Tokyo, June 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061822) titled 'A study to examine the effects of virtual reality-based social skills training on interpersonal skills and social functioning in people with schizophrenia' on June 8.

Study Type: Interventional

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

Primary Sponsor: Institute - Teikyo Heisei University

Condition: Condition - Schizophrenia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Treatment and care Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants in the VR-SST group will receive VR-SST using FACEDUO once a week for 60 minutes over six months, for a total of 24 sessions. The program consists of 19 mandatory contents and 5 optional contents selected according to each participant's needs and preferences.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Participants must meet all of the following criteria: 1. Patients who meet the DSM-5 diagnostic criteria for schizophrenia 2. Patients who have been stably attending psychiatric day care for at least one month 3. Patients aged 18 years or older and under 60 years 4. Patients judged by their attending psychiatrist to be able to participate in the study 5. Patients who receive an explanation of the study and provide written informed consent Key exclusion criteria - Exclusion Criteria Patients who meet any of the following criteria will be excluded: 1. Patients who have difficulty understanding the study and cannot provide sufficient informed consent 2. Patients whose capacity to consent is considered uncertain based on confirmation of understanding during the explanation process 3. Patients whose psychiatric symptoms are unstable and who are judged by their attending psychiatrist to be unsuitable for participation 4. Patients who score 1 or higher on item 9 of the PHQ-9, which assesses suicidal ideation 5. Patients with a history of seizure disorders, including epilepsy 6. Patients with a history of severe motion sickness or who are expected to be at high risk of VR sickness 7. Patients with severe cognitive impairment or other conditions that make participation in VR-SST difficult 8. Patients with intellectual disability Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 28 Day Date of IRB - 2026 Year 02 Month 08 Day Anticipated trial start date - 2026 Year 06 Month 08 Day Last follow-up date - 2028 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070679

Disclaimer: Curated by HT Syndication.