Monthly Mood Improvement After Workplace Mindfulness

NCT07029022 | Completed

• 1 other identifier: 2024-02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health Mood Disturbance Occupational Stress

Keywords

Mindfulness Workplace Intervention POMS2 Presenteeism Fatigue Pilot Study Randomized Controlled Trial Japan

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Behavioral: Mindfulness-Based Intervention (MBI)

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.

Interventions

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.

Mindfulness-Based Intervention Group

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shinyu Kise: lead

Study Sites (1)

Ryusei Hospital

Naha, Okinawa, 902-0066, Japan

Location

Related Links

• Institute for Tourism and Health, Ryusei Hospital

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator , Institute for Tourism and Health

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 19, 2025
• Study Start: January 21, 2025
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available beginning 6 months after publication of the results and will remain available for 36 months.
• Access Criteria: 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.

Locations

JP (1)