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Digital Intervention for Loneliness in Aging Adults (Dynamo Trial)

N/A

Recruiting

Led By Lorenzo Pasquini, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in stress from baseline to directly after completing the intervention (6 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effect of an app-based intervention on emotional health in older adults who feel lonely. Brain scans & body measurements used to measure impact.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since this is a non-drug intervention involving meditation practices delivered through an app, side effects may include discomfort during practice or increased awareness of emotions but typically do not involve physical side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in stress from baseline to directly after completing the intervention (6 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in stress from baseline to directly after completing the intervention (6 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in stress from baseline to directly after completing the intervention (6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Warwick Edinburgh Mental Well Being Scale WEMWBS

Secondary study objectives

Change in Patient Health Questionnaire (PHQ-9)

Change in Psychological Stress Measure (PSM-9)

Change in the 20-item UCLA loneliness scale

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment 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: 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

intervention

2022

N/A

~1200

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