UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059660 |
|---|---|
| Receipt number | R000067980 |
| Scientific Title | Development of a Scale to Measure Characteristics of Autobiographical Editing |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/06 09:29:08 |
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Basic information
Public title
Development of a Scale to Measure Characteristics of Autobiographical Editing
Acronym
Development of a Scale to Measure Characteristics of Autobiographical Editing
Scientific Title
Development of a Scale to Measure Characteristics of Autobiographical Editing
Scientific Title:Acronym
Development of a Scale to Measure Characteristics of Autobiographical Editing
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a new scale to measure the tendency toward editing in autobiographical narratives (autobiographical editing) and to examine its psychometric properties.
Basic objectives2
Others
Basic objectives -Others
to evaluate the reliability and validity
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
An interpretable exploratory factor analysis (EFA) solution of the Autobiographical Editing Scale meeting all predefined criteria at baseline: (i) sampling adequacy with KMO >= 0.80 and significant Bartlett's test (p < 0.001); (ii) number of factors determined by parallel analysis and MAP; (iii) primary loadings >= 0.40 with cross-loadings < 0.30; (iv) item communalities >= 0.30; and (v) cumulative variance explained >= 50% for the retained factors.
Key secondary outcomes
Internal consistency: McDonalds omega > 0.80 (Cronbach s alpha also to be reported)
Testretest reliability: ICC(2,1) > 0.70 over 2~4 weeks
Convergent / discriminant validity: Preregistered directional hypotheses
Item analysis: acceptable item information and thresholds; itemtotal r > 0.30
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese individuals aged 18 to 69 years who have provided informed consent to participate in the study.
Key exclusion criteria
Individuals who do not meet the above criteria.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Takigawa |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Medical Welfare
Zip code
701-0193
Address
288 Matsushima, Kurashiki, Okayama 701-0193, Japan
TEL
086-462-1111
stakigawa@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Yokomitsu |
Organization
University of Human Environments
Division name
School of Psychological Sciences
Zip code
790-0825
Address
9-12 Dogohimata, Matsuyama, Ehime 790-8578, Japan
TEL
089-926-7007
Homepage URL
yokomitsuken5@gmail.com
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japan
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hosei University, Faculty of Science and Engineering
Address
3-7-2 Kajinocho, Koganei, Tokyo 184-8584, Japan
Tel
042-387-6033
kyamamoto@hosei.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
| 2025 | Year | 11 | 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
| 2025 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Onlive survey
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | 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=R000067980
