NCT07029022

Monthly Mood Improvement After Workplace Mindfulness

Monthly Trajectories of Mood Improvement Following a Workplace Mindfulness Programme: A Randomised Controlled Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Shinyu Kise · Academic / Other
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled pilot trial investigates the effects of a brief workplace mindfulness-based intervention (MBI) on mood among full-time employees in Japan. Twenty-five participants are randomly assigned to either the MBI group or a wait-list control group. The MBI group receives three 90-minute workshops spaced four weeks apart, along with daily home mindfulness practice. Mood is assessed monthly over three months using the Japanese version of the Profile of Mood States 2 (POMS2). The primary outcome is Total Mood Disturbance (TMD). This study is approved by the Ryusei Hospital Institutional Review Board and conducted as a feasibility trial.

Detailed description

This pilot randomized controlled trial aims to evaluate the month-by-month effects of a low-intensity workplace mindfulness-based intervention (MBI) on mood among full-time employees in a healthcare setting in Okinawa, Japan. Participants are assigned in a 1:1 ratio to either the MBI group or a wait-list control group. The intervention consists of three 90-minute in-person workshops delivered at monthly intervals, incorporating psychoeducation, guided stretching, and focused-attention meditation. Participants in the MBI arm are also encouraged to practice mindfulness at home for 10 minutes per day. Mood is assessed at baseline and monthly over three months using the Japanese POMS2 Short Form. The primary endpoint is change in Total Mood Disturbance (TMD); secondary outcomes include fatigue (measured via a visual analogue scale) and presenteeism (measured via Single-Item Presenteeism Question, the University of Tokyo single-item edition (SPQ) ). Linear mixed-effects models are used for statistical analysis. The study is approved by the Ryusei Hospital Institutional Review Board (Approval No. 2024-02) and conducted as a feasibility study without prospective registration.

Conditions

• Mental Health Mood Disturbance Occupational Stress

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-Based Intervention (MBI)	This intervention consisted of three 90-minute in-person workshops delivered monthly over a three-month period. Content included psychoeducation, guided stretching, and focused-attention meditation. Participants were also encouraged to practice mindfulness at home for 10 minutes daily and to follow lifestyle guidance on diet and physical activity.

Timeline

• Start date: 2025-01-21
• Primary completion: 2025-04-28
• Completion: 2025-04-28
• First posted: 2025-06-19
• Last updated: 2025-06-24

Locations

1 site across 1 country: Japan