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

Official 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

Overview

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.

Interventions

• Behavioral MBSR
  Mindfulness-Based Stress Reduction
• Behavioral MBWC
  Mindfulness-Based Well-Being Curriculum
• Behavioral MBCI
  Mindfulness-Based Curriculum for Insomnia
• Device BSI
  Brain Stimulation Intervention

Primary outcome measures

• 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.]
• 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.]

Secondary outcome measures (12)

• 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.]
• 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).]
• 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).]
• 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).]
• 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).]
• 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 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 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 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 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).]
• 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 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).]

Eligibility criteria

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.

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

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Taiwan · 2 centers

• Shuang Ho Biomedical Park, Taipei Medical University — New Taipei City
• National Center for Geriatrics and Welfare Research — Yunlin

Identifiers

NCT: NCT07186023 · EC1140405 · CG-114-GP-23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗