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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Intervention Group | Experimental | Participants in this arm received a workplace mindfulness-based intervention consisting of three 90-minute workshops spaced four weeks apart. The program included psychoeducation, guided stretching, and focused-attention meditation, supplemented by 10-minute daily self-practice and lifestyle guidance. |
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| Wait-list Control Group | No Intervention | Participants in this arm did not receive any intervention during the three-month observation period. They were offered the same mindfulness-based program after the study was completed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Intervention (MBI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Mood Disturbance (TMD) | Total Mood Disturbance (TMD) score derived from the Japanese short form of the Profile of Mood States 2 (POMS2®). Monthly assessments were conducted over a three-month period. Higher scores indicate greater mood disturbance. | Baseline to Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryusei Hospital | Naha | Okinawa | 902-0066 | Japan |
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| Label | URL |
|---|---|
| Institute for Tourism and Health, Ryusei Hospital | View source |
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Deidentified individual participant data (IPD) underlying the primary and secondary outcome measures will be shared.
IPD and supporting documents will be available beginning 6 months after publication of the results and will remain available for 36 months.
Qualified researchers with a methodologically sound proposal may request access to the data. Requests will be reviewed by the study team. A data use agreement will be required prior to data sharing.
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