LonelinessDynamoNCT05645835
Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults
A study testing intervention in people with Loneliness and Older Adults, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Older Adults, fMRI
- What is being tested?
- intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2023to 1 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94158
About this study
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.
- Conditions
- Loneliness, Older Adults, fMRI, Emotions, EEG, Digital Intervention
- Being tested
- intervention, waitlist control, No Interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventionBehavioural
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 controlBehavioural
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
No InterventionsOther
No intervention. Only baseline fMRI and EEG assessment.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Participants will engage with the digital meditation app delivering the intervention 15 min a day, five days, a week for 6 weeks. Receives: Behavioral: intervention |
| waitlist control | Active comparator | 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 Receives: Behavioral: waitlist control |
| Baseline physiology | Other | A subset of participants will not participate in the intervention. Only baseline fMRI and EEG data will be collected in these participants. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the WHO-5 Well-Being Index
WHO-5 ranges from 0-25, with higher values indicating higher well-being
Measured: Change in well-being from baseline to directly after completing the intervention (6 weeks)
Secondary outcomes (4)
Change in the 20-item UCLA loneliness scale
This scale ranges from 20-80, with higher values indicating higher loneliness
Measured: 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
Measured: 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
Measured: 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
Measured: Change in depression from baseline to directly after completing the intervention (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start13 Oct 2023
- Primary completion8 Jan 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Pasquini, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645835
- Sponsor's protocol ID
- 22-37461
- Other IDs
- R00AG065457, K99AG065457
- Acronym
- Dynamo
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No