UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060105 |
|---|---|
| Receipt number | R000068748 |
| Scientific Title | Longitudinal Network Analysis of Social Anxiety Symptoms and the Psychometric Properties of the Japanese Version of the Severity Measure for Social Anxiety Disorder |
| Date of disclosure of the study information | 2025/12/20 |
| Last modified on | 2025/12/17 23:30:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Longitudinal Network Analysis of Social Anxiety Symptoms and the Psychometric Properties of the Japanese Version of the Severity Measure for Social Anxiety Disorder
Acronym
J-SAD-D Development and Longitudinal Network Study
Scientific Title
Longitudinal Network Analysis of Social Anxiety Symptoms and the Psychometric Properties of the Japanese Version of the Severity Measure for Social Anxiety Disorder
Scientific Title:Acronym
J-SAD-D Development and Longitudinal Network Study
Region
| Japan |
Condition
Condition
Social anxiety disorder
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to develop a Japanese version of the Severity Measure for Social Anxiety Disorder (SAD-D) and to examine its reliability and validity. In addition, this study aims to elucidate longitudinal changes in the social anxiety symptom network using the Japanese version of the SAD-D developed in this study.
Basic objectives2
Others
Basic objectives -Others
Examination of the reliability and validity of the Japanese version of the SAD-D and elucidation of longitudinal changes in the structure of social anxiety symptoms using network analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity Measure for Social Anxiety Disorder
Key secondary outcomes
Brief Fear of Negative Evaluation Scale
Fear of Positive Evaluation Scale
Social Interaction Anxiety Scale-6 items
Social Phobia Scale-6 items
Depression Anxiety Stress Scale-10 items
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
This study includes individuals aged 18 years or older who have been diagnosed with Social Anxiety Disorder (SAD).The target sample size is approximately 2,500 participants at the first assessment, 1,000 participants at the second assessment, and 400 participants at the third assessment.
Key exclusion criteria
Individuals from whom consent for the research could not be obtained
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Noda |
Organization
Musashino University
Division name
Research Institute of Cognitive Behavior Therapy
Zip code
135-8181
Address
3-3-3 Ariake, Koutouku, Tokyo, Japan
TEL
0355307624
norashouta@outlook.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Noda |
Organization
Musashino University
Division name
Research Institute of Cognitive Behavior Therapy
Zip code
135-8181
Address
3-3-3 Ariake, Koutouku, Tokyo, Japan
TEL
0355307624
Homepage URL
norashouta@outlook.jp
Sponsor or person
Institute
Musashino University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Musashino University
Address
3-3-3 Ariake, Koutouku, Tokyo, Japan
Tel
Not open to the public
Not open to the public
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 | 12 | Month | 20 | 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 | 10 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study will be conducted through an online survey company targeting individuals with Social Anxiety Disorder (SAD) residing in Japan. The study will consist of three survey waves. Approximately 2,500 participants will be included at the first wave, approximately 1,000 participants at the second wave conducted about six months after the first wave, and approximately 400 participants at the third wave conducted about six months after the second wave.
Management information
Registered date
| 2025 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068748
