Effects of Mindfulness or Brain Stimulation Intervention for Late-life Adults in Taiwan Urban and Rural Areas

NCT07186023 | Recruiting DMC

• 2 other identifiers: EC1140405CG-114-GP-23
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized controlled trial will examine the effects of mindfulness-based interventions and brain stimulation interventions on cognitive function and psychological well-being in older adults. The study will employ a comprehensive assessment approach incorporating psychological evaluations, behavioral assessments, psychophysiological measurements, and neuroimaging analyses to characterize the outcome of nonpharmaceutical interventions in improving geriatric well-being or reducing depression severity.

Conditions

Late-Life Adults; Late-Life Prodromal Depression; Late-Life Depression; Mindfulness; Brain Stimulation Intervention

Outcome Measures

Primary Outcomes (2)

• Changes in neural activation related to emotional processing, sensory processing, attention, and memory-related brain regions.

  Significant alterations in blood oxygen level-dependent (BOLD) signal amplitude during task-based functional magnetic resonance imaging (fMRI).

  Baseline assessment conducted during the 4-week period prior to intervention initiation; follow-up assessment conducted during the 4-week period following intervention completion.

• Changes in resting-state functional connectivity within and between brain networks

  Statistically significant alterations in intrinsic functional connectivity parameters derived from blood-oxygen-level-dependent (BOLD) signals acquired during resting-state functional magnetic resonance imaging (rs-fMRI).

  Baseline assessment conducted during the 4-week period prior to intervention initiation; follow-up assessment conducted during the 4-week period following intervention completion.

Secondary Outcomes (12)

• Regional brain morphometric changes, assessed by quantitative analysis of gray matter volume, thickness, and density differences using high-resolution structural magnetic resonance imaging.

  Baseline assessment conducted during the 4-week period prior to intervention initiation; follow-up assessment conducted during the 4-week period following intervention completion.

• Self-reported neuropsychological outcomes assessed through validated Wechsler Adult Intelligence Scale (WAIS).

  Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).

• Scores of the total number of category-naming items correctly named within one minute for testing verbal fluency.

  Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).

• Changes in the depression scale

  Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).

• Changes in anxiety scale

  Baseline (within 4 weeks pre-intervention), immediate post-intervention (within 1 week of completion), and 1-month follow-up (within 1 week of the 1-month milestone).

Study Arms (4)

MBSR

ACTIVE COMPARATOR

Mindfulness-Based Stress Reduction

Behavioral: MBSR

MBWC

ACTIVE COMPARATOR

Mindfulness-Based Well-Being Curriculum

Behavioral: MBWC

MBCI

ACTIVE COMPARATOR

Mindfulness-Based Curriculum for Insomnia

Behavioral: MBCI

BSI

OTHER

Brain Stimulation Intervention

Device: BSI

Interventions

MBSR BEHAVIORAL

Mindfulness-Based Stress Reduction

MBSR

MBWC BEHAVIORAL

Mindfulness-Based Well-Being Curriculum

MBWC

MBCI BEHAVIORAL

Mindfulness-Based Curriculum for Insomnia

MBCI

BSI DEVICE

Brain Stimulation Intervention

BSI

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Literate or have received an education above the elementary level.
• Have normal or corrected vision and hearing, able to communicate and understand explanations.
• Right-handed individuals as assessed by the Edinburgh Handedness Inventory.

You may not qualify if:

• Individuals with dementia, stroke, cerebrovascular disease, brain injury, epilepsy, or Parkinson's disease.
• Individuals with neurological system disorders.
• Individuals with alcohol or drug dependence.
• Individuals with other major physical illnesses, such as diabetes, heart failure, or endocrine abnormalities, or those who have experienced an acute myocardial infarction within the past three months.
• Individuals with metal objects in the body that cannot undergo magnetic resonance imaging (MRI), such as cardiac pacemakers, vascular clips, hearing aids, artificial joints, steel pins, etc.
• Individuals with Claustrophobia.
• Individuals in pregnancy or possibility of pregnancy.
• Individuals diagnosed with major depressive disorder by psychiatrists according to the Diagnostic and Statistical Manual, and who can cooperate with the psychiatric outpatient clinic regulations.
• Literate or have received an education above the elementary level.
• Have normal or corrected vision and hearing, able to communicate and understand explanations.
• Right-handed individuals as assessed by the Edinburgh Handedness Inventory.
• Individuals are prescribed brain stimulation therapy by clinical physicians.
• Individuals with dementia, stroke, cerebrovascular disease, brain injury, epilepsy, or Parkinson's disease.
• Individuals with neurological system disorders.
• Individuals with alcohol or drug dependence.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (2)

Shuang Ho Biomedical Park, Taipei Medical University

New Taipei City, 235603, Taiwan

RECRUITING

National Center for Geriatrics and Welfare Research

Yunlin, 632007, Taiwan

NOT YET RECRUITING

Central Study Contacts

Ai-Ling Hsu, PhD.

CONTACT

+886-5-6327369; alhsu@nhri.edu.tw

Changwei W. Wu, PhD.

CONTACT

+886-2-66202589; sleepbrain@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Investigator

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)