Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

Loneliness Clinical Trial

— Dynamo  

Official title:

Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645835
• Other study ID #: 22-37461
• Secondary ID: R00AG065457K99AG
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: December 28, 2025

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: Lorenzo Pasquini, PhD
• Phone: (415) 476-1000
• Email: lorenzo.pasquini[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the impact of a remote, app-delivered digital meditation intervention on emotional well-being of lonely older adults. Neuroimaging and autonomic physiology will be used to assess the neural correlates of the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 28, 2025
• Est. primary completion date: December 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• EEG
• Emotions
• fMRI
• Loneliness
• Meditation
• Older Adults

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Warwick Edinburgh Mental Well Being Scale WEMWBS	WEMWBS ranges from 14-70, with higher values indicating higher mental well-being	Change in well-being from baseline to directly after completing the intervention (6 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)