Official Title: Modifiers and Mechanisms of Loneliness Interventions
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A specific aim of this research is to identify the role of emotion regulation in response to social threat in caregivers response to a behavioral coaching intervention for loneliness A second aim of the study is to determine the benefit of a digitized social engagement prioritization tool for improving coaches intervention fidelity and caregiver outcomes This study is funded through the Pilot Award Program of the Rochester Roybal Center for Social Ties Aging Research a UR Center funded by the National Institute on Aging by grant P30AG064103
Detailed Description: The objective of this Stage III mechanistic study is to help identify additional modifiable targets and scalable approaches to support further development of highly effective mechanistic-informed approaches to reducing loneliness and improving social connectedness in caregivers This study is a Stage III 19-month 2 groups x 2 assessment timepoints randomized clinical trial RCT aimed at identifying whether lonely caregivers capacity is associated with the degree to which loneliness is reduced in response to social engagement intervention S-ENG Further the study will address whether a digitized social engagement prioritization tool C4C used in the first session of S-ENG can improve intervention fidelity and
Study Oversight
Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID
Type
Domain
Link
P30AG064103-Pilot7
OTHER_GRANT
None
None
P30AG064103
NIH
Rochester Roybal Center for Social Ties Aging Research