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Modifiers and Mechanisms of Loneliness Interventions

NCT05812989 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-07-09

No results posted yet for this study

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.

Conditions

  • Loneliness

Interventions

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Rochester

    lead OTHER

Principal Investigators

  • Kathi L Heffner, PhD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05812989 on ClinicalTrials.gov