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临床试验/NCT07029022
NCT07029022已完成不适用

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

Shinyu Kise1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Change in Total Mood Disturbance (TMD)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •Current or past psychiatric disorder
  • •Any medical condition deemed incompatible with study participation

研究组 & 干预措施

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.

干预措施: Mindfulness-Based Intervention (MBI) (Behavioral)

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.

结局指标

主要结局

Change in Total Mood Disturbance (TMD)

时间窗: Baseline to Month 3

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.

次要结局

未报告次要终点

研究者

发起方
Shinyu Kise
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shinyu Kise

Principal Investigator , Institute for Tourism and Health

General Incorporated Foundation Ryukyuseimeisaiseikai, Ryusei Hospital.

研究点 (1)

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