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Search / Trial NCT05812989

Modifiers and Mechanisms of Loneliness Interventions

Launched by UNIVERSITY OF ROCHESTER · Mar 31, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring ways to help caregivers who feel lonely and stressed while caring for a loved one with Alzheimer's disease or similar conditions. The researchers want to understand how managing emotions can help caregivers respond better to social challenges and improve their feelings of loneliness. They will also test a new digital tool designed to help coaches provide better support to these caregivers.

To join the study, participants must be caregivers aged 50 or older who live close to someone with Alzheimer's or related dementia and have experienced significant stress or feelings of loneliness. Participants can expect to take part in sessions that focus on emotional support and receive guidance through the new digital tool. The goal is to see if these interventions can help reduce loneliness and improve the quality of life for both caregivers and their loved ones.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Caregiver (age 50 or older) for a community-dwelling loved one with Alzheimer's disease or related dementia (ADRD), living with (or in close proximity to) the person with ADRD.
  • Elevated caregiving distress: above population mean (\>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score \>= 5) on the Modified Caregiver Strain Index.
  • Social disconnection: UCLA Loneliness Scale: Short Form score of \> 5.
  • Exclusion Criteria:
  • Non-English speaking
  • Significant cognitive impairment
  • Major cardiovascular conditions that may interfere with reliable assessment of HRV (e.g., congestive heart failure, pacemaker, prior myocardial infarction).

About University Of Rochester

The University of Rochester is a leading academic institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Renowned for its commitment to excellence in education, research, and clinical practice, the university fosters a collaborative environment that integrates cutting-edge scientific inquiry with practical applications in healthcare. With a focus on diverse therapeutic areas, the University of Rochester aims to enhance treatment options and outcomes for patients while contributing to the broader scientific community through rigorous study design and ethical standards in clinical research.

Locations

Rochester, New York, United States

Patients applied

0 patients applied

Trial Officials

Kathi L Heffner, PhD

Principal Investigator

University of Rochester

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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