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

Not Applicable

Recruiting

• Conditions: Late-Life Adults; Late-Life Prodromal Depression; Late-Life Depression; Mindfulness; Brain Stimulation Intervention

• Registration Number: NCT07186023
• Lead Sponsor: National Health Research Institutes, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-01
• Study First Submitted: 2025-08-14
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2028-05
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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
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
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.

Trial Locations

Locations (2)

Shuang Ho Biomedical Park, Taipei Medical University; 🇨🇳 New Taipei City, Taiwan

National Center for Geriatrics and Welfare Research; 🇨🇳 Yunlin, Taiwan