Modifiers and Mechanisms of Loneliness Interventions

University of Rochester

Status: Completed

Conditions: Loneliness

Treatments: Behavioral: Connect for Caregivers; Behavioral: Social Engage Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05812989

P30AG064103 (U.S. NIH Grant/Contract)

STUDY00007800

P30AG064103-Pilot7 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 53 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Social Engage Coaching

Active Comparator group

Description:

Social Engage Coaching involves psychoeducation on the importance of social connections for health as well as structured goal setting and problem solving for increasing social connectedness.

Treatment:

Behavioral: Social Engage Coaching

Social Engage Coaching with Connect for Caregivers

Active Comparator group

Description:

Social Engage Coaching involves psychoeducation on the importance of social connections for health as well as structured goal setting and problem solving, guided by use of a digitized prioritization tool, for increasing social connectedness.

Treatment:

Behavioral: Social Engage Coaching

Behavioral: Connect for Caregivers