UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043965 |
|---|---|
| Receipt number | R000050066 |
| Scientific Title | Efficacy of social cognition and interaction training for eating disorder |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/10/24 13:00:08 |
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Basic information
Public title
Efficacy of social cognition and interaction training for eating disorder
Acronym
Social cognition and interaction training for eating disorder
Scientific Title
Efficacy of social cognition and interaction training for eating disorder
Scientific Title:Acronym
Social cognition and interaction training for eating disorder
Region
| Japan |
Condition
Condition
Eating Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify the effectiveness of a group therapy intervention using Social Cognition and Interaction Training, Japanese version, for patients with Eating Disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Social Cognition Screening Questionnaire(Japanese version)
Global Assessment of Functioning
Facial Emotion Selection /Identification Test (FEST/FEIT)
Key secondary outcomes
Work and Social Assessment Scale
The 20-item Toronto Alexithymia Scale
Eating Disorder Inventory-2
Beck Depression Inventory
Liebowits Social Anxiety Scale
Stress Coping Inventory
Wechsler Memory Scale-Revised (WMS-R)
Trail Making Test A and B
Rey-Osterrieth Complex Figure test: ROCF
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Social Cognition and Interaction Training : SCIT
The program involved a group of under 8 members and 20 sessions of 45 minutes - 1 hour each. Sessions will be held every week. Follow-up will be held 6 months after Session 20.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. People diagnosed with Feeding and Eating Disorders according to DSM-5
2. People who fully briefed on the research and gave his/her written consent with full understanding
3. Female
4. Age: 18 or above
Key exclusion criteria
1. People with intellectual retardation
2. People with traumatic head injury, cerebrovascular disease, or neurodegenerative disease
3. People at high risk of violence, suicide attempts, or impulsive behavior
4. People with current substance or alcohol abuse
5. People at high risk of the change of treatment during the research
6. Others that the doctor judges not to be able to participate in this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Iida |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
602-8566
Address
Kawaramachi-Hirokoji,Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
n-iida@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Iida |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
602-8566
Address
Kawaramachi-Hirokoji,Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5612
Homepage URL
n-iida@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Graduate School of Medical Science,
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Mitsubishi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine, Ethics Committee
Address
Kawaramachi-Hirokoji,Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2021 | Year | 12 | 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
7
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The design was changed from an RCT to a single arm.
It is currently running.
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
| 2021 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is currently being held, and all three people participated in the first round. The second course is conducting for four people.
Management information
Registered date
| 2021 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050066
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
