UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041619 |
|---|---|
| Receipt number | 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 | 2024/11/06 10:17:12 |
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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 [pre-intervention, post-intervention, follow-up (6 weeks after the end of intervention)]:
Facial Emotion Recognition Task
Reading the Mind in the Eyes Test
Reading the Mind in Films Test
Mayer-Salovey-Caruso Emotion Intelligence Test
Gazefinder
Key secondary outcomes
Social functioning [pre-intervention, post-intervention, follow-up (6 weeks after the end of intervention), long-term follow-up (52 weeks after the end of intervention)]:
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 [pre-intervention, post-intervention, follow-up (6 weeks after the end of intervention)]:
MATRICS Consensus Cognitive Battery
Symptoms [pre-intervention, post-intervention, follow-up (6 weeks after the end of intervention)]:
Positive and Negative Syndrome Scale
Childhood Autism Rating Scale-Second edition
Traits [pre-intervention, post-intervention, follow-up (6 weeks after the end of intervention), long-term follow-up (52 weeks after the end of intervention)]:
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
60
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
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
scst.kyoto@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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）、京都府立洛南病院（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
47
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
| 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
| 2023 | Year | 10 | Month | 19 | 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
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047105
