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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043965
Receipt No. 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 2021/09/23

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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
Life Assessment Scale for the Mentally Ill
Global Assessment of Functioning
Key secondary outcomes Work and Social Assessment Scale
Eating Disorder Inventory-2
Beck Depression Inventory
Liebowits Social Anxiety Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
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 5-8 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 Standard treatment
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
40 years-old >
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. Duration of illness is above 3 years
5. People whose minimum Body Mass Index (BMI) was under 15
6. People whose current BMI is above 15
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 reseach
6. People whose motivation is at the Pre Contemplation assessed by the stage of change questionnaire
Target sample size 36

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
Email 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
Email n-iida@koto.kpu-m.ac.jp

Sponsor
Institute Department of Psychiatry, Graduate School of Medical Science,
Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Department of Psychiatry, Graduate School of Medical Science,
Kyoto Prefectural University of Medicine
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 Kyoto Prefectural University of Medicine, Ethics Committee
Address Kawaramachi-Hirokoji,Kamigyo-ku, Kyoto 602-8566, Japan
Tel 075-251-5337
Email 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
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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 17 Day
Date of IRB
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

Management information
Registered date
2021 Year 04 Month 19 Day
Last modified on
2021 Year 09 Month 23 Day


Link to view the page
URL(English) 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
Registered date File name


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