UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058568 |
|---|---|
| Receipt number | R000066973 |
| Scientific Title | Reliability and Validity of the Japanese version of the Maladaptive Daydreaming Scale (MDS-16): Pilot Study |
| Date of disclosure of the study information | 2025/07/23 |
| Last modified on | 2025/07/23 18:31:59 |
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Basic information
Public title
Reliability and Validity of the Japanese version of the Maladaptive Daydreaming Scale (MDS-16): Pilot Study
Acronym
Pilot study of the Japanese version of MDS-16
Scientific Title
Reliability and Validity of the Japanese version of the Maladaptive Daydreaming Scale (MDS-16): Pilot Study
Scientific Title:Acronym
Pilot study of the Japanese version of MDS-16
Region
| Japan |
Condition
Condition
Not applicable (for general adults)
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the clarity, reliability, and accuracy of the Maladaptive Daydreaming Scale (MDS-16) for the target population in order to develop a final version translated from English to Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Outcome Measures:
1. Internal consistency of the Japanese version of the MDS-16 (e.g., Cronbach's alpha)
2. Construct validity through correlation with related scales (e.g., DES-II, ASRS, PHQ-9)
3. Clarity and cultural appropriateness of items after translation and adaptation
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 18 years or older.
2) After receiving a sufficient explanation of the study and fully understanding it, participants are able to give their own voluntary written consent to participate.
3) Japanese native speakers who can understand the explanation in Japanese and can give their own voluntary consent.
[Rationale for selection]
1~2) To take into consideration safety and ethics.
3) Fluent Japanese language ability is required to develop a Japanese version of the scale.
Key exclusion criteria
Those who meet any of the following criteria:
1) Those at imminent risk of suicide.
2) Those with antisocial personality disorder.
3) Those with severe mental disorders that may require hospitalization.
4) Those who have not been fully informed of the study and have not given written consent of their own free will.
5) Those who the principal investigator otherwise considers to be inappropriate as subjects.
[Rationale for setting]
1-5) Due to ethical and safety considerations.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | YOSHIYUKI |
| Middle name | |
| Last name | HIRANO |
Organization
CHIBA UNIVERSITY
Division name
Research Center for Child Mental Development
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, Japan
TEL
043-226-2975
hirano@chiba-u.jp
Public contact
Name of contact person
| 1st name | SERTAP |
| Middle name | |
| Last name | MARAL |
Organization
CHIBA UNIVERSITY
Division name
Research Center for Child Mental Development
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, Japan
TEL
043-226-2975
Homepage URL
maral@chiba-u.jp
Sponsor or person
Institute
CHIBA UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
CHIBA UNIVERSITY
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
Chiba University Graduate School of Medicine Ethics Committee
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture (Chiba University Inohana Campus)
Tel
0432227171(5077)
inohana-rinri@chiba-u.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 | 07 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066973
