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

NCT07179172 | Recruiting DMC

• 1 other identifier: N202502057
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbances; Depression

Keywords

Medical personnel; sleep; depression; mental health; preventive medicine; mindfulness; aging; functional magnetic resonance imaging (fMRI); wearable device

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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)

  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

  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 pretest will be conducted within one month prior to the intervention, and the posttest will be conducted within one month following the intervention.

Study Arms (1)

MBSR group

EXPERIMENTAL

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

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

Interventions

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.

MBSR group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.-

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Ministry of Health and Welfare Shuang-Ho Hospital

New Taipei City, Taiwan, Taiwan

RECRUITING

MeSH Terms

Conditions

Parasomnias; Depression; Psychological Well-Being

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jiunn-Kae Wang, MD, MSc

CONTACT

+886970749758; 14073@s.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 17, 2025
• Study Start: June 14, 2025
• Primary Completion: November 8, 2025
• Study Completion: November 8, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)