UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060669 |
|---|---|
| Receipt number | R000069280 |
| Scientific Title | A Randomized Controlled trial of a Psychoeducational Web Application for Social Anxiety in Social Situations. |
| Date of disclosure of the study information | 2026/02/18 |
| Last modified on | 2026/02/13 17:23:15 |
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Basic information
Public title
Randomized Controlled Trial of a Psychoeducational Web Application for Social Anxiety in Social Situations.
Acronym
RCT of a Psychoeducational Web Application for Social Anxiety in Social Situations.
Scientific Title
A Randomized Controlled trial of a Psychoeducational Web Application for Social Anxiety in Social Situations.
Scientific Title:Acronym
RCT of a Psychoeducational Web Application for Social Anxiety in Social Situations.
Region
| Japan |
Condition
Condition
Social Anxiety.
Classification by specialty
| Psychosomatic Internal Medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the feasibility and potential effectiveness of a psychoeducational web application based on a cognitive behavioral modification approach and designed for self directed use targeted at working adults who exhibit subthreshold social anxiety tendencies characterized by fear of interpersonal interactions in social situations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change (difference) in SPIN total score from week 0 (baseline) to week 6
Key secondary outcomes
Secondary outcomes are as follows:
- Change (difference) from week 0 (baseline) in the SPIN total score at week 12 (follow-up)
- Change (difference) from pre-intervention baseline to post-intervention scores for the depression scale PHQ-9, social anxiety scale LSAS, quality of life scale EQ-5D-5L, and anxiety scale GAD-7 at weeks 6 and 12
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
web-based app education based on cognitive behavioral theory
Interventions/Control_2
No treatment(During the exam period, access the web daily and enter information such as the day's weather.)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged 18 years or older but under 65 years at the time of consent.
2) Individuals who have never previously visited a psychiatrist or psychosomatic medicine specialist and are not currently receiving treatment from one.
3) Individuals working 20 hours or more per week.
4) Individuals with a total score of 19 points or higher on the Social Phobia Inventory (SPIN).
5) Individuals who do not meet the diagnostic criteria for social anxiety disorder (based on the American Psychiatric Association's DSM-5-TR).
6) Individuals who, prior to participating in this trial, received explanations via web-based documents and video, and provided informed consent online of their own free will after achieving sufficient understanding.
7) Individuals with internet access and a computer environment capable of using web-based applications.
Key exclusion criteria
1) Individuals for whom contact with researchers is difficult.
2) Other individuals deemed unsuitable by the principal investigator or research collaborators for the safe conduct of this study.
3) Individuals at risk of suicide (those scoring 2 to 3 points on item 9 of the PHQ-9 depression scale, which assesses suicidal ideation).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1,Inohana, Chuo-ku, Chiba-shi, Chiba ,260-8670,Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Aoki |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
260-8670
Address
1-8-1,Inohana, Chuo-ku, Chiba-shi, Chiba ,260-8670,Japan
TEL
043-226-2027
Homepage URL
25fd1101@student.gs.chiba-u.jp
Sponsor or person
Institute
Department of Cognitive Behavioral Physiology ,Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cognitive Behavioral Physiology ,Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
Address
1-8-1,Inohana, Chuo-ku, Chiba-shi, Chiba ,260-8670,Japan
Tel
043-226-2027
neurophys1@ML.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
| 2026 | Year | 02 | Month | 18 | 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 | 12 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069280
