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NCT Number: NCT07186023

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

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.

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Key information

Conditions

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

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shuang Ho Biomedical Park, Taipei Medical University, New Taipei City, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for individuals participating in mindfulness-based Interventions:

  • 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.

Exclusion criteria

for individuals participating in mindfulness-based Interventions:

  • 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.

Inclusion criteria

for individuals participating in brain stimulation Intervention:

  • 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.

Exclusion criteria

for individuals participating in brain stimulation Intervention:

  • 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.

Treatment and study plan

MBSR

Behavioral

Mindfulness-Based Stress Reduction

MBWC

Behavioral

Mindfulness-Based Well-Being Curriculum

MBCI

Behavioral

Mindfulness-Based Curriculum for Insomnia

BSI

Device

Brain Stimulation Intervention

Primary outcomes

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

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

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

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

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

    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).

Secondary outcomes

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

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

    Statistically significant alterations in regional gray matter volume (measured in cubic millimeters), thickness (measured in millimeters) or density (represented as a percentage between 0 and 1) compared to baseline measurements.

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

    Time frame: 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).

    Statistically significant changes across 3 time points using WAIS across subsets of facial memory test and (scores between 0 and 48), digit span in forward (scores between 0 and 16) and backward order (scores between 0 and 14), block design (scores between 0 and 68), digit symbol-coding (scores between 0 and 133).

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

    Time frame: 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).

    Statistically significant changes across 3 time points using Verbal fluency scores in categories of colors, animals, cities, and fruits.

  4. Changes in the depression scale

    Time frame: 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).

    Depression scale changes measured by the geriatric depression scale (scores between 0 and 15) and the 17-item Hamilton depression rating scale (scores between 0 and 52) across 3 time points.

  5. Changes in anxiety scale

    Time frame: 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).

    Anxiety scale changes measured by the Hamilton anxiety rating scale (scores between 0 and 48) across 3 time points.

  6. Changes in the loneliness scale

    Time frame: 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 of the loneliness scale developed by the University of California, Los Angeles, across 3 time points

  7. Changes in perceived stress

    Time frame: 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 of the 14-item perceived stress scale (scores between 0 and 56) across 3 time points

  8. Changes in the apathy scale

    Time frame: 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 of the 18-item apathy evaluation scale (scores between 0 and 72) across 3 time points

  9. Changes in self-reported sleep outcomes assessed through sleepiness and sleep quality

    Time frame: 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 of the 3-item insomnia severity index for sleepiness (scores between 0 and 28) and the 10-item Pittsburgh Sleep Quality Index for sleep quality across 3 time points

  10. Changes in self-reported intervention outcomes in terms of mindfulness, flourishing, and well-being

    Time frame: 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 of Intervention outcomes assessed by the 39-item five-facet mindfulness questionnaire, 30-item flourishing scale across 5 domains (mercifulness, playfulness, respectfulness, peacefulness, healthfulness), and two forms of well-being scale (short and long forms) across 3 time points. The short form is the World Health Organization-five well-being index (scores between 0 and 25). The long form is a 29-item well-being scale for the elderly in Taiwan (scores between 0 and 145).

  11. Dynamic patterns of objective sleep parameters assessed through smart watch monitoring

    Time frame: Continuous physiological monitoring conducted from 4 weeks pre-intervention through 4 weeks post-completion of the 1-month follow-up period (total monitoring duration: 16 weeks).

    Dynamic patterns of sleep indices (including sleep stage duration, sleep onset latency, and sleep efficiency), measured by a smart watch from baseline through to 1-month follow-up assessments.

  12. Dynamic patterns of objective cardiovascular parameters assessed through smart watch monitoring

    Time frame: Continuous physiological monitoring conducted from 4 weeks pre-intervention through 4 weeks post-completion of the 1-month follow-up period (total monitoring duration: 16 weeks).

    Dynamic patterns of indices deriving from heart rate (including heart rate variability and stress), measured by a smart watch, from baseline through to 1-month follow-up assessments.

Study contacts

Contact information is provided by the study sponsor or research team.

Ai-Ling Hsu, PhD.

CONTACT

[email protected]

+886-5-6327369 ext. 143

Changwei W. Wu, PhD.

CONTACT

[email protected]

+886-2-66202589 ext. 10518

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Registry information

Official study title

Intervention Evaluation for Late-life Depression in Taiwan Urban and Rural Areas: Long-term Tracking and Prediction of Non-pharmaceutical Interventions by Smart AI Technologies

Acronym: PredictNPI

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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