UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028868 |
|---|---|
| Receipt number | R000033025 |
| Scientific Title | Effectiveness and 10-year follow-up study of integrated cognitive-behavioral group therapy for eating disorders |
| Date of disclosure of the study information | 2017/08/29 |
| Last modified on | 2019/09/02 14:16:12 |
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Basic information
Public title
Effectiveness and 10-year follow-up study of integrated cognitive-behavioral group therapy for eating disorders
Acronym
integrated cognitive-behavioral group therapy for eating disorders
Scientific Title
Effectiveness and 10-year follow-up study of integrated cognitive-behavioral group therapy for eating disorders
Scientific Title:Acronym
integrated cognitive-behavioral group therapy for eating disorders
Region
| Japan |
Condition
Condition
eating disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing the effect of cognitive behavioral therapy on eating disorders and the 10-year prognosis between treatment completion group and dropped out group, it is possible to grasp the effectiveness of treatment and the effective treatment time / object, and difficulty It can show the direction of eating disorder treatment required.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EAT26, POMS, CISS, RSES, clinical feartures, GAF
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Outpatients with eating disorder who received group cognitive behavioral therapy
Key exclusion criteria
personality disorder with self-destructive behavior
psychosis
intellectual disability
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Yuri |
| Middle name | |
| Last name | Okamoto |
Organization
Hiroshima University
Division name
Health Service Center
Zip code
739-8514
Address
Kagamiyama 1-7-1, Higashihiroshima, Hiroshima
TEL
082-424-6186
yurioka@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Okamoto |
Organization
Hiroshima University
Division name
Health Service Center
Zip code
739-8514
Address
Kagamiyama 1-7-1, Higashihiroshima, Hiroshima
TEL
082-424-6186
Homepage URL
yurioka@hiroshima-u.ac.jp
Sponsor or person
Institute
Health Service Center, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Health Service Center, Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health Service Center, Hiroshima University
Address
Kagamiyama 1-7-1, Higashihiroshima, Hiroshima
Tel
082-424-6186
yurioka@hiroshima-u.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 29 | 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 | 06 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compare clinical features, psychological scales and social adjustment with the group who completed group cognitive behavioral therapy and the dropout group.
Management information
Registered date
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033025
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
