UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057721 |
|---|---|
| Receipt number | R000065954 |
| Scientific Title | The Relationship between Fear of Negative and Positive Evaluation by Others and Social Anxiety |
| Date of disclosure of the study information | 2025/04/26 |
| Last modified on | 2025/12/17 00:16:07 |
* 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
The Relationship between Fear of Negative and Positive Evaluation by Others and Social Anxiety
Acronym
The Relationship between Fear of Negative and Positive Evaluation and Social Anxiety
Scientific Title
The Relationship between Fear of Negative and Positive Evaluation by Others and Social Anxiety
Scientific Title:Acronym
The Relationship between Fear of Negative and Positive Evaluation and Social Anxiety
Region
| Japan |
Condition
Condition
Social anxiety disorder
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will examine the reliability and validity of the Japanese versions of the Brief Fear of Negative Evaluation Scale and the Bivalent Fear of Evaluation Scale, and clarify the relationship between fear of negative and positive evaluation by others and social anxiety.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brief Fear of Negative Evaluation Scale
Key secondary outcomes
Fear of Positive Evaluation Scale
Social Phobia Inventory
Self-Focused Attention Scale
Post-Event Processing Inventory- Trait
Patient Health Questionnare-9
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 will include 400 adults (200 males and 200 females, aged 18 years or older) without psychiatric disorders, and 400 patients (200 males and 200 females, aged 18 years or older) diagnosed with social anxiety disorder (SAD). However, for the SAD group, only individuals with a score of 22 or higher on the Social Phobia Inventory-the clinical cutoff-will be included in the analysis.
Key exclusion criteria
Individuals from whom consent for the research could not be obtained
Target sample size
800
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 | 04 | Month | 26 | 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
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cross-sectional survey will be conducted through an online survey company, targeting approximately 800 individuals living in Japan, including adults from the general population and patients with social anxiety disorder. The data will be collected at a single time point.
Management information
Registered date
| 2025 | Year | 04 | Month | 25 | 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=R000065954
