and post treatment and changes at 1 month, 3 months, 6 months, 9 months, and 21 months after the end of treatment
EDE-Q: Eating Disorder Examination Questionnaire
PHQ-9: Patient Health Questionnaire-9
GAD-7: Generalized Anxiety Disorder -7
EQ-5D-5L: The 5-level EuroQol 5 dimension
BMI: Body Mass Index
BBQ: The Brunnsviken Brief Quality of life scale
PSQI: Pittsburgh Sleep Quality Index
WAI-SF: Working Alliance Inventory
CSQ: Client Satisfaction Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Guided internet 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
| 13 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Meets the DSM-5 diagnostic criteria for bulimia nervosa.
2. Patients with a BMI of 17.5 or higher.
3. Woman aged between 13 and 65 years old at the time of obtaining informed consent.
4. Written or electronic informed consent has been obtained.
5. Patients who are receiving usual treatment, and no new drug therapy or additional changes are planned during the study period.
6. Patients who owns a personal computer, tablet, smartphone, etc., or the guardian of the research subject who is not an adult owns the above devices, and the research subject himself/herself practically uses them on a daily basis.
7. Patients who have an internet communication environment and has the minimum necessary ICT skills.
8. Not received cognitive behavioral therapy in the last 2 years.
Key exclusion criteria
1. Patients who have serious mental disorders such as organic brain disorders, psychotic disorders, and drug dependence.
2. Patients who are at imminent risk of suicide.
3. Patients who repeatedly engage in anti-social behavior.
4. Patients who have a serious progressive physical disease.
5. Patients who have difficulty in exposure to feared objects due to severe stress reactions or dissociation symptoms due to acute stress disorder or post-traumatic stress disorder.
6. Patients who are judged inappropriate by the principal investigator or the research co-investigator to conduct this research safely.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Mizuno |
Organization
University of Fukui
Division name
Research Center for Child Mental Development.
Zip code
9101193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776-61-8707
mizunoy@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Sayo |
| Middle name | |
| Last name | Hamatani |
Organization
University of Fukui
Division name
Research Center for Child Mental Development
Zip code
9101193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL
0776-61-8707
Homepage URL
https://www.iterapi.se/sites/jzenit/
sayoh@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
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
Tohoku University Hospital
University of Chiba
Dokkyo Medical University Saitama Medical Center
National Center of Neurology and Psychiatry
University of Tokushima
University of Kagoshima
Linkoping University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
Tel
0776-61-8529
chiken@ml.u-fukui.ac.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
福井大学（福井県）、東北大学病院（宮城県)、千葉大学（千葉県)、獨協医科大学埼玉医療センター(埼玉県)、国立精神神経医療研究センター（東京)、徳島大学（徳島県）、鹿児島大学（鹿児島県)、Linkoping Univeristy
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055522
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
