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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041619
Receipt No. R000047105
Scientific Title Efficacy of social cognitive skills training for schizophrenia and autism spectrum disorders
Date of disclosure of the study information 2020/09/07
Last modified on 2020/09/10

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Basic information
Public title Efficacy of social cognitive skills training for schizophrenia and autism spectrum disorders
Acronym Social cognitive training for schizophrenia and autism spectrum disorders
Scientific Title Efficacy of social cognitive skills training for schizophrenia and autism spectrum disorders
Scientific Title:Acronym Social cognitive training for schizophrenia and autism spectrum disorders
Region
Japan

Condition
Condition schizophrenia, autism spectrum disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to determine the scope of application and effectiveness of a group therapy intervention using the Social Cognitive Skills Training, Japanese version, for patients with schizophrenia and autism spectrum disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Social cognition:
Facial Emotion Recognition Task
Reading the Mind in the Eyes Test
Reading the Mind in Films Test
Mayer-Salovey-Caruso Emotion Intelligence Test
Key secondary outcomes Social functioning:
Rosenberg Self-Esteem Scale
Self-Consciousness Scale
Interpersonal Reactivity Index
Multidimensional Scale of Perceived Social Support
UCLA Loneliness Scale
Social Functioning Scale
WHOQOL26
Composite Rating of Social Outcome
Global Assessment of Functioning

Neurocognition:
MATRICS Consensus Cognitive Battery

Symptoms/Traits:
Positive and Negative Syndrome Scale
Childhood Autism Rating Scale-Second edition
Schizotypal Personality Questionnaire
Autism-spectrum Quotient

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Social Cognitive Skills Training (over 6 weeks in weekly 2 hours and 10 minutes group session)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. People diagnosed with schizophrenia, schizoaffective disorder, delusional disorder, schizotypal disorder, or autism spectrum disorders according to DSM-5, or diagnosed with schizophrenia, schizoaffective disorders, persistent delusional disorders, schizotypal disorder, or pervasive developmental disorders according to ICD10.
3. People who fully briefed on the research and gave his/her written consent with full understanding
Key exclusion criteria 1. People at high risk of violence, suicide attempts, or impulsive behavior
2. People with current substance or alcohol abuse
3. People with traumatic head injury, cerebrovascular disease, or neurodegenerative disease
Target sample size 88

Research contact person
Name of lead principal investigator
1st name Toshiya
Middle name
Last name Murai
Organization Graduate School of Medicine, Kyoto University
Division name Department of Psychiatry
Zip code 606-8507
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-3396
Email murai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Sadao
Middle name
Last name Otsuka
Organization Graduate School of Medicine, Kyoto University
Division name Department of Psychiatry
Zip code 606-8507
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4947
Homepage URL
Email scst.kyoto@gmail.com

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science, and Technology-Japan
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 Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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 京都大学医学部附属病院(京都府)、まるいクリニック(京都府)、宇治おうばく病院(京都府)

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 07 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
2020 Year 05 Month 19 Day
Date of IRB
2020 Year 05 Month 19 Day
Anticipated trial start date
2020 Year 09 Month 07 Day
Last follow-up date
2025 Year 02 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 31 Day
Last modified on
2020 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047105

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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