Mental Health Mood Disturbance Occupational StressMBI-WORKNCT07029022
Monthly Mood Improvement After Workplace Mindfulness
A study testing Mindfulness-Based Intervention (MBI) in people with Mental Health Mood Disturbance Occupational Stress, run by Shinyu Kise at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Mood Disturbance Occupational Stress
- What is being tested?
- Mindfulness-Based Intervention (MBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteJapan
- Study dates
- 21 Jan 2025to 28 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full-time employment
- Age 20 years or older
- Provided written informed consent
Who cannot join
- Current or past psychiatric disorder
- Any medical condition deemed incompatible with study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monthly Trajectories of Mood Improvement Following a Workplace Mindfulness Programme: A Randomised Controlled Pilot Trial
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.
Read the 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.
- Being tested
- Mindfulness-Based Intervention (MBI)
- Keywords
- Mindfulness Workplace Intervention POMS2 Presenteeism Fatigue Pilot Study Randomized Controlled Trial Japan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Intervention (MBI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start21 Jan 2025
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Mood Disturbance Occupational StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shinyu Kise
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shinyu Kise, General Incorporated Foundation Ryukyuseimeisaiseikai, Ryusei Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029022
- Sponsor's protocol ID
- 2024-02
- Acronym
- MBI-WORK
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) underlying the primary and secondary outcome measures will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monthly Trajectories of Mood Improvement Following a Workplace Mindfulness Programme: A Randomised Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07029022
- Acronym / sponsor ID
- MBI-WORK / 2024-02
- Keywords
- Mindfulness Workplace Intervention POMS2 Presenteeism Fatigue Pilot Study Randomized Controlled Trial Japan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Shinyu KiseUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Intervention Group | Experimental | Behavioral: Mindfulness-Based Intervention (MBI)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. |
| 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. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Full-time employment
- Age 20 years or older
- Provided written informed consent
Key exclusion criteria (2 listed)
- Current or past psychiatric disorder
- Any medical condition deemed incompatible with study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness-Based Intervention Group |
Primary outcome
Change in Total Mood Disturbance (TMD)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Institute for Tourism and Health, Ryusei HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) underlying the primary and secondary outcome measures will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Intervention (MBI) in people with Mental Health Mood Disturbance Occupational Stress, run by Shinyu Kise at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Mood Disturbance (TMD) (time frame: Baseline to Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.