Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 7, 2020
Date Accepted: Apr 22, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Randomized Controlled Trial of a Web-based Positive Psychological Intervention to Improve Blood Pressure Control in Hispanic/Latino Adults: Protocol and Design of the ¡Alégrate! Trial
ABSTRACT
Background:
Growing evidence links psychological well-being and resilience (e.g., optimism, happiness) with superior cardiac health, but there remains a critical scientific gap as we do not know whether (or how) interventions to cultivate psychological well-being may reduce cardiac risk. Hispanics/Latinos in the U.S. have high cardiovascular disease risk and poorly controlled blood pressure compared to peers of European ancestry, and represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being and resilience holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults—to date, however, no research explores whether a causal link is evident.
Objective:
The aim of the current study is to detail the study protocol of the ¡Alégrate! [Be Happy!] intervention, a Phase II randomized controlled trial (RCT) testing efficacy in improving blood pressure of a Web-based positive psychological intervention designed to boost psychological well-being and resilience in Hispanics/Latinos with hypertension.
Methods:
A total of 70 Hispanics/Latinos aged ≥18 years, fluent in Spanish, and with elevated blood pressure (i.e., ≥140/90mmHg) will participate in one of two trial arms: (1) Web-based positive psychological intervention, or (2) an active control condition (e.g., thrice weekly emotion reporting). Our 5-week ¡Alégrate! intervention is Web-based and delivers curricular content via didactic instruction (e.g., text, videos), journaling, and assigned at-home practice—all accessed online using investigator-purchased tablet computers, with unique username and passwords assigned to each enrollee. Targeted skills of ¡Alégrate! include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation, among others. The primary outcome is improvement in blood pressure values, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5- and 12-weeks post-baseline. Secondary outcomes include emotional well-being, engagement in healthful behaviors, and circulating levels of inflammatory markers.
Results:
Activities of the ¡Alégrate! intervention were funded in 2017, and data collection is on-going. We expect to submit trial results for peer-reviewed publication in 2021, soon after recruitment has concluded and statistical analysis are finalized.
Conclusions:
Findings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on blood pressure control and cardiovascular health, particularly as deployed in the Spanish-language with cultural tailoring and via a Web-based platform. If the ¡Alégrate! intervention proves to be effective, we will have an easily disseminatable Web-based application that can positively impact emotional well-being profiles and blood pressure control in Hispanic/Latino adults—with, the possibility of addressing health disparities experienced by this U.S. racial/ethnic minority group using a cost-effective and flexible on-line strategy. Clinical Trial: The ¡Alégrate! trial is registered at clinicaltrials.gov under registration number NCT03892057.
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