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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043076
Receipt No. 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 2021/09/19

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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 84

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
Email 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
Email totomi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email 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
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public 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
2022 Year 03 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.

Management information
Registered date
2021 Year 01 Month 21 Day
Last modified on
2021 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047229

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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