Recruiting
Effects of Mindfulness or Brain Stimulation Intervention for Late-life Adults in Taiwan Urban and Rural Areas
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.
ClinicalTrials.gov IDNCT07186023
PhaseNA
Enrollment124
SponsorNational Health Research Institutes, Taiwan
Age55 Years
SexALL
Conditions studied
Late-Life Adults, Late-Life Prodromal Depression, Late-Life Depression, Mindfulness, Brain Stimulation Intervention
About this study
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 outcomes
- 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.)
- 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.)
Eligibility information
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.
Study locations
- Shuang Ho Biomedical Park, Taipei Medical University, New Taipei City, 235603 Taiwan
- National Center for Geriatrics and Welfare Research, Yunlin, 632007 Taiwan
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-02.