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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorNational Health Research Institutes, Taiwan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

124 Participants
are divided into 4 treatment groups
Group A: MBSRActive comparator 1 intervention
Group B: MBWCActive comparator 1 intervention
Group C: MBCIActive comparator 1 intervention
Group D: BSIOther 1 intervention

Trial outcomes

Primary outcomes

1

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).

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.
2

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).

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 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.

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.

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.
2

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).

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).
3

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.

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).
4

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.

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).

Other outcomes

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