UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043076 |
|---|---|
| Receipt number | R000047229 |
| Scientific Title | A study of the reliability and validity of the Japanese version of The Somatic Symptom Disorder B Criteria Scale (SSD 12) |
| Date of disclosure of the study information | 2021/01/21 |
| Last modified on | 2025/03/27 15:39:40 |
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Basic information
Public title
A study of the reliability and validity of the Japanese version of The Somatic Symptom Disorder B Criteria Scale (SSD 12)
Acronym
A study of the reliability and validity of the Japanese version of SSD 12
Scientific Title
A study of the reliability and validity of the Japanese version of The Somatic Symptom Disorder B Criteria Scale (SSD 12)
Scientific Title:Acronym
A study of the reliability and validity of the Japanese version of SSD 12
Region
| Japan |
Condition
Condition
Somatic Symptom Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the reliability and validity of the Japanese version of the Somatic Symptom Disorder-B Criteria Scale (SSD 12).
Basic objectives2
Others
Basic objectives -Others
Consider the relationship between SSD 12 and anxiety, depression and QOL.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the Somatic Symptom Disorder B Criteria Scale (SSD 12)
Key secondary outcomes
PHQ 15, PHQ 9, GAD 7, HAI, DSM 5, CGI, Toronto Alexithymia Scale 20, New Stroop Test, SCRI, EQ 5D 5L and Other questionnaires.
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
Patients with Somatic Symptom Disorder, Patients who can obtain informed consent to participate in the study from their own documents,
Key exclusion criteria
Those who have insufficient conversation or understanding in Japanese, or who have been judged inappropriate by the doctor in charge.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Tominaga |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
6028566
Address
465 Kajiicho, Kamigyo Ward, Kyoto, 602-8566
TEL
0752515612
totomi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Tominaga |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Psychiatry
Zip code
6028566
Address
465 Kajiicho, Kamigyo Ward, Kyoto, 602-8566
TEL
0752515612
Homepage URL
totomi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kajiicho, Kamigyo Ward, Kyoto, 602-8566
Tel
0752515612
totomi@koto.kpu-m.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
京都府立医科大学附属病院精神科・心療内科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
The survey is being conducted on patient groups and general population groups.
Participant flow
Adverse events
Not recognized.
Outcome measures
SSD-12, PHQ-15, PHQ-9, GAD-7, SHAI and others.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We had reported the Somatic Symptom Disorder B criteria, Japanese version SSD 12 J. on 19th the Japanese Association for Cognitive Therapy Program and abstracts, 184, 2019.I presented my interim report at the International Conference. The Validation of the Japanese version of the Somatic Symptom Disorder-B Criteria Scale (J-SSD-12) under psychiatric outpatient settings in Japan: A progress report. 10th World Congress of Cognitive and Beghabioral Therapies, 5, June, 2023. Korea.
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047229
