Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

NCT05645835 | Active Not Recruiting

• 3 other identifiers: 22-37461R00AG065457K99AG065457
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Loneliness; Older Adults; fMRI; Emotions; EEG; Digital Intervention; Meditation

Outcome Measures

Primary Outcomes (1)

• Change in the WHO-5 Well-Being Index

  WHO-5 ranges from 0-25, with higher values indicating higher well-being

  Change in well-being from baseline to directly after completing the intervention (6 weeks)

Secondary Outcomes (4)

• Change in the 20-item UCLA loneliness scale

  Change in loneliness from baseline to directly after completing the intervention (6 weeks)

• Change in the General Anxiety Disorder-7 (GAD-7)

  Change in anxiety from baseline to directly after completing the intervention (6 weeks)

• Change in Psychological Stress Measure (PSM-9)

  Change in stress from baseline to directly after completing the intervention (6 weeks)

• Change in Patient Health Questionnaire (PHQ-9)

  Change in depression from baseline to directly after completing the intervention (6 weeks)

Study Arms (3)

intervention

EXPERIMENTAL

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

Behavioral: intervention

waitlist control

ACTIVE COMPARATOR

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

Behavioral: waitlist control

Baseline physiology

OTHER

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

Other: No Interventions

Interventions

intervention 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.

intervention

waitlist control 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

waitlist control

No Interventions OTHER

No intervention. Only baseline fMRI and EEG assessment.

Baseline physiology

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Lorenzo Pasquini, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 12, 2022
• Study Start: October 13, 2023
• Primary Completion: December 28, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)