Modifiers and Mechanisms of Loneliness Interventions
NCT05812989, Not applicable, Completed, University of Rochester
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Modifiers and Mechanisms of Loneliness Interventions | ClinicalTrials.gov |
| NCT number | NCT05812989 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 52 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Rochester | ClinicalTrials.gov |
| Conditions | Loneliness | ClinicalTrials.gov |
| Interventions | Social Engage Coaching, Connect for Caregivers | ClinicalTrials.gov |
| First posted | 2023-04-14 | ClinicalTrials.gov |
| Last updated | 2026-08-12 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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). | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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). | ClinicalTrials.gov |
| Primary | 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). | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30AG064103 | Rochester Roybal Center for Social Ties and Aging Research | HEFFNER, KATHI L; VAN ORDEN, KIMBERLY ALLISON | UNIVERSITY OF ROCHESTER | NATIONAL INSTITUTE ON AGING | 2019 to 2023 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Dot-Probe Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Eriksen Flanker Task | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)