Loneliness
Conditions
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
Interventions
BEHAVIORALSocial 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.
BEHAVIORALConnect 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
University of Rochester
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness | 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). |
| High Frequency Heart Rate Variability (HF-HRV) | 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. |
| Dot Probe Task | 11 weeks | Difference in response times (in milliseconds) to dots appearing in the location of a previously shown negative versus the neutral face. Negative values indicate a shorter response time to negative versus neutral faces (interpreted as a greater attentional bias to negative versus neutral faces). |
| Affect (Valence) From Self-Assessment Manikin | 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 | 11 weeks | Difference in response time (in ms) to congruent versus incongruent trials, where congruent trials presented, for example, a positive social word spoken in a positive tone of voice whereas incongruent trials presented, for example, a positive social word spoken in a negative tone of voice. Negative values indicate longer response times to incongruent trials (interpreted as greater cognitive interference/distraction when trying to determine the semantic meaning (positive or negative) of a word when the vocal tone is inconsistent with the semantic meaning of the word. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flanker Task | 11 weeks | During the trials, a decision needs to be made about whether the orientation of a central stimulus is congruent or incongruent with a set of flanking arrows. Selective attention/cognitive inhibition is indicated by difference between response time (millisecond) on the congruent and incongruent conditions. |
| Set-Shifting Task | 11 weeks | During each trial, the participant is required to match a stimulus on the top of the screen to one of two stimuli in the lower corners of the screen. In task-homogeneous blocks, the examinee performs either Task A (e.g., classifying shapes) or Task B (e.g., classifying colors). In task-heterogeneous blocks, the examinee alternates between the two tasks pseudo-randomly. Cognitive flexibility (or capacity for task switching) is derived as the difference in response time (milleseconds) between homogeneous and heterogenous blocks. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKathi L Heffner, PhD
University of Rochester
Baseline characteristics
| Characteristic | — |
|---|---|
| Affect (valence) from Self-Assessment Manikin | 5.32 total score STANDARD_DEVIATION 1.6 |
| Age, Continuous | 69.08 Years |
| Dot Probe Task | -0.51 Milliseconds STANDARD_DEVIATION 37.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Flanker Task | 8.35 milliseconds STANDARD_DEVIATION 0.55 |
| High frequency heart rate variability (HF-HRV) | 5.67 ms-squared STANDARD_DEVIATION 1.73 |
| Loneliness | 49.11 Total score STANDARD_DEVIATION 11.88 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Set Shifting Task | 8.00 milliseconds STANDARD_DEVIATION 0.75 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 5 Participants |
| Stroop Task | -107.08 Milliseconds STANDARD_DEVIATION 217.41 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 0 / 27 | 1 / 25 |
Outcome results
None listed