Clinical trial NCT05812989: Modifiers and Mechanisms of Loneliness Interventions
Official title: Modifiers and Mechanisms of Loneliness Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Loneliness
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-04-14
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Primary outcomes:
measure: Loneliness
timeFrame: 11 weeks
measure: High frequency heart rate variability (HF-HRV)
timeFrame: 11 weeks
measure: Dot probe task
timeFrame: 11 weeks
measure: Affect (valence) from Self-Assessment Manikin
timeFrame: 11 weeks
measure: Stroop Task
timeFrame: 11 weeks
Secondary outcomes:
measure: Flanker Task
timeFrame: 11 weeks
measure: Set-Shifting Task
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kathi L Heffner, PhD
role: PRINCIPAL_INVESTIGATOR
References: