Modifiers and Mechanisms of Loneliness Interventions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Loneliness
- Sponsor
- University of Rochester
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- High frequency heart rate variability (HF-HRV)
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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
Investigators
Kathi Heffner
Professor
University of Rochester
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).
Outcomes
Primary Outcomes
High frequency heart rate variability (HF-HRV)
Time Frame: 11 weeks
HF-HRV is derived by spectral analysis of the electrocardiograph (ECG) waveform collected during a rest period, and is a measure of parasympathetic control of the heart; Higher resting HF-HRV (absolute power of the high-frequency band (0.15-0.4 Hz) in ms-squared) reflects greater parasympathetic regulation of the heart.
Loneliness
Time Frame: 11 weeks
UCLA Loneliness Scale Version 3, which assesses self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness).
Affect (valence) from Self-Assessment Manikin
Time Frame: 11 weeks
Mean valence score during negatively valenced social pictures. The Self-Assessment Manikin is a non-verbal pictorial assessment technique that directly measures a person's affect in response to positive, negative, and neutrally valenced pictures. Affect valence is measured on a 9-point scale: 1 (very unpleasant) - 9 (very pleasant).
Stroop Task
Time Frame: 11 weeks
Difference in response time (ms) to judgments of semantic meaning (positive or negative) of spoken, socially-relevant words between congruent (e.g., negative social word-negative vocal tone) versus incongruent (e.g., positive social word-negative vocal tone) trials, indicating cognitive interference.
Dot probe task
Time Frame: 11 weeks
Difference in response times (in milliseconds) to dots appearing in the location of a previously shown negative versus the neutral face.
Secondary Outcomes
- Flanker Task(11 weeks)
- Set-Shifting Task(11 weeks)