Clinical Trial: Evaluation of the Effects and Practicality of a Desktop AI Robot INU Intervention for Reducing Loneliness, Depression, and Anxiety and Improving Self-Esteem Among Young and Middle-Aged to Older Adults Engaged in Desk Work (Japan)

Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062735) titled 'Effects of a Desktop AI Robot Intervention on Reducing Loneliness, Depression and Anxiety, and Improving Self-Esteem Among Students and Workers Engaged in Desk Work' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - Kumamoto University

Condition: Condition - Healthy students or workers aged 13-65 years who engage in desk work for at least 2 hours per da Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In recent years, loneliness and social isolation among adolescents and young people, as well as middle-aged and older adults of working age, have become major social issues. Accumulating evidence suggests that loneliness and social isolation may have a substantial impact on the development of depression and dementia. Although the allocation of human resources is often considered as a means of addressing these issues, such approaches may be limited by regional disparities and the availability of human resources. In this study, a desktop robot (INU) developed by Ludens AI Inc., which can be easily installed and provides interactive and monitoring functions, will be used as intervention tool. Students and workers who engaged in desk work on a daily basis will receive intervention in which INU is installed in their work or study environment for a predetermined period.As a control intervention, a stuffed toy of the same size as INU will be installed for the same period. The primary objectives of this preliminary study are to assess the feasibility and safety of the AI robot intervention and the feasibility of implementing the primary outcome measures, as well as to preliminarily investigate the effects of the intervention on loneliness, depression, anxiety, and low self-esteem among the target population.After completion of the intervention period, the outcomes of the AI robot intervention group and the control group will be compared to evaluate the effects and feasibility of the intervention. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intervention Group (n=15) 1.Before the intervention, participants will undergo psychological assessments of loneliness, depression, anxiety, self-esteem, and resilience using the following scales: Patient Health Questionnaire-9 (PHQ-9; PHQ-A for participants under 18 years of age), Generalized Anxiety Disorder-7 (GAD-7), Rosenberg Self-Esteem Scale (RSES), and Resilience Scale-14 (RS-14). Saliva samples will also be collected to measure and evaluate salivary oxytocin concentration as an indicator of interpersonal relationships and salivary cortisol concentration as an indicator of stress. 2.Participants will place the desktop AI robot INU on their desk at home, in a study room, or at their workplace while engaged in desk work. They will spend 2 hours per day interacting with INU and receiving monitoring and other forms of engagement from INU, from Monday through Friday, for 28 days. 3.After completion of the intervention period, participants will be reassessed using the same outcome measures and biological indicators as those administered before the intervention. Interventions/Control_2 - Control group (n=15) 1.Before the intervention, participants will undergo psychological assessments of loneliness, depression, anxiety, self-esteem, and resilience using the following scales: Patient Health Questionnaire-9 (PHQ-9; PHQ-A for participants under 18 years of age), Generalized Anxiety Disorder-7 (GAD-7), Rosenberg Self-Esteem Scale (RSES), and Resilience Scale-14 (RS-14). Saliva samples will also be collected to measure and evaluate salivary oxytocin concentration as an indicator of interpersonal relationships and salivary cortisol concentration as an indicator of stress. 2. Participants will place a stuffed toy of the same size as INU on their desk while performing desk work at home, in a study room, or at their workplace. Participants will keep the stuffed toy nearby 2 hours per day, from Monday to Friday, for 28 days. 3.After completion of the intervention period, participants will be reassessed using the same outcome measures and biological indicators as those administered before the intervention.

Eligibility: Age-lower limit - 13 years-old = Gender - Male and Female Key inclusion criteria - 1.Students or workers aged 13 to 65 years. 2.Engagement in desk work for at least 2 hours per day. 3.Age of 13 to 65 years at the time of informed consent. 4.Ability to provide voluntary written and verbal informed consent to participate in the study, or to have the same willingness to participate confirmed by an appropriate legally authorized representative. Key exclusion criteria - 1.Severe visual or hearing impairment, or aphasia, making it difficult to undergo the study intervention or assessments. 2.Inability to provide appropriate informed consent due to cognitive impairment, mental illness, or other conditions. 3.Other circumstances considered inappropriate for study participation by the principal investigator or co-investigators. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 09 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071833

Disclaimer: Curated by HT Syndication.