Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults (Dynamo)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Older Adults; Emotions; Loneliness; Meditation; fMRI; EEG; Digital Intervention
• Intervention / Treatment: Behavioral: intervention; Behavioral: waitlist control; Other: No Interventions

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; Participants will engage with the digital meditation app delivering the intervention 15 min a day, five days, a week for 6 weeks.	Behavioral: 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.
Active Comparator: 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	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
Other: Baseline physiology; 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; No intervention. Only baseline fMRI and EEG assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the 20-item UCLA loneliness scale	This scale ranges from 20-80, with higher values indicating higher loneliness	Change in loneliness from baseline to directly after completing the intervention (6 weeks)
Change in the General Anxiety Disorder-7 (GAD-7)	This scale ranges from 0-21, with higher values indicating higher anxiety	Change in anxiety from baseline to directly after completing the intervention (6 weeks)
Change in Psychological Stress Measure (PSM-9)	This scale ranges from 9-72, with higher values indicating higher stress	Change in stress from baseline to directly after completing the intervention (6 weeks)
Change in Patient Health Questionnaire (PHQ-9)	This scale ranges from 0-27, with higher values indicating higher depression	Change in depression from baseline to directly after completing the intervention (6 weeks)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Lorenzo Pasquini, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): December 28, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: 22-37461; R00AG065457 (U.S. NIH Grant/Contract); K99AG065457 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No