Monthly Mood Improvement After Workplace Mindfulness

NCT ID: NCT07029022

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-21

Study Completion Date

2025-04-28

Brief Summary

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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.

Detailed Description

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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

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Mental Health Mood Disturbance Occupational Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness-Based Intervention Group

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.

Group Type EXPERIMENTAL

Mindfulness-Based Intervention (MBI)

Intervention Type 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.

Wait-list Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Full-time employment
* Age 20 years or older
* Provided written informed consent

Exclusion Criteria

* Current or past psychiatric disorder
* Any medical condition deemed incompatible with study participation
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shinyu Kise

OTHER

Sponsor Role lead

Responsible Party

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Shinyu Kise

Principal Investigator , Institute for Tourism and Health

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ryusei Hospital

Naha, Okinawa, Japan

Site Status

Countries

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Japan

Related Links

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https://www.ryusei.or.jp/checkup/Consulting#description-con-1

Institute for Tourism and Health, Ryusei Hospital

Other Identifiers

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2024-02

Identifier Type: -

Identifier Source: org_study_id

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