Clinical Trial: Human-Supported Digital Acceptance and Commitment Therapy (dACT-G) Program for Japanese Workers at Risk of Burnout: A Two-Arm Parallel-Group Randomized Controlled Trial (Japan)

Tokyo, Sept. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063055) titled 'Hybrid Digital Intervention Facilitating Valued Action for Workplace Mental Health' on Sept. 26.

Study Type: Interventional

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

Primary Sponsor: Institute - University of Occupational and Environmental Health, Japan

Condition: Condition - Workers from the general working population at risk of burnout Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to examine whether a human-supported hybrid digital intervention based on acceptance and commitment therapy (dACT-G), a cognitive-behavioral approach, reduces burnout compared with a waitlist control among workers from the general working population at risk of burnout, using a two-arm parallel-group randomized controlled trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intervention group: dACT-G dACT-G is a program based on acceptance and commitment therapy (ACT), a cognitive-behavioral approach, that combines a digital tool with human support. The intervention lasts 5 weeks, starting on the day of the initial one-to-one session. Participants complete the following components online.

(1) At the start of the program, a one-to-one session (approximately 30 minutes, via a web conferencing system) with a staff member to clarify goals and schedule the weekly sessions. (2) Five weekly pre-recorded video sessions (approximately 30 minutes each) with exercises, delivered through a web- and mobile-based digital tool. (3) A weekly online Q&A webinar during the intervention period. Participants may attend live or watch the recording. (4) At the end of the program, a one-to-one session (approximately 15 minutes, via a web conferencing system) with a staff member to review the program as a whole. Interventions/Control_2 - Waitlist control group Participants receive no study intervention during the 5-week intervention period. After all participants in the intervention group have completed the intervention, they are offered the program without the one-to-one sessions (the video sessions and the Q&A webinars).

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - - 18 years of age or older - Able to answer the questionnaires and participate in the program in Japanese - Employed - Mean score of 2.59 or higher on the BAT-J (at risk of burnout) Key exclusion criteria - - Individuals who do not meet one or more of the inclusion criteria - Currently on leave of absence or planning to take leave of absence - QIDS-J total score of 21 or higher (very severe), or high suicide risk (score of 2 or higher on QIDS-J item 12, thoughts of death or suicide) - BAT-J score of less than 2.59 - Prior exposure to the intervention program used in this study - Individuals receiving outpatient treatment for a mental disorder who have not obtained permission to participate from their attending physician Target Size - 300

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 15 Day Date of IRB - 2026 Year 07 Month 10 Day Anticipated trial start date - 2026 Year 10 Month 07 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=R000071788

Disclaimer: Curated by HT Syndication.