Clinical trial NCT05645835: Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults
Official title: Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Older Adults
fMRI
Emotions
EEG
Digital Intervention
Meditation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-12-12
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in the Warwick Edinburgh Mental Well Being Scale WEMWBS
timeFrame: Change in well-being from baseline to directly after completing the intervention (6 weeks)
Secondary outcomes:
measure: Change in the 20-item UCLA loneliness scale
timeFrame: Change in loneliness from baseline to directly after completing the intervention (6 weeks)
measure: Change in the General Anxiety Disorder-7 (GAD-7)
timeFrame: Change in anxiety from baseline to directly after completing the intervention (6 weeks)
measure: Change in Psychological Stress Measure (PSM-9)
timeFrame: Change in stress from baseline to directly after completing the intervention (6 weeks)
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: Change in depression from baseline to directly after completing the intervention (6 weeks)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Lorenzo Pasquini, PhD
role: PRINCIPAL_INVESTIGATOR
References: