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

NCT ID: NCT07179172

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-14
• Study Completion Date: 2025-11-08

Brief 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 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.

Conditions

Sleep Disturbances; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MBSR group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Hospital staff aged 20-65 years, or elderly individuals aged 55-90 years.

2. Individuals willing to participate in the entire mindfulness course and comply with study enrollment procedures.-

Exclusion Criteria

1. History of major neurological disorders (e.g., epilepsy, Parkinson's disease, stroke).

2. History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder).

3. Use of medications that may affect sleep, other than illegal substances or sleeping pills.

4. Individuals with metal implants.

5. Individuals with claustrophobia.

6. Pregnant women.

7. History of alcohol or substance addiction.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jiunn-Kae Wang, MD, MSc

Role: CONTACT

14073@s.tmu.edu.tw

+886970749758

Facility Contacts

Jiunn-Kae Wang, MD, MSc

Role: primary

14073@s.tmu.edu.tw

+886970749758

Other Identifiers

N202502057

Identifier Type: -

Identifier Source: org_study_id