Heart Rate VariabilityNCT05560893
The Heart of the Community Study
A study testing Relational Savoring Intervention in people with Heart Rate Variability, run by University of California, Irvine at 1 site in United States.
Trial summary
Community service providers (CSPs), such as promotores and other community health staff, play an essential role in preserving health and treating disease in underserved Hispanic/Latinx (HL) communities with disproportionately high rates of cardiometabolic (CM) disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability
- What is being tested?
- Relational Savoring Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for participants includes being an employee at one of the community health agencies serving low income HL families that we are partnered with (Latino Health Access in Santa Ana or Ser Familia in Atlanta).
Who cannot join
- Not being an employee at one of the community health agencies involved in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: El Corazon de La Comunidad Study - The Purpose of This Research Study is to Develop, Implement, and Evaluate a Community-based Approach to Bolstering the Health and Efficacy of Community Service Providers
Community service providers (CSPs), such as promotores and other community health staff, play an essential role in preserving health and treating disease in underserved Hispanic/Latinx (HL) communities with disproportionately high rates of cardiometabolic (CM) disease. Although effective programs have been developed that deploy CSPs to reduce CM disease risk in the community, to our knowledge no interventions have sought to reduce CM risk among CSPs themselves. However, CSPs are also at high risk for adverse CM outcomes, as they have the same high-risk demographics as the communities they serve and they work in high-stress, frontline jobs. Reducing CM risk among HL CSPs is crucial to promote health at both the individual and community levels; that is, preventive interventions delivered to CSPs may not only promote the health of the individual CSPs who receive the intervention but also may bolster CSPs to more effectively deliver programming that protects CM health community-wide. The proposed study employs relational savoring (RS), a brief intervention rooted in positive psychology and attachment, which has previously been shown to promote psychosocial well-being and which is particularly efficacious in HL populations. Emerging research supports that RS may also promote more optimal cardiovascular regulation and health behavior. Therefore, the investigators deliver RS to CSPs in order to identify CM health protective effects for both CSPs and the high-risk communities they serve.
Aims and Hypotheses:
Aim 1: Examine effects of RS on CSPs' CM risk factors and outcomes. Hypotheses: RS (compared to wait-list control) will be associated with lower CM risk, as indexed by higher mean HRV, both during a stressor and at rest (H1A). RS will also be associated with a more favorable CM health behavior profile, indexed by higher quality sleep, more exercise, and healthier diet (H1B). Aim 2: Examine effects of RS on CSPs' delivery of CM health programming to the community. Hypotheses: RS will be associated both with reduced threats to CSPs leaving the workforce, including higher satisfaction with work, greater agency, and lower burnout (H2A), and with a higher number of community members reached for CM health programming, as indexed by number of days CSP worked, number of health-related events offered by CSPs, community attendance at events, and retention of community members across multi-day programs (H2B).
Read the detailed description
Although HL Americans face higher CM risk than do non-Hispanic white Americans, they have markedly lower access to healthcare. CSPs, including promotores and frontline community health staff, are community members who serve as hubs of health services provision within low-income HL communities and are critical conduits of the information, support, and care needed to prevent and manage CM disease. Yet as members of the low-income HL communities they serve, CSPs are at risk for the same negative health outcomes as those they support. This risk is amplified by the enormous stress the COVID-19 pandemic has wrought on frontline healthcare workers, such as CSPs. Employment in frontline health work during COVID-19 has been associated with psychological distress, including anxiety, depression, insomnia, and burnout; major and chronic stress, and work stress in particular, in turn, is associated with higher rates of CM disease. Therefore, CPSs are doubly at risk, from both their demographics and their occupation. However, to our knowledge, no intervention programs have been designed to protect CM health among CSPs specifically.
When CSP's health and wellbeing is at risk, the CM health of the larger community hangs in the balance. CSP-led community interventions, such as diabetes and obesity prevention programs, have proven effective, affordable, and well-received in reducing CM risk factors in the community, such as A1c, blood pressure, LDL cholesterol, triglycerides, insulin, sedentary behavior, and overweight. However, the COVID- 19 pandemic has endangered CSPs' abilities to deliver these important programs by placing tremendous demand on CSPs, contributing to professional burnout. Fortifying CSPs to effectively deliver crucial health programming despite enormous contextual burdens may have cascading effects on the CM health of HL communities. In strengthening CSPs that serve low income HL communities, not only does the intervention reduce the risk experienced by the CSPs themselves, but the investigation also stand to strengthen the entire HL community, by investing in the people who disseminate interventions to the community. Thus, brief interventions are needed for CSPs to protect health and to reduce risk factors that may interrupt service delivery to the community, such as burn-out in the face of environmental stress, in order to protect CM health for both CSPs and the communities they serve. Moreover, our community partner, Latino Health Access (LHA), identified programs to support the health and wellbeing of CSPs using a "mind-body approach" as a top priority for their agency.
Relational savoring (RS) is a brief intervention grounded in positive psychology and attachment theory that involves reflecting deeply on a positive emotional experience occurring with another person. The central premise underlying RS is that focusing deeply on moments of positive connection helps to augment the positive emotion and meaning the participants derive from positive interpersonal experiences, in order to enhance fulfillment and satisfaction, resolve distress, and increase one's sense of psychological agency. RS involves recalling a time when one supported or comforted another person and doing so brought deep positive emotion (joy, satisfaction, love, or peace); these moments of connection in service of another are common among the CSPs who work for our community agency, but may go unnoticed in the face of the urgent stressors the COVID-19 pandemic has brought about. Prolonging and enhancing attention to these moments has the potential to both help CSPs restore regulation in the face of stress and to motivate CSPs to continue engaging in meaningful work that serves their communities. RS is a one-on-one intervention that can be led by interveners with minimal training (e.g., undergraduates, promotores) to a high level of fidelity and delivered in brief sessions (30 minutes). Interveners help participants identify a connected memory, then lead participants through a 5-step reflection process that involves deeply focusing on different aspects of the memory. To date, RS has been tested among parents, long-distance partners, military partners during a deployment, older adults, and people in residential psychiatric treatment. RS is particularly effective among HL populations, perhaps because of its congruence with HL values such as simpatía and familismo. RS shows tremendous promise in improving psychological indicators of well-being, including more optimal emotional state, greater relationship satisfaction, interactional quality, and greater psychological agency. Early data support that RS may also shape mechanisms underlying physical health, as RS enhances both health behavior (greater adherence to safety measures during COVID-19) and cardiovascular regulation (lower heart rate while completing RS than while savoring an individual experience). However, RS has yet to be linked with CM health behaviors, such as physical activity, or with CM disease markers, such as heart rate variability (HRV), a non-invasive measure of parasympathetic activity which is linked with CM morbidity and mortality.
Utility of targeting CM disease risk markers through psychosocial interventions:
HRV is a robust predictor of CM health. Lower HRV predicts cardiovascular disease, including first cardiovascular events, even in populations without known CVD. Additionally, lower HRV is associated with higher glucose and A1c among diabetes patients. HRV plays a critical role in regulating allostatic systems that mediate CM disease processes, such as glucose regulation, hypothalamic-pituitary adrenal axis functioning, and inflammation. Not only do HRV and health behaviors precede the onset of full-blown CM disease, but, critically, HRV is responsive to changes in psychosocial conditions, serving as a bridge between psychosocial regulatory processes, such as emotion regulation, and health-related physiological processes, such as allostatic wear-and- tear to CM systems. Similarly, health behaviors, such as physical activity, diet, and sleep, have robust downstream effects on CM health and are responsive to psychosocial intervention. Therefore, establishing psychosocial interventions that influence HRV and health behavior have tremendous potential to protect CM health for at-risk populations before full-blown disease develops.
Intervening with CSPs:
CSPs are at high risk for adverse CM and psychosocial outcomes, and yet, to date, no psychosocial interventions exist to support CSPs to develop more optimal CM regulation and CM health behavior or to reduce psychological factors (e.g., burnout) that may interfere with their service delivery. Addressing burnout among CSPs is particularly critical in the face of the COVID-19 pandemic, which has placed enormous stress on frontline health care workers, impairing their ability to deliver services. These stressors are multiplied for HL and HL-serving CSPs, for whom a global pandemic was overlaid on existing inequalities in stress exposure, due to greater burdens of discrimination, lower socio-economic status, risk of 3 deportation, political scapegoating, and community violence. The lack of interventions for CSPs is a grave oversight, as HL communities depend on the interventions CSPs provide (e.g., diabetes prevention, weight loss) as critical tools for reducing CM disease disparities among HL.
CSPs may be particularly well-suited to RS interventions, as data from Borelli's lab show that CSPs are distressed by the social isolation and disruption the COVID-19 pandemic has wrought, while also finding meaning in novel opportunities to forge connections with a community that needs them more than ever. RS leverages values such as simpatía and familismo, that are central to HL culture and embedded in the work of CSPs. Moreover, CSPs at LHA have been actively involved in developing and delivering RS interventions to the community, have expressed interest in receiving similar "mind-body" focused interventions themselves, and have already noted benefits to themselves from merely delivering RS programming to the community. In a qualitative analysis of interviews with promotores who delivered RS, one CSP noted, ""...I felt motivated too… to continue with… these concepts that you brought, like secure base, safe haven… I practice it a lot with my children… They know that they can always count on me...for whatever they need… and that's exactly what I admit to the families too when I talk to them".
Whereas prior iterations of RS have focused on savoring personal relationships (e.g., parent-child), the proposed study will modify RS to help CSPs savor relationships with community members they serve. Borelli's data suggest that connection to community is a substantial, untapped source of resilience to stress for CSPs during COVID-19. In the words of one promotora, "I didn't have time to stress because I was helping the community and that helped me," Savoring moments of connection in their work may help CSPs cope with stress, bolstering them to continue promoting CM health in the community, while also protecting them from the deleterious effects of stress on their own CM health. Additionally, in so far as it promotes connection to community and reclamation of power, savoring moments of helping others may be a particularly potent antidote to the powerlessness and isolation of both COVID-19 and discrimination.
Therefore, the proposed multilevel study introduces a novel adaptation of RS designed for CSPs who treat CM disease in HL communities and tests its effects at both the individual level (markers of CSP CM disease risk, including HRV) and community level (reach and effectiveness of CSPs delivery of CM interventions). By mitigating the impact of social determinants of health on CSPs, the proposed study protects the health of those who protect the health of the community.
- Conditions
- Heart Rate Variability
- Being tested
- Relational Savoring Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relational Savoring InterventionBehavioural
Relational savoring (RS) involves recalling a time when one supported or comforted another person and doing so brought deep positive emotion (joy, satisfaction, love, or peace); these moments of connection in service of another are common among the CSPs who work for our community agency, but may go unnoticed in the face of the urgent stressors the COVID-19 pandemic has brought about. Prolonging and enhancing attention to these moments has the potential to both help CSPs restore regulation in the face of stress and to motivate CSPs to continue engaging in meaningful work that serves their communities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In this randomized controlled waitlist design, following a baseline assessment, we will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months following the intervention. Receives: Behavioral: Relational Savoring Intervention |
| Waitlist Control Group | Other | In this randomized controlled waitlist design, following a baseline assessment, we will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months following the intervention. Receives: Behavioral: Relational Savoring Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Intervention on Heart Rate Variability
Cardiovascular health was assessed using heart rate variability (HRV) measured during a socially relevant stressor task administered in each intervention session. HRV data were collected using the movisens device, a wearable chest-mounted sensor that records electrocardiogram (ECG) data. Vagally mediated HRV was calculated from the variability of inter-beat (R-R) intervals derived from these ECG recordings. Mean HRV values were calculated for each assessment period, with higher mean HRV values (per minute) indicating greater autonomic regulation and improved cardiovascular health. Due to feasibility and data quality issues with the wearable ECG device, HRV data collection was discontinued after the first two assessment periods (Baseline 1 and the 4-week assessment [post-intervention for the intervention group/Baseline 2 for the waitlist control group]); therefore, post-intervention HRV data were not collected for the waitlist control group.
Measured: Assessed at Baseline 1 for both groups and 4 weeks later (post-intervention for intervention participants and Baseline 2 for waitlist control participants). Post-intervention data were not collected for the waitlist control group.
Acceptability of the Relational Savoring Intervention
Intervention acceptability was assessed using participant self-report items evaluating frequency of use of the intervention skills, perceived value of the intervention, willingness to recommend the intervention to others, and intention to continue engaging in the intervention skills. Acceptability was assessed only after completion of the intervention and at the 3-month follow-up. Acceptability scores were summarized using mean scores reported separately at post-intervention and at the 3-month follow-up across the sample. Possible scores ranged from 0 to 30, with higher scores indicating greater acceptability.
Measured: Immediately following completion of the 4-week intervention and at 3 months post-intervention.
Impact of Intervention on Perceived Closeness to the Community
Perceived closeness to community was assessed using the Inclusion of Other in the Self-Community Version (IOS-C), a single-item visual self-report measure. Participants selected one of seven images depicting increasing overlap between two circles representing the self and the community. Greater overlap indicates greater perceived closeness to the community, whereas less overlap indicates lower perceived closeness. The measure was administered immediately before and after each intervention session (four sessions total). Scores ranged from 1 (not close at all) to 7 (very close), with higher scores indicating greater perceived closeness to the community.
Measured: Immediately before and after each weekly intervention session (Sessions 1-4, approximately 1 hour apart per session), during the 4-week intervention period.
Impact of Intervention on Negative Emotional Valence
Emotional valence was assessed using the valence subscale of the Self-Assessment Manikin (SAM), a nonverbal pictorial self-report measure. Participants selected one of five pictograms ranging from smiling to frowning to indicate their current emotional state. Scores ranged from 1 to 5, with lower scores indicating more positive emotional valence and higher scores indicating more negative emotional valence. The measure was administered immediately before and after each intervention session.
Measured: Immediately before and after each weekly intervention session (Sessions 1-4, approximately 1 hour apart per session), during the 4-week intervention period.
Impact of Intervention on Sleep Quality
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire that assesses subjective sleep quality over the past month. The PSQI yields a global sleep quality score derived from seven component scores, with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Measured: Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Impact of Intervention on Diet
can you revise to make it clear that scoring was dichotomized as ither true or false and thus scores ranged from: Changes in diet-related behavior were assessed using the Emotional Eating subscale of the Three-Factor Eating Questionnaire (TFEQ). The subscale consists of 3 items assessing the extent to which individuals eat in response to emotional states. Items are rated on a 4-point scale ranging from 0 (definitely true) to 3 (definitely false). Item responses were summed to create a total emotional eating score ranging from 0 to 9, with lower scores indicating greater emotional eating and higher scores indicating less emotional eating.
Measured: Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Impact of Intervention on Burnout
Burnout related to the COVID-19 pandemic was assessed using the COVID-19 Burnout Scale, a 10-item self-report measure. Items assess feelings of emotional exhaustion and hopelessness related to the pandemic and are rated on a 7-point scale ranging from 0 (never) to 6 (all the time). Item responses are summed to create a total burnout score ranging from 0 to 60, with higher scores indicating greater burnout. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Measured: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Impact of Intervention on Job Satisfaction
Job satisfaction was assessed using the Job Satisfaction Scale, a 36-item self-report questionnaire measuring participants' overall attitudes toward their job. Items were rated on a 6-point Likert-type scale ranging from 1 (disagree very much) to 6 (agree very much). Item responses were summed to create a total job satisfaction score ranging from 36 to 216, with higher scores indicating greater job satisfaction. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Measured: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Impact of Intervention on Psychological Distress
Psychological distress was assessed using the Brief Symptom Inventory (BSI), a 19-item self-report measure assessing symptoms of depression, anxiety, and somatic distress. Items were rated on a 6-point scale ranging from 0 (not at all) to 5 (extremely). Item responses were summed to create a global psychological distress score ranging from 0 to 95, with higher scores indicating greater overall distress. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Measured: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Impact of Intervention on General Health
General health was assessed using the General Health subscale of the Short Form Health Survey (SF-36). Participants completed the full SF-36 questionnaire, and the 5 items comprising the General Health subscale were scored according to standard SF-36 procedures. Item responses were recoded and summed, and the raw subscale score was transformed to a 0-100 scale, with higher scores indicating better perceived physical health. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Measured: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Impact of Intervention on Community Outreach
Community outreach was assessed using a composite measure of community engagement and reach in community health programming. The composite index captured the extent to which community members were reached by community health programming and was calculated using four indicators: (1) number of days community service providers (CSPs) worked, (2) number of health-related events offered by CSPs, (3) community attendance at CSP-led events, and (4) retention of community members across multi-day programs. Indicators were combined to create a total community outreach score, with higher scores reflecting greater outreach and a higher number of community members reached through community health programming.
Measured: Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start2 Nov 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this randomized controlled waitlist design, following a baseline assessment, the investigators will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Emory University
- Responsible party
- Principal investigator, Jessica Borelli, University of California, Irvine
- Investigators
- Jessica L Borelli, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560893
- Sponsor's protocol ID
- 1596
- Other IDs
- P50MD017366
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2022
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers will use participant information to conduct this study. Once the study is completed, we may share some data with other researchers so they can use it for other studies in the future. IDP sharing plan will be updated.
Publications
Borelli JL, Kerr ML, Smiley PA, Rasmussen HF, Hecht HK, Campos B. Relational savoring intervention: Positive impacts for mothers and evidence of cultural compatibility for Latinas. Emotion. 2023 Mar;23(2):303-320. doi: 10.1037/emo0001102. Epub 2022 May 12.
PubMed 35549365Borelli JL, Smiley PA, Kerr ML, Hong K, Hecht HK, Blackard MB, Falasiri E, Cervantes BR, Bond DK. Relational savoring: An attachment-based approach to promoting interpersonal flourishing. Psychotherapy (Chic). 2020 Sep;57(3):340-351. doi: 10.1037/pst0000284. Epub 2020 Jan 30.
PubMed 31999188Borelli JL, Bond DK, Fox S, Horn-Mallers M. Relational Savoring Reduces Physiological Reactivity and Enhances Psychological Agency in Older Adults. J Appl Gerontol. 2020 Mar;39(3):332-342. doi: 10.1177/0733464819866972. Epub 2019 Aug 11.
PubMed 31402745Lagomasino IT, Dwight-Johnson M, Miranda J, Zhang L, Liao D, Duan N, Wells KB. Disparities in depression treatment for Latinos and site of care. Psychiatr Serv. 2005 Dec;56(12):1517-23. doi: 10.1176/appi.ps.56.12.1517.
PubMed 16339612Paz K, Massey KP. Health Disparity among Latina Women: Comparison with Non-Latina Women. Clin Med Insights Womens Health. 2016 Jul 20;9(Suppl 1):71-4. doi: 10.4137/CMWH.S38488. eCollection 2016.
PubMed 27478393Velasco-Mondragon E, Jimenez A, Palladino-Davis AG, Davis D, Escamilla-Cejudo JA. Hispanic health in the USA: a scoping review of the literature. Public Health Rev. 2016 Dec 7;37:31. doi: 10.1186/s40985-016-0043-2. eCollection 2016.
PubMed 29450072Cabarkapa S, Nadjidai SE, Murgier J, Ng CH. The psychological impact of COVID-19 and other viral epidemics on frontline healthcare workers and ways to address it: A rapid systematic review. Brain Behav Immun Health. 2020 Oct;8:100144. doi: 10.1016/j.bbih.2020.100144. Epub 2020 Sep 17.
PubMed 32959031Danet Danet A. Psychological impact of COVID-19 pandemic in Western frontline healthcare professionals. A systematic review. Med Clin (Engl Ed). 2021 May 7;156(9):449-458. doi: 10.1016/j.medcle.2020.11.003. Epub 2021 Mar 19.
PubMed 33758782Steptoe A, Kivimaki M. Stress and cardiovascular disease. Nat Rev Cardiol. 2012 Apr 3;9(6):360-70. doi: 10.1038/nrcardio.2012.45.
PubMed 22473079Kivimaki M, Virtanen M, Elovainio M, Kouvonen A, Vaananen A, Vahtera J. Work stress in the etiology of coronary heart disease--a meta-analysis. Scand J Work Environ Health. 2006 Dec;32(6):431-42. doi: 10.5271/sjweh.1049.
PubMed 17173200Kloner RA. Lessons learned about stress and the heart after major earthquakes. Am Heart J. 2019 Sep;215:20-26. doi: 10.1016/j.ahj.2019.05.017. Epub 2019 Jun 6.
PubMed 31260902Balcazar H, Alvarado M, Cantu F, Pedregon V, Fulwood R. A promotora de salud model for addressing cardiovascular disease risk factors in the US-Mexico border region. Prev Chronic Dis. 2009 Jan;6(1):A02. Epub 2008 Dec 15.
PubMed 19080008Lujan J, Ostwald SK, Ortiz M. Promotora diabetes intervention for Mexican Americans. Diabetes Educ. 2007 Jul-Aug;33(4):660-70. doi: 10.1177/0145721707304080.
PubMed 17684167O'Brien MJ, Perez A, Alos VA, Whitaker RC, Ciolino JD, Mohr DC, Ackermann RT. The feasibility, acceptability, and preliminary effectiveness of a Promotora-Led Diabetes Prevention Program (PL-DPP) in Latinas: a pilot study. Diabetes Educ. 2015 Aug;41(4):485-94. doi: 10.1177/0145721715586576. Epub 2015 May 28.
PubMed 26023095Philis-Tsimikas A, Fortmann A, Lleva-Ocana L, Walker C, Gallo LC. Peer-led diabetes education programs in high-risk Mexican Americans improve glycemic control compared with standard approaches: a Project Dulce promotora randomized trial. Diabetes Care. 2011 Sep;34(9):1926-31. doi: 10.2337/dc10-2081. Epub 2011 Jul 20.
PubMed 21775748
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- El Corazon de La Comunidad Study - The Purpose of This Research Study is to Develop, Implement, and Evaluate a Community-based Approach to Bolstering the Health and Efficacy of Community Service Providers
- ClinicalTrials.gov ID
- NCT05560893
- Acronym / sponsor ID
- 1596
- Conditions
- Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Emory University
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Posted 10 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Community service providers (CSPs), such as promotores and other community health staff, play an essential role in preserving health and treating disease in underserved Hispanic/Latinx (HL) communities with disproportionately high rates of cardiometabolic (CM) disease. Although effective programs have been developed that deploy CSPs to reduce CM disease risk in the community, to our knowledge no interventions have sought to reduce CM risk among CSPs themselves. However, CSPs are also at high risk for adverse CM outcomes, as they have the same high-risk demographics as the communities they serve and they work in high-stress, frontline jobs. Reducing CM risk among HL CSPs is crucial to promote health at both the individual and community levels; that is, preventive interventions delivered to CSPs may not only promote the health of the individual CSPs who receive the intervention but also may bolster CSPs to more effectively deliver programming that protects CM health community-wide. The proposed study employs relational savoring (RS), a brief intervention rooted in positive psychology and attachment, which has previously been shown to promote psychosocial well-being and which is particularly efficacious in HL populations. Emerging research supports that RS may also promote more optimal cardiovascular regulation and health behavior. Therefore, the investigators deliver RS to CSPs in order to identify CM health protective effects for both CSPs and the high-risk communities they serve.
Aims and Hypotheses:
Aim 1: Examine effects of RS on CSPs' CM risk factors and outcomes. Hypotheses: RS (compared to wait-list control) will be associated with lower CM risk, as indexed by higher mean HRV, both during a stressor and at rest (H1A). RS will also be associated with a more favorable CM health behavior profile, indexed by higher quality sleep, more exercise, and healthier diet (H1B). Aim 2: Examine effects of RS on CSPs' delivery of CM health programming to the community. Hypotheses: RS will be associated both with reduced threats to CSPs leaving the workforce, including higher satisfaction with work, greater agency, and lower burnout (H2A), and with a higher number of community members reached for CM health programming, as indexed by number of days CSP worked, number of health-related events offered by CSPs, community attendance at events, and retention of community members across multi-day programs (H2B).
Detailed description
Although HL Americans face higher CM risk than do non-Hispanic white Americans, they have markedly lower access to healthcare. CSPs, including promotores and frontline community health staff, are community members who serve as hubs of health services provision within low-income HL communities and are critical conduits of the information, support, and care needed to prevent and manage CM disease. Yet as members of the low-income HL communities they serve, CSPs are at risk for the same negative health outcomes as those they support. This risk is amplified by the enormous stress the COVID-19 pandemic has wrought on frontline healthcare workers, such as CSPs. Employment in frontline health work during COVID-19 has been associated with psychological distress, including anxiety, depression, insomnia, and burnout; major and chronic stress, and work stress in particular, in turn, is associated with higher rates of CM disease. Therefore, CPSs are doubly at risk, from both their demographics and their occupation. However, to our knowledge, no intervention programs have been designed to protect CM health among CSPs specifically.
When CSP's health and wellbeing is at risk, the CM health of the larger community hangs in the balance. CSP-led community interventions, such as diabetes and obesity prevention programs, have proven effective, affordable, and well-received in reducing CM risk factors in the community, such as A1c, blood pressure, LDL cholesterol, triglycerides, insulin, sedentary behavior, and overweight. However, the COVID- 19 pandemic has endangered CSPs' abilities to deliver these important programs by placing tremendous demand on CSPs, contributing to professional burnout. Fortifying CSPs to effectively deliver crucial health programming despite enormous contextual burdens may have cascading effects on the CM health of HL communities. In strengthening CSPs that serve low income HL communities, not only does the intervention reduce the risk experienced by the CSPs themselves, but the investigation also stand to strengthen the entire HL community, by investing in the people who disseminate interventions to the community. Thus, brief interventions are needed for CSPs to protect health and to reduce risk factors that may interrupt service delivery to the community, such as burn-out in the face of environmental stress, in order to protect CM health for both CSPs and the communities they serve. Moreover, our community partner, Latino Health Access (LHA), identified programs to support the health and wellbeing of CSPs using a "mind-body approach" as a top priority for their agency.
Relational savoring (RS) is a brief intervention grounded in positive psychology and attachment theory that involves reflecting deeply on a positive emotional experience occurring with another person. The central premise underlying RS is that focusing deeply on moments of positive connection helps to augment the positive emotion and meaning the participants derive from positive interpersonal experiences, in order to enhance fulfillment and satisfaction, resolve distress, and increase one's sense of psychological agency. RS involves recalling a time when one supported or comforted another person and doing so brought deep positive emotion (joy, satisfaction, love, or peace); these moments of connection in service of another are common among the CSPs who work for our community agency, but may go unnoticed in the face of the urgent stressors the COVID-19 pandemic has brought about. Prolonging and enhancing attention to these moments has the potential to both help CSPs restore regulation in the face of stress and to motivate CSPs to continue engaging in meaningful work that serves their communities. RS is a one-on-one intervention that can be led by interveners with minimal training (e.g., undergraduates, promotores) to a high level of fidelity and delivered in brief sessions (30 minutes). Interveners help participants identify a connected memory, then lead participants through a 5-step reflection process that involves deeply focusing on different aspects of the memory. To date, RS has been tested among parents, long-distance partners, military partners during a deployment, older adults, and people in residential psychiatric treatment. RS is particularly effective among HL populations, perhaps because of its congruence with HL values such as simpatía and familismo. RS shows tremendous promise in improving psychological indicators of well-being, including more optimal emotional state, greater relationship satisfaction, interactional quality, and greater psychological agency. Early data support that RS may also shape mechanisms underlying physical health, as RS enhances both health behavior (greater adherence to safety measures during COVID-19) and cardiovascular regulation (lower heart rate while completing RS than while savoring an individual experience). However, RS has yet to be linked with CM health behaviors, such as physical activity, or with CM disease markers, such as heart rate variability (HRV), a non-invasive measure of parasympathetic activity which is linked with CM morbidity and mortality.
Utility of targeting CM disease risk markers through psychosocial interventions:
HRV is a robust predictor of CM health. Lower HRV predicts cardiovascular disease, including first cardiovascular events, even in populations without known CVD. Additionally, lower HRV is associated with higher glucose and A1c among diabetes patients. HRV plays a critical role in regulating allostatic systems that mediate CM disease processes, such as glucose regulation, hypothalamic-pituitary adrenal axis functioning, and inflammation. Not only do HRV and health behaviors precede the onset of full-blown CM disease, but, critically, HRV is responsive to changes in psychosocial conditions, serving as a bridge between psychosocial regulatory processes, such as emotion regulation, and health-related physiological processes, such as allostatic wear-and- tear to CM systems. Similarly, health behaviors, such as physical activity, diet, and sleep, have robust downstream effects on CM health and are responsive to psychosocial intervention. Therefore, establishing psychosocial interventions that influence HRV and health behavior have tremendous potential to protect CM health for at-risk populations before full-blown disease develops.
Intervening with CSPs:
CSPs are at high risk for adverse CM and psychosocial outcomes, and yet, to date, no psychosocial interventions exist to support CSPs to develop more optimal CM regulation and CM health behavior or to reduce psychological factors (e.g., burnout) that may interfere with their service delivery. Addressing burnout among CSPs is particularly critical in the face of the COVID-19 pandemic, which has placed enormous stress on frontline health care workers, impairing their ability to deliver services. These stressors are multiplied for HL and HL-serving CSPs, for whom a global pandemic was overlaid on existing inequalities in stress exposure, due to greater burdens of discrimination, lower socio-economic status, risk of 3 deportation, political scapegoating, and community violence. The lack of interventions for CSPs is a grave oversight, as HL communities depend on the interventions CSPs provide (e.g., diabetes prevention, weight loss) as critical tools for reducing CM disease disparities among HL.
CSPs may be particularly well-suited to RS interventions, as data from Borelli's lab show that CSPs are distressed by the social isolation and disruption the COVID-19 pandemic has wrought, while also finding meaning in novel opportunities to forge connections with a community that needs them more than ever. RS leverages values such as simpatía and familismo, that are central to HL culture and embedded in the work of CSPs. Moreover, CSPs at LHA have been actively involved in developing and delivering RS interventions to the community, have expressed interest in receiving similar "mind-body" focused interventions themselves, and have already noted benefits to themselves from merely delivering RS programming to the community. In a qualitative analysis of interviews with promotores who delivered RS, one CSP noted, ""...I felt motivated too… to continue with… these concepts that you brought, like secure base, safe haven… I practice it a lot with my children… They know that they can always count on me...for whatever they need… and that's exactly what I admit to the families too when I talk to them".
Whereas prior iterations of RS have focused on savoring personal relationships (e.g., parent-child), the proposed study will modify RS to help CSPs savor relationships with community members they serve. Borelli's data suggest that connection to community is a substantial, untapped source of resilience to stress for CSPs during COVID-19. In the words of one promotora, "I didn't have time to stress because I was helping the community and that helped me," Savoring moments of connection in their work may help CSPs cope with stress, bolstering them to continue promoting CM health in the community, while also protecting them from the deleterious effects of stress on their own CM health. Additionally, in so far as it promotes connection to community and reclamation of power, savoring moments of helping others may be a particularly potent antidote to the powerlessness and isolation of both COVID-19 and discrimination.
Therefore, the proposed multilevel study introduces a novel adaptation of RS designed for CSPs who treat CM disease in HL communities and tests its effects at both the individual level (markers of CSP CM disease risk, including HRV) and community level (reach and effectiveness of CSPs delivery of CM interventions). By mitigating the impact of social determinants of health on CSPs, the proposed study protects the health of those who protect the health of the community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this randomized controlled waitlist design, following a baseline assessment, the investigators will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Relational Savoring InterventionIn this randomized controlled waitlist design, following a baseline assessment, we will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months following the intervention. |
| Waitlist Control Group | Other | Behavioral: Relational Savoring InterventionIn this randomized controlled waitlist design, following a baseline assessment, we will randomly assign CSPs into the experimental group (n = 40) or a waitlist group (n = 40). The experimental group will receive the intervention immediately, whereas the waitlist control will wait 4 weeks and have a second baseline assessment before receiving the intervention. All participants will complete an identical assessment battery at pre-intervention baseline, immediately post-intervention, and 3-months following the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria for participants includes being an employee at one of the community health agencies serving low income HL families that we are partnered with (Latino Health Access in Santa Ana or Ser Familia in Atlanta).
Key exclusion criteria (1 listed)
- Not being an employee at one of the community health agencies involved in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relational Savoring InterventionRelational savoring (RS) involves recalling a time when one supported or comforted another person and doing so brought deep positive emotion (joy, satisfaction, love, or peace); these moments of connection in service of another are common among the CSPs who work for our community agency, but may go unnoticed in the face of the urgent stressors the COVID-19 pandemic has brought about. Prolonging and enhancing attention to these moments has the potential to both help CSPs restore regulation in the face of stress and to motivate CSPs to continue engaging in meaningful work that serves their communities. | Behavioural | Intervention Group, Waitlist Control Group |
Primary outcome
Impact of Intervention on Heart Rate Variability
Time frame: Assessed at Baseline 1 for both groups and 4 weeks later (post-intervention for intervention participants and Baseline 2 for waitlist control participants). Post-intervention data were not collected for the waitlist control group.
Cardiovascular health was assessed using heart rate variability (HRV) measured during a socially relevant stressor task administered in each intervention session. HRV data were collected using the movisens device, a wearable chest-mounted sensor that records electrocardiogram (ECG) data. Vagally mediated HRV was calculated from the variability of inter-beat (R-R) intervals derived from these ECG recordings. Mean HRV values were calculated for each assessment period, with higher mean HRV values (per minute) indicating greater autonomic regulation and improved cardiovascular health. Due to feasibility and data quality issues with the wearable ECG device, HRV data collection was discontinued after the first two assessment periods (Baseline 1 and the 4-week assessment [post-intervention for the intervention group/Baseline 2 for the waitlist control group]); therefore, post-intervention HRV data were not collected for the waitlist control group.
Acceptability of the Relational Savoring Intervention
Time frame: Immediately following completion of the 4-week intervention and at 3 months post-intervention.
Intervention acceptability was assessed using participant self-report items evaluating frequency of use of the intervention skills, perceived value of the intervention, willingness to recommend the intervention to others, and intention to continue engaging in the intervention skills. Acceptability was assessed only after completion of the intervention and at the 3-month follow-up. Acceptability scores were summarized using mean scores reported separately at post-intervention and at the 3-month follow-up across the sample. Possible scores ranged from 0 to 30, with higher scores indicating greater acceptability.
Impact of Intervention on Perceived Closeness to the Community
Time frame: Immediately before and after each weekly intervention session (Sessions 1-4, approximately 1 hour apart per session), during the 4-week intervention period.
Perceived closeness to community was assessed using the Inclusion of Other in the Self-Community Version (IOS-C), a single-item visual self-report measure. Participants selected one of seven images depicting increasing overlap between two circles representing the self and the community. Greater overlap indicates greater perceived closeness to the community, whereas less overlap indicates lower perceived closeness. The measure was administered immediately before and after each intervention session (four sessions total). Scores ranged from 1 (not close at all) to 7 (very close), with higher scores indicating greater perceived closeness to the community.
Impact of Intervention on Negative Emotional Valence
Time frame: Immediately before and after each weekly intervention session (Sessions 1-4, approximately 1 hour apart per session), during the 4-week intervention period.
Emotional valence was assessed using the valence subscale of the Self-Assessment Manikin (SAM), a nonverbal pictorial self-report measure. Participants selected one of five pictograms ranging from smiling to frowning to indicate their current emotional state. Scores ranged from 1 to 5, with lower scores indicating more positive emotional valence and higher scores indicating more negative emotional valence. The measure was administered immediately before and after each intervention session.
Impact of Intervention on Sleep Quality
Time frame: Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire that assesses subjective sleep quality over the past month. The PSQI yields a global sleep quality score derived from seven component scores, with total scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Impact of Intervention on Diet
Time frame: Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
can you revise to make it clear that scoring was dichotomized as ither true or false and thus scores ranged from: Changes in diet-related behavior were assessed using the Emotional Eating subscale of the Three-Factor Eating Questionnaire (TFEQ). The subscale consists of 3 items assessing the extent to which individuals eat in response to emotional states. Items are rated on a 4-point scale ranging from 0 (definitely true) to 3 (definitely false). Item responses were summed to create a total emotional eating score ranging from 0 to 9, with lower scores indicating greater emotional eating and higher scores indicating less emotional eating.
Impact of Intervention on Burnout
Time frame: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Burnout related to the COVID-19 pandemic was assessed using the COVID-19 Burnout Scale, a 10-item self-report measure. Items assess feelings of emotional exhaustion and hopelessness related to the pandemic and are rated on a 7-point scale ranging from 0 (never) to 6 (all the time). Item responses are summed to create a total burnout score ranging from 0 to 60, with higher scores indicating greater burnout. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Impact of Intervention on Job Satisfaction
Time frame: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Job satisfaction was assessed using the Job Satisfaction Scale, a 36-item self-report questionnaire measuring participants' overall attitudes toward their job. Items were rated on a 6-point Likert-type scale ranging from 1 (disagree very much) to 6 (agree very much). Item responses were summed to create a total job satisfaction score ranging from 36 to 216, with higher scores indicating greater job satisfaction. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Impact of Intervention on Psychological Distress
Time frame: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Psychological distress was assessed using the Brief Symptom Inventory (BSI), a 19-item self-report measure assessing symptoms of depression, anxiety, and somatic distress. Items were rated on a 6-point scale ranging from 0 (not at all) to 5 (extremely). Item responses were summed to create a global psychological distress score ranging from 0 to 95, with higher scores indicating greater overall distress. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Impact of Intervention on General Health
Time frame: From baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
General health was assessed using the General Health subscale of the Short Form Health Survey (SF-36). Participants completed the full SF-36 questionnaire, and the 5 items comprising the General Health subscale were scored according to standard SF-36 procedures. Item responses were recoded and summed, and the raw subscale score was transformed to a 0-100 scale, with higher scores indicating better perceived physical health. The measure was administered at baseline (1 and 2), post-intervention, and at the 3-month follow-up.
Impact of Intervention on Community Outreach
Time frame: Baseline (prior to intervention), immediately following completion of the 4-week intervention, and at 3 months post-intervention.
Community outreach was assessed using a composite measure of community engagement and reach in community health programming. The composite index captured the extent to which community members were reached by community health programming and was calculated using four indicators: (1) number of days community service providers (CSPs) worked, (2) number of health-related events offered by CSPs, (3) community attendance at CSP-led events, and (4) retention of community members across multi-day programs. Indicators were combined to create a total community outreach score, with higher scores reflecting greater outreach and a higher number of community members reached through community health programming.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35549365Borelli JL, Kerr ML, Smiley PA, Rasmussen HF, Hecht HK, Campos B. Relational savoring intervention: Positive impacts for mothers and evidence of cultural compatibility for Latinas. Emotion. 2023 Mar;23(2):303-320. doi: 10.1037/emo0001102. Epub 2022 May 12.
- Background: PubMed 31999188Borelli JL, Smiley PA, Kerr ML, Hong K, Hecht HK, Blackard MB, Falasiri E, Cervantes BR, Bond DK. Relational savoring: An attachment-based approach to promoting interpersonal flourishing. Psychotherapy (Chic). 2020 Sep;57(3):340-351. doi: 10.1037/pst0000284. Epub 2020 Jan 30.
- Background: PubMed 31402745Borelli JL, Bond DK, Fox S, Horn-Mallers M. Relational Savoring Reduces Physiological Reactivity and Enhances Psychological Agency in Older Adults. J Appl Gerontol. 2020 Mar;39(3):332-342. doi: 10.1177/0733464819866972. Epub 2019 Aug 11.
- Background: PubMed 16339612Lagomasino IT, Dwight-Johnson M, Miranda J, Zhang L, Liao D, Duan N, Wells KB. Disparities in depression treatment for Latinos and site of care. Psychiatr Serv. 2005 Dec;56(12):1517-23. doi: 10.1176/appi.ps.56.12.1517.
- Background: PubMed 27478393Paz K, Massey KP. Health Disparity among Latina Women: Comparison with Non-Latina Women. Clin Med Insights Womens Health. 2016 Jul 20;9(Suppl 1):71-4. doi: 10.4137/CMWH.S38488. eCollection 2016.
- Background: PubMed 29450072Velasco-Mondragon E, Jimenez A, Palladino-Davis AG, Davis D, Escamilla-Cejudo JA. Hispanic health in the USA: a scoping review of the literature. Public Health Rev. 2016 Dec 7;37:31. doi: 10.1186/s40985-016-0043-2. eCollection 2016.
- Background: PubMed 32959031Cabarkapa S, Nadjidai SE, Murgier J, Ng CH. The psychological impact of COVID-19 and other viral epidemics on frontline healthcare workers and ways to address it: A rapid systematic review. Brain Behav Immun Health. 2020 Oct;8:100144. doi: 10.1016/j.bbih.2020.100144. Epub 2020 Sep 17.
- Background: PubMed 33758782Danet Danet A. Psychological impact of COVID-19 pandemic in Western frontline healthcare professionals. A systematic review. Med Clin (Engl Ed). 2021 May 7;156(9):449-458. doi: 10.1016/j.medcle.2020.11.003. Epub 2021 Mar 19.
- Background: PubMed 22473079Steptoe A, Kivimaki M. Stress and cardiovascular disease. Nat Rev Cardiol. 2012 Apr 3;9(6):360-70. doi: 10.1038/nrcardio.2012.45.
- Background: PubMed 17173200Kivimaki M, Virtanen M, Elovainio M, Kouvonen A, Vaananen A, Vahtera J. Work stress in the etiology of coronary heart disease--a meta-analysis. Scand J Work Environ Health. 2006 Dec;32(6):431-42. doi: 10.5271/sjweh.1049.
- Background: PubMed 31260902Kloner RA. Lessons learned about stress and the heart after major earthquakes. Am Heart J. 2019 Sep;215:20-26. doi: 10.1016/j.ahj.2019.05.017. Epub 2019 Jun 6.
- Background: PubMed 19080008Balcazar H, Alvarado M, Cantu F, Pedregon V, Fulwood R. A promotora de salud model for addressing cardiovascular disease risk factors in the US-Mexico border region. Prev Chronic Dis. 2009 Jan;6(1):A02. Epub 2008 Dec 15.
- Individual participant dataSharing planned: No. Researchers will use participant information to conduct this study. Once the study is completed, we may share some data with other researchers so they can use it for other studies in the future. IDP sharing plan will be updated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica L Borelli, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relational Savoring Intervention in people with Heart Rate Variability, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Intervention on Heart Rate Variability (time frame: Assessed at Baseline 1 for both groups and 4 weeks later (post-intervention for intervention participants and Baseline 2 for waitlist control participants). Post-intervention data were not collected for the waitlist control group.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05560893, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.