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| ID | Type | Description | Link |
|---|---|---|---|
| CG-114-GP-23 | Other Grant/Funding Number | National Health Research Institutes |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBSR | Active Comparator | Mindfulness-Based Stress Reduction |
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| MBWC | Active Comparator | Mindfulness-Based Well-Being Curriculum |
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| MBCI | Active Comparator | Mindfulness-Based Curriculum for Insomnia |
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| BSI | Other | Brain Stimulation Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBSR | Behavioral | Mindfulness-Based Stress Reduction |
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| MBWC |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Regional brain morphometric changes, assessed by quantitative analysis of gray matter volume, thickness, and density differences using high-resolution structural magnetic resonance imaging. | 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. |
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Inclusion Criteria for individuals participating in mindfulness-based Interventions:
Exclusion Criteria for individuals participating in mindfulness-based Interventions:
Inclusion Criteria for individuals participating in brain stimulation Intervention:
Exclusion Criteria for individuals participating in brain stimulation Intervention:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ai-Ling Hsu, PhD. | Contact | +886-5-6327369 | 143 | alhsu@nhri.edu.tw |
| Changwei W. Wu, PhD. | Contact | +886-2-66202589 | 10518 | sleepbrain@tmu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuang Ho Biomedical Park, Taipei Medical University | Recruiting | New Taipei City | 235603 | Taiwan |
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| Behavioral |
Mindfulness-Based Well-Being Curriculum |
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| MBCI | Behavioral | Mindfulness-Based Curriculum for Insomnia |
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| BSI | Device | Brain Stimulation Intervention |
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| 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). | 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). | 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. | Statistically significant changes across 3 time points using Verbal fluency scores in categories of colors, animals, cities, and fruits. | 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 | 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. | 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 | Anxiety scale changes measured by the Hamilton anxiety rating scale (scores between 0 and 48) across 3 time points. | 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 | Changes of the loneliness scale developed by the University of California, Los Angeles, across 3 time points | 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 | Changes of the 14-item perceived stress scale (scores between 0 and 56) across 3 time points | 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 | Changes of the 18-item apathy evaluation scale (scores between 0 and 72) across 3 time points | 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 | 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 | 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 | 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). | 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 | 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. | 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 | 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. | 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). |
| National Center for Geriatrics and Welfare Research | Not yet recruiting | Yunlin | 632007 | Taiwan |
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