Sleep DisturbancesNIMDSNCT07179172
Neurobiological Investigations of Mindfulness, Depression and Sleep Disturbances in Medical Staffs and Community Elders
A study testing Mindfulness-Based Stress Reduction (MBSR) 8-Week Program in people with Sleep Disturbances and Depression, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
The research team proposes a multi-year study with the first year focusing on the developmental phase. In this initial phase, we aim to recruit 40 participants (including healthcare staff and older adults) from Shuang-Ho Hospital and the surrounding community to undergo two mindfulness intervention sessions, each… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbances, Depression
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR) 8-Week Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jun 2025to 31 May 2026
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospital staff aged 20-65 years, or elderly individuals aged 55-90 years.
- Individuals willing to participate in the entire mindfulness course and comply with study enrollment procedures.-
Who cannot join
- History of major neurological disorders (e.g., epilepsy, Parkinson's disease, stroke).
- History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder).
- Use of medications that may affect sleep, other than illegal substances or sleeping pills.
- Individuals with metal implants.
- Individuals with claustrophobia.
- Pregnant women.
- History of alcohol or substance addiction.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City, Taiwan
About this study
The research team proposes a multi-year study with the first year focusing on the developmental phase. In this initial phase, we aim to recruit 40 participants (including healthcare staff and older adults) from Shuang-Ho Hospital and the surrounding community to undergo two mindfulness intervention sessions, each lasting four months. We anticipate that these interventions will prevent and alleviate stress and depressive symptoms while enhancing self-awareness and psychological health.
Read the detailed description
Mindfulness-based interventions (MBI) have capability to effectively reduce anxiety, alleviate stress responses, and decrease negative emotional states and rumination. However, the majority of studies have predominantly focused on younger populations or university students, utilizing subjective scales as assessment tools. Noticeable scarcity of studies is in need to implement mindfulness programs among healthcare staff and elderly patients experiencing depression, despite these groups exhibiting urgent needs for improving mental health. This research project aims to introduce MBI within a healthcare setting to effectively alleviate workplace stress, enhance self-awareness, and improve sleep quality or psychological well-being among medical personnel. Additionally, this initiative targets mental health issues in older adults by recruiting participants from the community surrounding Shuang-Ho Hospital. The program aims to prevent depression, delay cognitive decline, and reduce suicide risk while providing continuous opportunities for personal growth among the senior adults. This effort aligns well with Taiwan government initiatives promoting social support and long-term care in the over-aging societies and lays the groundwork for quantitative research on MBI for older adults.
The research team proposes a multi-year study with the first year focusing on the developmental phase. In this initial phase, we aim to recruit 40 participants (including healthcare staff and older adults) from Shuang-Ho Hospital and the surrounding community to undergo two mindfulness intervention sessions, each lasting four months. We anticipate that these interventions will prevent and alleviate stress and depressive symptoms while enhancing self-awareness and psychological health. To explore the neurophysiological effects of mindfulness courses, we will employ advanced technologies, including non-invasive fiber optic physiological monitoring (nFOPT), wearable Garmin smartwatches, and functional magnetic resonance imaging (fMRI), to observe changes in participants' central and peripheral nervous systems throughout the intervention. fMRI will elucidate the central modulatory effects of mindfulness on neural function, while Garmin smartwatches will provide continuous physiological data monitoring. Coupling these methods with nFOPT and the Belun ring will allow for comprehensive sleep quality assessments. This interdisciplinary approach addresses the limitations of prior qualitative-focused mindfulness research. Ultimately, this study aims to advance the care of healthcare workers, fulfill social responsibilities associated with university outreach, and make significant contributions world-wide to both the academic fields of mindfulness and neuroscience.
- Conditions
- Sleep Disturbances, Depression
- Being tested
- Mindfulness-Based Stress Reduction (MBSR) 8-Week Program
- Keywords
- Medical personnel, sleep, depression, mental health, preventive medicine, mindfulness, aging, functional magnetic resonance imaging (fMRI), wearable device
- Medical subject headings
- Parasomnias, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR) 8-Week ProgramBehavioural
The program consists of weekly 2.5-hour sessions over an eight-week period. The certified mindfulness instructor will follow a curriculum that includes in-class formal practice (2.5 hours) and assigned informal practice (30-40 minutes daily).
During the sessions, the instructor will guide participants through mindfulness meditation, pain awareness, mindful yoga, gratitude practice, loving-kindness meditation, and the sharing of daily life experiences. Additionally, a full-day, eight-hour silent retreat (9 a.m. to 5 p.m.) will be held between weeks six and seven to deepen inner awareness.
Following each weekly group session, participants will be instructed to perform and self-record daily home practice, which will be discussed and evaluated during the following week's class. The total course duration is approximately 26 hours, and participants will receive a certificate of completion upon graduation.
| Study group | Role | What they receive |
|---|---|---|
| MBSR group | Experimental | Mindfulness-Based Stress Reduction (MBSR) 8-Week Program Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) 8-Week Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taiwan Geriatric depression scale (TGDS)
A self-report scale collected through an online questionnaire, with a minimum score of 0 and a maximum score of 15, where higher scores indicate more depressive symptoms.
Measured: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
Pittsburgh Sleep Quality Index (PSQI)
A self-report questionnaire that assesses sleep quality and disturbances over a 1-month period. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 suggests poor sleep quality.
Measured: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
The World Health Organization-Five Well-Being Index (WHO-5)
A short self-report questionnaire consisting of 5 items that assess subjective psychological well-being over the past two weeks. Each item is scored on a 6-point Likert scale (0 = at no time to 5 = all of the time). The raw total score ranges from 0 to 25, with higher scores indicating better well-being. A score below 13 suggests poor well-being and may indicate risk of depression.
Measured: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
Secondary outcomes (4)
Polysomnography (PSG) for slow-wave sleep
PSG is an objective, overnight sleep study that records multiple physiological parameters to evaluate sleep architecture and detect sleep disorders. This study aims to use PSG to determine the amount of slow-wave sleep (SWS) among total sleep time. SWS, also known as deep sleep or NREM stage 3 (N3), is considered the most restorative stage of sleep. The normal range for SWS in adults is generally 10% to 20% of total sleep time, equating to about 40 to 110 minutes for those who sleep 7 to 9 hours per night.
Measured: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
Functional Magnetic Resonance Imaging (fMRI)
A non-invasive neuroimaging technique that measures brain activity by detecting blood oxygen level-dependent (BOLD) signal changes associated with neural activity. fMRI allows assessment of both task-related activation (e.g., responses to cognitive or emotional stimuli) and resting-state functional connectivity (e.g., interactions between large-scale brain networks). Key physiological indicators include:
BOLD signal fluctuations reflecting regional brain activity. Functional connectivity metrics (e.g., correlations between brain regions). Task-related activation patterns in specific cortical and subcortical areas. Derived indices such as amplitude of low-frequency fluctuations (ALFF), regional homogeneity (ReHo), and network efficiency.
Higher or more coherent activation/connectivity generally indicates more efficient neural processing, while abnormal patterns may suggest dysfunction in mood regulation, cognition, or sleep-wake processes.
Measured: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
non-invasive fiber optic physiological monitoring (nFOPT) for respiratory patterns
A novel non-invasive monitoring technique that uses fiber optic sensors to continuously measure physiological signals with high sensitivity and stability. This technology aims to investigate respiratory patterns during sleep. Higher irregularity in respiratory patterns may indicate poorer physiological regulation, while stable and coherent signals suggest healthier sleep and autonomic function.
Measured: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
Belun Ring for sleep apnea
The prevalence and distribution of OSA across different severity levels will be evaluated using the apnea-hypopnea index/respiratory event index derived from the Belun Ring (bAHI). Belun Ring is a wearable, non-invasive device designed to continuously monitor physiological signals during daily life and sleep. It uses optical and motion sensors to provide detailed data on autonomic and sleep-related parameters. The severity of OSA is categorized based on the bAHI as follows: Normal: bAHI < 5 events/hour; Mild OSA: bAHI between 5 and 15 events/hour; Moderate OSA: bAHI between 15 and 30 events/hour; Severe OSA: bAHI > 30 events/hour.
Measured: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start14 Jun 2025
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbancesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179172
- Sponsor's protocol ID
- N202502057
- Acronym
- NIMDS
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Investigations of Mindfulness, Depression and Sleep Disturbances in Medical Staffs and Community Elders
- ClinicalTrials.gov ID
- NCT07179172
- Acronym / sponsor ID
- NIMDS / N202502057
- Conditions
- Sleep Disturbances, Depression
- Keywords
- Medical personnel, sleep, depression, mental health, preventive medicine, mindfulness, aging, functional magnetic resonance imaging (fMRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 14 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 17 Sep 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.
The research team proposes a multi-year study with the first year focusing on the developmental phase. In this initial phase, we aim to recruit 40 participants (including healthcare staff and older adults) from Shuang-Ho Hospital and the surrounding community to undergo two mindfulness intervention sessions, each lasting four months. We anticipate that these interventions will prevent and alleviate stress and depressive symptoms while enhancing self-awareness and psychological health.
Detailed description
Mindfulness-based interventions (MBI) have capability to effectively reduce anxiety, alleviate stress responses, and decrease negative emotional states and rumination. However, the majority of studies have predominantly focused on younger populations or university students, utilizing subjective scales as assessment tools. Noticeable scarcity of studies is in need to implement mindfulness programs among healthcare staff and elderly patients experiencing depression, despite these groups exhibiting urgent needs for improving mental health. This research project aims to introduce MBI within a healthcare setting to effectively alleviate workplace stress, enhance self-awareness, and improve sleep quality or psychological well-being among medical personnel. Additionally, this initiative targets mental health issues in older adults by recruiting participants from the community surrounding Shuang-Ho Hospital. The program aims to prevent depression, delay cognitive decline, and reduce suicide risk while providing continuous opportunities for personal growth among the senior adults. This effort aligns well with Taiwan government initiatives promoting social support and long-term care in the over-aging societies and lays the groundwork for quantitative research on MBI for older adults.
The research team proposes a multi-year study with the first year focusing on the developmental phase. In this initial phase, we aim to recruit 40 participants (including healthcare staff and older adults) from Shuang-Ho Hospital and the surrounding community to undergo two mindfulness intervention sessions, each lasting four months. We anticipate that these interventions will prevent and alleviate stress and depressive symptoms while enhancing self-awareness and psychological health. To explore the neurophysiological effects of mindfulness courses, we will employ advanced technologies, including non-invasive fiber optic physiological monitoring (nFOPT), wearable Garmin smartwatches, and functional magnetic resonance imaging (fMRI), to observe changes in participants' central and peripheral nervous systems throughout the intervention. fMRI will elucidate the central modulatory effects of mindfulness on neural function, while Garmin smartwatches will provide continuous physiological data monitoring. Coupling these methods with nFOPT and the Belun ring will allow for comprehensive sleep quality assessments. This interdisciplinary approach addresses the limitations of prior qualitative-focused mindfulness research. Ultimately, this study aims to advance the care of healthcare workers, fulfill social responsibilities associated with university outreach, and make significant contributions world-wide to both the academic fields of mindfulness and neuroscience.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBSR group | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR) 8-Week ProgramMindfulness-Based Stress Reduction (MBSR) 8-Week Program |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospital staff aged 20-65 years, or elderly individuals aged 55-90 years.
- Individuals willing to participate in the entire mindfulness course and comply with study enrollment procedures.-
Key exclusion criteria (7 listed)
- History of major neurological disorders (e.g., epilepsy, Parkinson's disease, stroke).
- History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder).
- Use of medications that may affect sleep, other than illegal substances or sleeping pills.
- Individuals with metal implants.
- Individuals with claustrophobia.
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 Stress Reduction (MBSR) 8-Week ProgramThe program consists of weekly 2.5-hour sessions over an eight-week period. The certified mindfulness instructor will follow a curriculum that includes in-class formal practice (2.5 hours) and assigned informal practice (30-40 minutes daily). During the sessions, the instructor will guide participants through mindfulness meditation, pain awareness, mindful yoga, gratitude practice, loving-kindness meditation, and the sharing of daily life experiences. Additionally, a full-day, eight-hour silent retreat (9 a.m. to 5 p.m.) will be held between weeks six and seven to deepen inner awareness. Following each weekly group session, participants will be instructed to perform and self-record daily home practice, which will be discussed and evaluated during the following week's class. The total course duration is approximately 26 hours, and participants will receive a certificate of completion upon graduation. | Behavioural | MBSR group |
Primary outcome
Taiwan Geriatric depression scale (TGDS)
Time frame: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
A self-report scale collected through an online questionnaire, with a minimum score of 0 and a maximum score of 15, where higher scores indicate more depressive symptoms.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
A self-report questionnaire that assesses sleep quality and disturbances over a 1-month period. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 suggests poor sleep quality.
The World Health Organization-Five Well-Being Index (WHO-5)
Time frame: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
A short self-report questionnaire consisting of 5 items that assess subjective psychological well-being over the past two weeks. Each item is scored on a 6-point Likert scale (0 = at no time to 5 = all of the time). The raw total score ranges from 0 to 25, with higher scores indicating better well-being. A score below 13 suggests poor well-being and may indicate risk of depression.
4 secondary outcomes
Polysomnography (PSG) for slow-wave sleep
Time frame: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
Functional Magnetic Resonance Imaging (fMRI)
Time frame: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
non-invasive fiber optic physiological monitoring (nFOPT) for respiratory patterns
Time frame: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
Belun Ring for sleep apnea
Time frame: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.
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 28 Aug 2026.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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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 Stress Reduction (MBSR) 8-Week Program in people with Sleep Disturbances and Depression, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 2 inclusion and 7 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 28 Aug 2026. 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 Taiwan. 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?
Taiwan Geriatric depression scale (TGDS) (time frame: The pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.). The study lists 3 primary outcomes in all. 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 28 Aug 2026.