UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060991 |
|---|---|
| Receipt number | R000069785 |
| Scientific Title | Development and validation of the Japanese version of the Control Over Perceptual Experiences (COPE) scale |
| Date of disclosure of the study information | 2026/03/19 |
| Last modified on | 2026/03/19 13:38:43 |
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Basic information
Public title
Development and validation of a questionnaire assessing control over perceptual experiences
Acronym
a questionnaire assessing control over perceptual experiences
Scientific Title
Development and validation of the Japanese version of the Control Over Perceptual Experiences (COPE) scale
Scientific Title:Acronym
The Japanese version of the Control Over Perceptual Experiences Scale
Region
| Japan |
Condition
Condition
Mental disorders including conditions with auditory hallucinations
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the Japanese version of the Control Over Perceptual Experiences (COPE) Scale and to evaluate its psychometric properties, including reliability and validity.
Basic objectives2
Others
Basic objectives -Others
Psychometric evaluation of the reliability and validity of the Japanese version of the scale
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Reliability (internal consistency and test-retest reliability) and validity (construct validity) of the Japanese version of the COPE scale
Key secondary outcomes
Associations with other psychological measures and differences by participant characteristics
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Individuals aged 18 to 64 who have been diagnosed with a mental disorder, or those who have not received a formal diagnosis but experience mental symptoms such as auditory hallucinations, and who have experienced such hallucinations at least once a month within the past six months
-The anticipated diagnosis includes illnesses such as schizophrenia that may cause hallucinations or auditory hallucinations. The severity of the condition must be such that the individual is capable of responding to the survey
-Individuals who have consented to participate in the survey
Key exclusion criteria
-Individuals with paroxysmal disorders, cognitive impairment, or neurological disorders
-Individuals who regularly consume alcohol or non-prescription medications during the study period
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kumagaya |
Organization
The University of Tokyo
Division name
Research Center for Advanced Science and Technology
Zip code
153-8904
Address
4-6-1 Komaba, Meguro-ku, Tokyo
TEL
03-5452-5063
u-kumashin@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Katsuya |
Organization
The University of Tokyo
Division name
Research Center for Advanced Science and Technology
Zip code
153-8904
Address
4-6-1 Komaba, Meguro-ku, Tokyo
TEL
03-5452-5063
Homepage URL
https://idl.tk.rcast.u-tokyo.ac.jp/
katsuya@bfp.rcast.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Health Sciences University of Hokkaido, Bethel House, Sapporo Nakama no Mori Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学先端科学技術研究センター（東京都）、北海道医療大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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 | 02 | Month | 04 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2027 | Year | 01 | Month | 31 | Day |
Other
Other related information
To investigate the relationship between the subjective sense of control over perceptual experiences, including auditory hallucinations, and various psychological measures. Furthermore, this study aims to evaluate the internal consistency, test-retest reliability, and construct validity of the Japanese version of the COPE scale.
Management information
Registered date
| 2026 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069785
