Modifiers and Mechanisms of Loneliness Interventions

NCT05812989 | Completed

• 3 other identifiers: STUDY00007800P30AG064103-Pilot7P30AG064103
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness

Outcome Measures

Primary Outcomes (5)

• Loneliness

  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).

  11 weeks

• High frequency heart rate variability (HF-HRV)

  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.

  11 weeks

• Dot probe task

  Difference in response times (in milliseconds) to dots appearing in the location of a previously shown negative versus the neutral face.

  11 weeks

• Affect (valence) from Self-Assessment Manikin

  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).

  11 weeks

• Stroop Task

  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.

  11 weeks

Secondary Outcomes (2)

• Flanker Task

  11 weeks

• Set-Shifting Task

  11 weeks

Study Arms (2)

Social Engage Coaching

ACTIVE COMPARATOR

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.

Behavioral: Social Engage Coaching

Social Engage Coaching with Connect for Caregivers

ACTIVE COMPARATOR

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.

Behavioral: Social Engage Coaching; Behavioral: Connect for Caregivers

Interventions

Social Engage Coaching BEHAVIORAL

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.

Social Engage Coaching; Social Engage Coaching with Connect for Caregivers

Connect for Caregivers BEHAVIORAL

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.

Also known as: Digitized prioritization of goals and action planning for social engagement.

Social Engage Coaching with Connect for Caregivers

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Caregivers

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Kathi L Heffner, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 14, 2023
• Study Start: October 18, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Timetable to release the data: the data and referenced resources from publications will be made available by the on-line publication date.
• Access Criteria: The investigators will make the data and associated documentation available to users only under a data-sharing agreement as suggested by the NIH that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. 4. De-identification of data from human subjects: A final complete database will be created to host all data which will be stripped of any identifiers and stored pursuant to UR Institutional Review Board protocols. Confidentiality for research subjects for qualitative data will be promoted by the use of an anonymization scheme and anonymizing the data as the qualitative files are created for the analysis (following guidelines developed by the Inter-university Consortium for Political and Social Research, 2012).

Locations

US (1)