Brain Stimulation Intervention, Late-Life Adults, Late-Life Depression, Late-Life Prodromal Depression, Mindfulness
Conditions
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.
Interventions
BEHAVIORALMBSR
Mindfulness-Based Stress Reduction
BEHAVIORALMBWC
Mindfulness-Based Well-Being Curriculum
BEHAVIORALMBCI
Mindfulness-Based Curriculum for Insomnia
DEVICEBSI
Brain Stimulation Intervention
Sponsors
National Health Research Institutes, Taiwan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in neural activation related to emotional processing, sensory processing, attention, and memory-related brain regions. | 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). |
| Changes in resting-state functional connectivity within and between brain networks | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | Statistically significant changes across 3 time points using Verbal fluency scores in categories of colors, animals, cities, and fruits. |
| 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). | 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. |
| 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). | Anxiety scale changes measured by the Hamilton anxiety rating scale (scores between 0 and 48) across 3 time points. |
| Changes in the loneliness 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 of the loneliness scale developed by the University of California, Los Angeles, across 3 time points |
| Changes in perceived stress | 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 |
| 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. | 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. |
| Changes in self-reported sleep outcomes assessed through sleepiness and sleep quality | 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 |
| Changes in self-reported intervention outcomes in terms of mindfulness, flourishing, and well-being | 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). |
| Dynamic patterns of objective sleep parameters assessed through smart watch monitoring | 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. |
| Dynamic patterns of objective cardiovascular parameters assessed through smart watch monitoring | 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. |
| Changes in the apathy 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 of the 18-item apathy evaluation scale (scores between 0 and 72) across 3 time points |
| 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). | 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). |
Countries
Taiwan
Contacts
Primary ContactAi-Ling Hsu, PhD.
Backup ContactChangwei W. Wu, PhD.
Outcome results
None listed