Late-Life AdultsPredictNPINCT07186023
Effects of Mindfulness or Brain Stimulation Intervention for Late-life Adults in Taiwan Urban and Rural Areas
A study testing MBSR, MBWC and MBCI in people with Late-Life Adults and Late-Life Prodromal Depression, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Late-Life Adults, Late-Life Prodromal Depression, Late-Life Depression
- What is being tested?
- MBSR, MBWC and MBCI
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Aug 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Shuang Ho Biomedical Park, Taipei Medical University
New Taipei City, 235603
Changwei W. Wu, PhD., +886-2-66202589 ext. 10518, sleepbrain@tmu.edu.tw
- Not yet recruiting
National Center for Geriatrics and Welfare Research
Yunlin, 632007
Ai-Ling Hsu, PhD., +886-5-6327369 ext. 143, alhsu@nhri.edu.tw
About this study
Official title: Intervention Evaluation for Late-life Depression in Taiwan Urban and Rural Areas: Long-term Tracking and Prediction of Non-pharmaceutical Interventions by Smart AI Technologies
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.
- Conditions
- Late-Life Adults, Late-Life Prodromal Depression, Late-Life Depression, Mindfulness, Brain Stimulation Intervention
- Being tested
- MBSR, MBWC, MBCI, BSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Mindfulness-Based Stress Reduction
MBWCBehavioural
Mindfulness-Based Well-Being Curriculum
MBCIBehavioural
Mindfulness-Based Curriculum for Insomnia
BSIDevice
Brain Stimulation Intervention
| Study group | Role | What they receive |
|---|---|---|
| MBSR | Active comparator | Mindfulness-Based Stress Reduction Receives: Behavioral: MBSR |
| MBWC | Active comparator | Mindfulness-Based Well-Being Curriculum Receives: Behavioral: MBWC |
| MBCI | Active comparator | Mindfulness-Based Curriculum for Insomnia Receives: Behavioral: MBCI |
| BSI | Other | Brain Stimulation Intervention Receives: Device: BSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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 (12)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Aug 2025
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late-Life AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai-Ling Hsu, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186023
- Sponsor's protocol ID
- EC1140405
- Other IDs
- CG-114-GP-23
- Acronym
- PredictNPI
- Status last verified
- Sep 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Evaluation for Late-life Depression in Taiwan Urban and Rural Areas: Long-term Tracking and Prediction of Non-pharmaceutical Interventions by Smart AI Technologies
- ClinicalTrials.gov ID
- NCT07186023
- Acronym / sponsor ID
- PredictNPI / EC1140405
- Conditions
- Late-Life Adults, Late-Life Prodromal Depression, Late-Life Depression, Mindfulness, Brain Stimulation Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MBSR | Active comparator | Behavioral: MBSRMindfulness-Based Stress Reduction |
| MBWC | Active comparator | Behavioral: MBWCMindfulness-Based Well-Being Curriculum |
| MBCI | Active comparator | Behavioral: MBCIMindfulness-Based Curriculum for Insomnia |
| BSI | Other | Device: BSIBrain Stimulation Intervention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBSRMindfulness-Based Stress Reduction | Behavioural | MBSR |
| MBWCMindfulness-Based Well-Being Curriculum | Behavioural | MBWC |
| MBCIMindfulness-Based Curriculum for Insomnia | Behavioural | MBCI |
| BSIBrain Stimulation Intervention | Device | BSI |
Primary outcome
Changes in neural activation related to emotional processing, sensory processing, attention, and memory-related brain regions.
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.
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
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.
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).
12 secondary outcomes
Regional brain morphometric changes, assessed by quantitative analysis of gray matter volume, thickness, and density differences using high-resolution structural magnetic resonance imaging.
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.
Self-reported neuropsychological outcomes assessed through validated Wechsler Adult Intelligence Scale (WAIS).
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).
Scores of the total number of category-naming items correctly named within one minute for testing verbal fluency.
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).
Changes in the depression scale
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).
Changes in anxiety scale
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).
Changes in the loneliness scale
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).
Changes in perceived stress
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).
Changes in the apathy scale
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).
Changes in self-reported sleep outcomes assessed through sleepiness and sleep quality
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).
Changes in self-reported intervention outcomes in terms of mindfulness, flourishing, and well-being
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).
Dynamic patterns of objective sleep parameters assessed through smart watch monitoring
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Late-Life Adults
Not yet recruitingPhase 2
The BAARD Study : Evaluating a Computerized Approach to Treatment Selection in Older Adults With Treatment Resistant Depression.
Late Life Treatment Resistant Depression, Depression - Major Depressive Disorder
Not yet recruiting
A Mechanism Randomised Controlled Trial of a Three-Agent LLM-Augmented mHealth Intervention for Late-Life Loneliness in Older Adults
Loneliness, Social Isolation
RecruitingPhase 3
Lumateperone for Late-Life Depression
Treatment Resistant Depression (TRD), Late Life Depression (LLD)
Recruiting
Engage Coaching (R33 Phase)
Social Connection, Loneliness
Recruiting
Home-Based Brain Stimulation for Motoric Cognitive Risk Syndrome
Alzheimer Disease and Related Dementias, Cognition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR, MBWC and MBCI in people with Late-Life Adults and Late-Life Prodromal Depression, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ai-Ling Hsu, PhD. (+886-5-6327369 ext. 143, alhsu@nhri.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neural activation related to emotional processing, sensory processing, attention, and memory-related brain regions. (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.