Tokyo, Oct. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059579) titled 'A Study on the Effectiveness of a Gaze Training System for Difficulties in Eye Contact' on Oct. 29.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Chiba University

Condition: Condition - Social anxiety disorder Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 16 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 Size - 10

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068145

Disclaimer: Curated by HT Syndication.