UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057484 |
|---|---|
| Receipt number | R000065681 |
| Scientific Title | Self-Help Cognitive Behavioral Therapy for Gaze Anxiety in Adolescence: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 18:11:19 |
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Basic information
Public title
Self-Help Cognitive Behavioral Therapies for Gaze Anxiety in Adolescence
Acronym
Self-Help CBTs of Gage Anxiety
Scientific Title
Self-Help Cognitive Behavioral Therapy for Gaze Anxiety in Adolescence: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
Clinical Trail of Self-Help Cognitive Behavioral Therapy for Gaze Anxiety
Region
| Japan |
Condition
Condition
Social Anxiety, Gaze Anxiety
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this trial is to investigate whether self-help cognitive behavioral therapy is effective for gaze anxiety (scopophobia).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The Gaze Anxiety Rating Scale Japanese Version
Key secondary outcomes
Th Liebowitz Social Anxiety Scale Japanese Version
The Social Phobia Inventory Japanese Version
The Patient Health Questionnaire-9 Japanese Version
The Generalized Anxiety Disorder-7 Japanese Version
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self-Help Cognitive Behavioral Therapy by using the Book
Interventions/Control_2
Web-Based Cognitive Behavioral Therapy
Interventions/Control_3
No Treatment Control
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The following are the criteria that all participants must meet: Japanese version of the Gage Anxiety Scale total score > 10, aged between 18 and 30 years old and affiliated with a university, possesses sufficient ICT literacy to send and receive emails, no planned changes in affiliation during the study period.
Key exclusion criteria
The exclusion criteria are as follows: Presence of a mental illness at the time of enrollment, history of suicide attempts, presence of a progressive disease (e.g., cancer), women who are planning pregnancy, currently pregnant, or within 28 days postpartum, and difficulty participating in the study due to antisocial behavior.
Target sample size
328
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakamura |
Organization
Kagoshima University
Division name
Graduate School of Medical and Dental Sciences
Zip code
8908544
Address
1-35-8 Sakuragaoka, Kagoshima-City, Kagoshima, Japan
TEL
0992755111
nakamu36@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Kagoshima University Hospital
Division name
Division of Clinical Psycholgoy
Zip code
8908544
Address
1-35-8 Sakuragaoka, Kagoshima-City, Kagoshima, Japan
TEL
0992755707
Homepage URL
k2782199@kadai.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
This study was supported by the 2024 Kagoshima University Young Researcher Support Grant (representative: KM) was supported.
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
Kagoshima University Hospital
Address
1-35-8 Sakuragaoka, Kagoshima-City, Kagoshima, Japan
Tel
0992755553
crmc@m2.kufm.kagoshima-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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 | 02 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065681
