75 Participants Needed

Digital Intervention for Loneliness in Aging Adults

(Dynamo Trial)

LP
Overseen ByLorenzo Pasquini, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for reducing loneliness in aging adults?

Research shows that mindfulness training, which is part of the digital meditation intervention, can reduce loneliness by 22% and increase social contact, suggesting that similar digital interventions may help aging adults feel less lonely and more socially connected.12345

Is the digital intervention for loneliness in aging adults safe?

Research on mindfulness meditation interventions, including digital formats, shows no reported adverse events or side effects, indicating they are generally safe for humans.12678

How is the Digital Meditation Intervention treatment different from other treatments for loneliness in older adults?

The Digital Meditation Intervention is unique because it uses a remote app to deliver mindfulness meditation training, which is a novel approach compared to traditional in-person therapies or technology-based interventions like video calls or computer training. This method focuses on enhancing mental well-being through meditation, potentially offering a more accessible and flexible option for older adults.39101112

Research Team

LP

Lorenzo Pasquini, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for English-speaking older adults who are 65 or above, have little to no experience with meditation, and are cognitively healthy without major systemic diseases. They must not be active meditators, taking psychotropic drugs, or have severe psychiatric conditions. Also excluded are those with MRI contraindications like metal implants.

Inclusion Criteria

I am 60 years old or older.
English language fluency
I do not have any cognitive health issues like dementia or stroke.
See 2 more

Exclusion Criteria

Contraindications for MR safety (e.g. metal in body, cochlear implants)
I am younger than 60 years old.
I am not fluent in English.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the digital meditation app for 15 minutes a day, five days a week for 6 weeks

6 weeks
Remote engagement with app

Waitlist Control

Participants in the waitlist control group do not receive the intervention for the first 6 weeks

6 weeks

Follow-up

Participants are monitored for changes in emotional well-being, loneliness, anxiety, stress, and depression after completing the intervention

4 weeks

Treatment Details

Interventions

  • Active placebo
  • Intervention
Trial OverviewThe study tests a digital meditation app's effect on the emotional well-being of lonely aging adults using neuroimaging and autonomic physiology to see how their brains respond. Participants will either be placed in a waitlist control group or receive the intervention.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: interventionExperimental Treatment1 Intervention
Participants will engage with the digital meditation app delivering the intervention 15 min a day, five days, a week for 6 weeks.
Group II: Baseline physiologyExperimental Treatment1 Intervention
A subset of participants will not participate in the intervention. Only baseline fMRI and EEG data will be collected in these participants.
Group III: waitlist controlActive Control1 Intervention
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

A customized meditation program significantly reduced loneliness and improved wellbeing, life satisfaction, and contentment among 166 retired South Asian older adults over a 2-year period, with very high effect sizes (Cohen's d range = 2.43-8.78).
Regular home practice of meditation was identified as the strongest predictor of positive outcomes, explaining 17% of the variation in results, highlighting the importance of consistent engagement in the program.
Meditation program mitigates loneliness and promotes wellbeing, life satisfaction and contentment among retired older adults: a two-year follow-up study in four South Asian cities.Pandya, SP.[2021]
A smartphone-based mindfulness intervention that included both monitoring and acceptance skills significantly reduced loneliness by 22% and increased daily social interactions among 153 participants.
The study demonstrated that acceptance skills are crucial for improving social relationships, as removing these skills from the intervention eliminated the benefits of reduced loneliness and increased social contact.
Mindfulness training reduces loneliness and increases social contact in a randomized controlled trial.Lindsay, EK., Young, S., Brown, KW., et al.[2020]
The ALONE scale is a reliable and valid tool for screening severe loneliness in older adults, showing a strong correlation with the established UCLA-20 Loneliness Questionnaire in a study of 199 ambulatory clinic participants.
With a test-retest reliability score of 0.89, the ALONE scale is easy to administer in clinical settings, making it a practical option for healthcare providers to identify loneliness among older adults.
Validation of the ALONE Scale: A Clinical Measure of Loneliness.Deol, ES., Yamashita, K., Elliott, S., et al.[2022]

References

Meditation program mitigates loneliness and promotes wellbeing, life satisfaction and contentment among retired older adults: a two-year follow-up study in four South Asian cities. [2021]
Mindfulness training reduces loneliness and increases social contact in a randomized controlled trial. [2020]
Validation of the ALONE Scale: A Clinical Measure of Loneliness. [2022]
Development and psychometric evaluation of the loneliness inventory for older adults (Lonely): A mixed-methods study. [2022]
Predicting stability and change in loneliness in later life. [2019]
One-on-one Mindfulness Meditation Trainings in a Research Setting. [2021]
Online Short-Term Mindfulness-Based Intervention During COVID-19 Quarantine in Italy: Effects on Wellbeing, Stress, and Anxiety. [2022]
Can Mindfulness Help to Alleviate Loneliness? A Systematic Review and Meta-Analysis. [2021]
A Digital Gaming Intervention to Strengthen the Social Networks of Older Dutch Adults: Mixed Methods Process Evaluation of a Digitally Conducted Randomized Controlled Trial. [2023]
The Effectiveness of Technology-Based Interventions for Reducing Loneliness in Older Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
In-Home Technology Training Among Socially Isolated Older Adults: Findings From the Tech Allies Program. [2022]
Understanding the psychological experiences of loneliness in later life: qualitative protocol to inform technology development. [2023]