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Recruiting NCT07179172

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

No phase Interventional Sleep Disturbances Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-Based Stress Reduction (MBSR) 8-Week Program.
Who it may be relevant to
Registry conditions: Sleep Disturbances, Depression. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (4)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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.-

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Ministry of Health and Welfare Shuang-Ho Hospital — New Taipei City

Identifiers

NCT: NCT07179172 · N202502057

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗