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

National Health Research Institutes, Taiwan

Status: Enrolling

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

Treatments: Behavioral: MBSR; Device: BSI; Behavioral: MBWC; Behavioral: MBCI

Study type: Interventional

Funder types: Other

Identifiers

NCT07186023

CG-114-GP-23 (Other Grant/Funding Number)

EC1140405

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 4 patient groups

MBSR

Active Comparator group

Description:

Mindfulness-Based Stress Reduction

Treatment:

Behavioral: MBSR

MBWC

Active Comparator group

Description:

Mindfulness-Based Well-Being Curriculum

Treatment:

Behavioral: MBWC

MBCI

Active Comparator group

Description:

Mindfulness-Based Curriculum for Insomnia

Treatment:

Behavioral: MBCI

BSI

Other group

Description:

Brain Stimulation Intervention

Treatment:

Device: BSI