UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059579 |
|---|---|
| Receipt number | R000068145 |
| Scientific Title | Exploratory study on the effectiveness of a gaze training system for difficulties with eye contact as a welfare service (support for independence): A pilot single-arm trial |
| Date of disclosure of the study information | 2025/10/29 |
| Last modified on | 2025/10/29 14:01:39 |
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Basic information
Public title
A Study on the Effectiveness of a Gaze Training System for Difficulties in Eye Contact
Acronym
Gaze training to improve eye contact
Scientific Title
Exploratory study on the effectiveness of a gaze training system for difficulties with eye contact as a welfare service (support for independence): A pilot single-arm trial
Scientific Title:Acronym
Evaluation of the Effectiveness of a Gaze Training System for Improving Eye Contact (Pilot Single-Arm Trial)
Region
| Japan |
Condition
Condition
Social anxiety disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the feasibility (safety and effectiveness) of improving difficulties in making eye contact through gaze training using ECOM Light with a general-purpose camera for individuals who face challenges in communication and relationship building, by conducting a single-arm trial. If it is found that gaze training within social skills training conducted in welfare (non-medical) settings can safely improve difficulties in making eye contact, it may lead to enhanced support for independence and is considered to have significant social value.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The examination items for each period are listed below. Pre-evaluation: Week 0Primary evaluation items:- Assessment of the severity of eye contact in daily life (Clinical Global Impression-Severity [CGI-S]): Rated on an 8-point scale where 0 = not assessed, 1 = normal, 2 = borderline, 3 = mild, 4 = moderate, 5 = marked, 6 = severe, and 7 = very severe.- Liebowitz Social Anxiety Scale (LSAS) through a structured interview conducted by the evaluator.Post-evaluation (immediately after intervention): Week 4Primary evaluation items:- Assessment of overall improvement in eye contact in daily life (Clinical Global Impression-Improvement [CGI-I]): Rated on an 8-point scale where 0 = unable to determine, 1 = very much improved, to 7 = very much worsened.- Liebowitz Social Anxiety Scale (LSAS) through a structured interview conducted by the evaluator.Follow-up evaluation (4 weeks after intervention): Week 8Primary evaluation items:- Assessment of improvement in eye contact in daily life by both the study evaluator and supporters (including cohabiting family members) (Clinical Global Impression-Improvement [CGI-I]): Rated on an 8-point scale where 0 = unable to determine, 1 = very much improved, to 7 = very much worsened.
Key secondary outcomes
As secondary evaluation items, self-reported assessments were used, including the SPIN (Social Phobia Inventory) for social anxiety, the PHQ-9 (Patient Health Questionnaire-9) for depression, the GAD-7 (Generalized Anxiety Disorder-7) for generalized anxiety, and the EQ-5D (EuroQol 5 Dimension) for quality of life evaluation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Researchers from Chiba University will visit facilities such as the NPO Cosmos Social Welfare Association (Yachimata City) and Kashiwa Regional Youth Support Station (Kashiwa City), where the trial participants will undergo gaze training using ECOM Lite for more than 5 minutes per session, at least 4 times.
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Individuals who have difficulties with communication and building interpersonal relationships and regularly use welfare facilities, etc. 2) Individuals who are between 16 and 65 years of age at the time of consent 3) Individuals who have received an explanation of the study, understood it, and given written consent 4) Individuals who have difficulty making eye contact 5) Individuals who do not plan to start any new medical treatment during the study period 6) Individuals who can watch a monitor for about 5 to 10 minutes, and are able to continue with 10-minute sessions for 4 weeks of intervention and a subsequent 4-week observation period (follow-up)
Key exclusion criteria
1) Individuals with physical disabilities (including visual and hearing impairments) 2) Others deemed ineligible by the researcher
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University Center for Child Mental Development and Education Research(Graduate School of Medicine, Laboratory of Cognitive Behavioral Physiology)
Division name
Institute of Medical Research
Zip code
260-8670
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
TEL
043-226-2027
neurophys1@ML.chiba-u.jp
Public contact
Name of contact person
| 1st name | Kenshiro |
| Middle name | |
| Last name | Taguchi |
Organization
Osaka University United Graduate School of Child Development
Division name
Institute of Medical Research
Zip code
260-8670
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
TEL
080-2700-7774
Homepage URL
u870828c@ecs.osaka-u.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Operating subsidy
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
Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba City, 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
| 2025 | Year | 10 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068145
