Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

Study Overview
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Brief Summary
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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.

Official Title
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Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

Conditions
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fMRI, EEG, Digital Intervention, Meditation, Loneliness, Older Adults, Emotions

Intervention / Treatment
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* Behavioral: intervention
* Behavioral: waitlist control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>Participants will engage with the digital meditation app delivering the intervention 15 min a day, five days, a week for 6 weeks. | Behavioral: intervention<br>* 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.<br>|
| Active Comparator: waitlist control<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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) |