Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062372) titled 'Development and Evaluation of an Arts-Based Verbal and Nonverbal Communication Intervention Program: A Pre-Post Comparative Study Focusing on Self-Isolation Intention, Loneliness, and Mental Health' on July 28.

Study Type: Interventional

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

Primary Sponsor: Institute - University of Tsukuba

Condition: Condition - None Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to develop an art-based verbal and nonverbal communication intervention program in a group format and to examine its effects on enhancing perceived connectedness with others and mood state, and reducing self-isolation intention, loneliness, and isolation outside working hours, using a pre-post design among employees. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention will be conducted as an in-person workshop. The target sample size for the study is 42 participants, with approximately 8-12 participants per group and a total of 4-6 groups. The intervention will be completed in a single day, with a total duration of approximately 5.5 hours, including a 1-hour break and 30 minutes allocated for questionnaire completion before and after the intervention. The program will consist of two sessions, each lasting 120 minutes. The intervention will include several exercises incorporating simple body movements and art-based activities. Specifically, the activities will include a name introduction game, a stone exchange exercise, rhythm and music activities, paired hand improvisation, awareness drawing, group sharing and dialogue, and free writing. The overall structure of the program will follow the sequence: warm-up -> introduction -> theme-based experiential activities -> sharing of experiences -> cool-down. Participants will first engage in nonverbal experiential activities, followed by reflection and verbal sharing of their feelings and insights gained from the experience. Opportunities for dialogue and interaction among participants will also be provided.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Individuals who currently reside in Japan, are aged 20-60 years, and are currently employed by a company or organization. Individuals of any gender, occupation, or employment status. Individuals who are able to communicate basically in Japanese to the extent that they can participate in dialogue and workshop activities without difficulty. Individuals who understand the purpose and procedures of the study and are able to provide written informed consent. Key exclusion criteria - Individuals who have difficulty participating in the mild physical activities planned in the study due to physical reasons. Individuals who have been advised by a physician to restrict exercise or physical activity. Individuals who report that participation in the planned activities (including interpersonal exercises, close physical interactions, and physical contact) may cause significant psychological burden or distress. Individuals for whom it is apparent at the time of obtaining informed consent that continued participation throughout the study period will be difficult. Target Size - 42

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 07 Day Date of IRB - 2026 Year 06 Month 29 Day Anticipated trial start date - 2026 Year 06 Month 29 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071379

Disclaimer: Curated by HT Syndication.