Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

NCT ID: NCT05645835

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-13

Study Completion Date

2026-07-01

Brief Summary

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Assess the impact of a remote, app-delivered digital meditation intervention on emotional well-being of lonely older adults. Neuroimaging, electrophysiological (EEG), and autonomic physiology will be used to assess the neural correlates of the intervention. EEG and autonomic physiology will be collected while participants watch 30 min of an awe-inspiring movie. fMRI and autonomic physiology will be collected in the context of a social exploration/exploitation task.

Detailed Description

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Conditions

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Loneliness Older Adults fMRI Emotions EEG Digital Intervention Meditation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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intervention

Participants will engage with the digital meditation app delivering the intervention 15 min a day, five days, a week for 6 weeks.

Group Type EXPERIMENTAL

intervention

Intervention Type BEHAVIORAL

the digital meditation app will be installed on participants iPad or android. Lonely older adults will use the app five days a week for six weeks total. Neuroimaging will be performed before and after the intervention.

waitlist control

Participants will be randomized to a waitlist group for six weeks. The waitlist control group will then be able to use the meditation app for six weeks as the primary intervention group

Group Type ACTIVE_COMPARATOR

waitlist control

Intervention Type BEHAVIORAL

Participants in the waitlist group will have to wait six weeks after being screened before being able to use the meditation app after the assessment of primary and secondary endpoints

Baseline physiology

A subset of participants will not participate in the intervention. Only baseline fMRI and EEG data will be collected in these participants.

Group Type OTHER

No Interventions

Intervention Type OTHER

No intervention. Only baseline fMRI and EEG assessment.

Interventions

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intervention

the digital meditation app will be installed on participants iPad or android. Lonely older adults will use the app five days a week for six weeks total. Neuroimaging will be performed before and after the intervention.

Intervention Type BEHAVIORAL

waitlist control

Participants in the waitlist group will have to wait six weeks after being screened before being able to use the meditation app after the assessment of primary and secondary endpoints

Intervention Type BEHAVIORAL

No Interventions

No intervention. Only baseline fMRI and EEG assessment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 60 years of age or older
* English language fluency
* Naive to meditation practices (not actively meditating more than one hour per month and/or meditation practice for less than a year in their entire life-time)
* No MRI contra-indications
* Cognitively healthy (no diagnosis of dementia, stroke, developmental disorders, or major systemic diseases that may impact cognitive function)

Exclusion Criteria

* Below 60 years of age
* Not fluent in English
* Active meditator (meditating more than one hour per month and/or meditation practice for more than a year in their entire life-time).
* Presence of a severe psychiatric (e.g. schizophrenia, bipolar disorder, PTSD), neurological (epilepsy, traumatic brain injury, dementia, multiple sclerosis), or developmental disorder (e.g. autism)
* Systemic disease (e.g. major recent surgeries, cancer)
* Claustrophobia
* Contraindications for MR safety (e.g. metal in body, cochlea implants)
Minimum Eligible Age

60 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lorenzo Pasquini, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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R00AG065457

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K99AG065457

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-37461

Identifier Type: -

Identifier Source: org_study_id