UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063329 |
|---|---|
| Receipt number | R000072377 |
| Scientific Title | A Case Series of the Japanese Version of Metacognitive Training in Routine Psychiatric Day Care: A Preliminary Examination of Cognitive and Metacognitive Outcomes, Acceptability, and Feasibility |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/18 14:46:28 |
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Basic information
Public title
A Preliminary Study of the Japanese Version of Metacognitive Training in Routine Psychiatric Day Care
Acronym
Psychiatric Day Care Metacognitive Training Study
Scientific Title
A Case Series of the Japanese Version of Metacognitive Training in Routine Psychiatric Day Care: A Preliminary Examination of Cognitive and Metacognitive Outcomes, Acceptability, and Feasibility
Scientific Title:Acronym
Metacognitive Training in Psychiatric Day Care: A Case Series
Region
| Japan |
Condition
Condition
Mental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To preliminarily examine the effects of the Japanese version of Metacognitive Training (MCT-J) on cognitive biases and metacognitive coping strategies in routine psychiatric day care.
Basic objectives2
Others
Basic objectives -Others
To preliminarily examine the feasibility and acceptability of MCT-J in routine psychiatric day care.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the total score of the Cognitive Biases Questionnaire for Psychosis (CBQp) from pre- to post-intervention. The CBQp will be assessed approximately 1-2 weeks before the first MCT-J session and approximately 1-2 weeks after the eighth MCT-J session.
Key secondary outcomes
1.Change in the total score of the self-administered Metacognitive Coping Strategy Scale (MCSS) from pre- to post-intervention. The MCSS will be assessed approximately 1-2 weeks before the first MCT-J session and approximately 1-2 weeks after the eighth MCT-J session.
2.Changes in the subscale scores of the CBQp and MCSS from pre- to post-intervention.
3.Acceptability assessed using the MCT-J Participant Satisfaction Questionnaire approximately 1-2 weeks after the eighth MCT-J session.
4.Feasibility assessed by the number of attendees at each session, attendance rate, number of participants who discontinue, reasons for absence and discontinuation, and implementation-related challenges identified by the interventionist.
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
The Japanese version of Metacognitive Training (MCT-J) will be conducted as part of routine psychiatric day care. The program consists of eight sessions, each lasting approximately 60 minutes, delivered at intervals of approximately 1-2 weeks. MCT-J uses slides, exercises, and group discussions to increase awareness of cognitive biases and promote more flexible thinking.
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
Male and Female
Key inclusion criteria
1.Aged 18 years or older.
2.Expected to continue attending psychiatric day care throughout the intervention period.
3.Have not previously participated in the Japanese version of Metacognitive Training.
4.Have received an explanation of the study and provided written informed consent to participate.
Key exclusion criteria
1.Individuals whom the site investigator and interventionist judge to have difficulty understanding the study and making a voluntary decision regarding participation.
2.Individuals whom the site investigator and interventionist judge to be unable to participate safely in the Japanese version of Metacognitive Training.
3.Individuals whose treating physician judges participation in Metacognitive Training to be inappropriate as part of routine clinical care.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yoneda |
Organization
Hirosaki University
Division name
Graduate School of Health Sciences
Zip code
0368564
Address
66-1 Honcho, Hirosaki, Aomori, Japan
TEL
0172-39-3183
k.yoneda@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | kenichiro |
| Middle name | |
| Last name | Yoneda |
Organization
Hirosaki University
Division name
Graduate School of Health Sciences
Zip code
0368564
Address
66-1 Honcho, Hirosaki, Aomori, Japan
TEL
0172-39-3183
Homepage URL
k.yoneda@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Graduate School of Health Sciences, Hirosaki University
Address
66-1 Honcho, Hirosaki, Aomori, Japan
Tel
0172-39-5910
jm5910@hirosaki-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
| 2026 | Year | 10 | Month | 19 | 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
| 2026 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 18 | Day |
Last modified on
| 2026 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072377
