UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052584 |
|---|---|
| Receipt number | R000060003 |
| Scientific Title | A randomized controlled trial of enhanced efficacy of social cognition training for schizophrenia and autism spectrum disorders |
| Date of disclosure of the study information | 2023/10/24 |
| Last modified on | 2024/11/06 10:08:43 |
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Basic information
Public title
Enhancing Social Cognition training Program's Efficacy
Acronym
EnSCoPE study
Scientific Title
A randomized controlled trial of enhanced efficacy of social cognition training for schizophrenia and autism spectrum disorders
Scientific Title:Acronym
EnSCoPE study
Region
| Japan |
Condition
Condition
schizophrenia spectrum disorder, autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized controlled trial examined the enhanced efficacy of social cognition training in patients with schizophrenia and/or autism spectrum disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in social cognitive functions (facial emotion recognition tasks) 12 weeks after the introduction of the intervention
Key secondary outcomes
Baseline (0w), post-intervention (12w), 12-week follow-up (24w), 1-year follow-up (64w):
Social functioning (social outcome composite rating)
General functioning (GAF)
QOL (WHOQOL26)
Clinical symptoms (SPQ, AQ, TAS-20)
0w, 12w, 24w:
Neurocognition (MCCB)
Clinical symptoms (BE-PSD-V2.0, CARS2-HF)
Gaze behavior (eye tracking)
0w,12w:
Brain imaging (structural and functional MRI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Social cognition training plus cognitive remediation (group sessions of 1.5 hours once a week for 12 weeks)
Interventions/Control_2
Social cognition training plus illness management training (group sessions of 1.5 hours once a week for 12 weeks)
Interventions/Control_3
Illness management training plus cognitive remediation (group sessions of 1.5 hours once a week for 12 weeks)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Meet DSM-5 schizophrenia spectrum disorder and/or autism spectrum disoder criteria
2. WAIS-III estimated IQ of 65 or higher
3. Stable condiion and availability for continued participation in the study
4. Ability to communicate, read, and write in Japanese
5. Fully understand this study and provide written infromed consent
Key exclusion criteria
1. Current substance or alcohol abuse
2. Traumatic head injury, cerebrovascular disease, or neurodegenerative disease
3. At high risk of violence, suicide attempts, or impulsive behavior
Target sample size
90
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | 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=R000060003
