Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

Not Applicable

Recruiting

• Conditions: Loneliness; Emotions; Older Adults; fMRI; EEG; Digital Intervention; Meditation
• Interventions: Behavioral: intervention; Behavioral: waitlist control

• Registration Number: NCT05645835
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-12
• Study Start: 2023-10-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12-28
• Study Completion: 2025-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in the Warwick Edinburgh Mental Well Being Scale WEMWBS	Change in well-being from baseline to directly after completing the intervention (6 weeks)	WEMWBS ranges from 14-70, with higher values indicating higher mental well-being

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States