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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Active, not recruiting

Conditions

Meditation
EEG
fMRI
Older Adults
Loneliness
Digital Intervention
Emotions

Treatments

Behavioral: intervention
Other: No Interventions
Behavioral: waitlist control

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05645835
22-37461
R00AG065457 (U.S. NIH Grant/Contract)
K99AG065457 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

60 to 120 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

intervention
Experimental group
Description:
Participants will engage with the digital meditation app delivering the intervention 15 min a day, five days, a week for 6 weeks.
Treatment:
Behavioral: intervention
waitlist control
Active Comparator group
Description:
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
Treatment:
Behavioral: waitlist control
Baseline physiology
Other group
Description:
A subset of participants will not participate in the intervention. Only baseline fMRI and EEG data will be collected in these participants.
Treatment:
Other: No Interventions

Trial contacts and locations

1

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Central trial contact

Lorenzo Pasquini, PhD

Data sourced from clinicaltrials.gov

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