NCT05812989

Modifiers and Mechanisms of Loneliness Interventions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Loneliness

Interventions

Type	Name	Description
BEHAVIORAL	Social Engage Coaching	Participants will complete up to 8 weekly individual Social Engage psychotherapy sessions. Participants will be allotted up to 3 months to complete all sessions, a time-frame that allows for two weeks without meeting to address life stressors such as illnesses that may pop up. All sessions are provided via phone or videocall (Zoom). The first and last session are longer - up to 60 minutes if needed. Middle sessions are shorter (20-45 minutes). Engage is a stepped care psychotherapy in that the simplest strategy is taught first-action planning (a derivative of problem solving therapy)-and "barrier strategies" are added only if needed. Action plans are designed to address loneliness and social isolation in the context of caregiving demands.
BEHAVIORAL	Connect for Caregivers	Participants will complete an individual session with a coach who will use a digitized prioritization tool to help identify goals and an action plan for social connectedness.

Timeline

• Start date: 2023-10-18
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-04-14
• Last updated: 2025-07-09

Locations

1 site across 1 country: United States