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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

Dynamo Trial 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.Check my eligibility

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.See study design

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.

Dynamo Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the Warwick Edinburgh Mental Well Being Scale WEMWBS

Secondary outcome measures

Change in Patient Health Questionnaire (PHQ-9)

Change in Psychological Stress Measure (PSM-9)

Change in the 20-item UCLA loneliness scale

+1 more

Dynamo 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,238,533 Total Patients Enrolled

2 Trials studying Loneliness

544 Patients Enrolled for Loneliness

National Institute on Aging (NIA)NIH

1,676 Previous Clinical Trials

28,021,459 Total Patients Enrolled

13 Trials studying Loneliness

3,106 Patients Enrolled for Loneliness

Lorenzo Pasquini, PhDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Active placebo Clinical Trial Eligibility Overview. Trial Name: NCT05645835 — N/A

Loneliness Research Study Groups: intervention, waitlist control

Loneliness Clinical Trial 2023: Active placebo Highlights & Side Effects. Trial Name: NCT05645835 — N/A

Active placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05645835 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the study accepting participants aged seventy-five and over?

"To be eligible, participants must fall within the 65-85 age bracket. This medical trial has already enrolled 5 minors and 80 seniors."

Answered by AI

Can I become a participant in this research endeavor?

"This research is seeking 40 elderly individuals who suffer from loneliness and are aged between 65 to 85. In order to qualify, applicants must meet the following guidelines: be at least 65 years of age; possess conversational capacity in English; lack any exposure or familiarity with meditative practices (no more than one hour per month spent meditating); not have any MRI-related contraindications; and be cognitively sound (without dementia, stroke history, developmental disorders, or systemic diseases that may influence mental acuity)."

Answered by AI

Are there any available opportunities to participate in this research?

"The records on clinicaltrials.gov demonstrate that this particular trial is no longer recruiting participants; it was first posted on February 1st 2023 and the last update occurred December 15th 2022. Fortunately, there are 86 other trials currently enrolling patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults

2023. "Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05645835.