Neurobiological Investigations of Mindfulness, Depression and Sleep Disturbances in Medical Staffs and Community Elders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-90
SponsorTaipei Medical University Shuang Ho Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.-

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Mindfulness-Based Stress Reduction (MBSR) 8-Week Program

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: MBSR groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.
2

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.

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.
3

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.

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.

Secondary outcomes

1

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.

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.
2

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.

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.
3

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.

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.
4

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.

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.

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Ministry of Health and Welfare Shuang-Ho HospitalRecruiting New Taipei City, TaiwanTaiwanTaiwan

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