A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension: Protocol and Design for the ¡Alégrate! Randomized Controlled Trial

Rosalba Hernandez, Michael Cohn, Alison Hernandez, Martha Daviglus, Lizet Martinez, Angela Martinez, Itzel Martinez, Ramon Durazo-Arvizu, Judith Moskowitz, Rosalba Hernandez, Michael Cohn, Alison Hernandez, Martha Daviglus, Lizet Martinez, Angela Martinez, Itzel Martinez, Ramon Durazo-Arvizu, Judith Moskowitz

Abstract

Background: Growing evidence links psychological well-being and resilience with superior cardiac health, but there remains a critical scientific gap about whether (or how) interventions that aim to cultivate psychological well-being reduce cardiac risk. Hispanic/Latino people in the United States have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared with their peers of European ancestry, and they represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults; to date, however, no research has explored whether a causal link is evident.

Objective: The aim of this paper is to detail the protocol for the ¡Alégrate! (Be Happy!) intervention, a Phase II randomized controlled trial testing initial efficacy in improving BP of a web-based positive psychological intervention designed to boost psychological well-being in Spanish-speaking Hispanic/Latino people with hypertension.

Methods: A total of 70 Hispanic/Latino people aged ≥18 years, fluent in Spanish, and with elevated BP (≥140/90 mm Hg) will be recruited in person from a single Federally Qualified Health Center in Chicago. Enrollees will be randomly assigned to 1 of 2 trial arms: (1) web-based positive psychological intervention or (2) an active control condition (eg, 3 times weekly emotion reporting). Our 5-week Spanish-language ¡Alégrate! intervention is web-based and delivers curricular content via didactic instruction, journaling, and assigned at-home practice-all accessed via our website using investigator-purchased tablet computers, with a unique username and password assigned to each enrollee. Targeted skills 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. The primary outcome is improvement in BP, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5 and 12 weeks from baseline. Secondary outcomes include psychological well-being, engagement in healthy behaviors, and circulating levels of inflammatory markers. The outcomes of interest are collected by trained research staff through in-person interviews using the REDCap software.

Results: Activities of the ¡Alégrate! intervention were funded in August 2017, and data collection is ongoing. We expect to submit trial results for peer-reviewed publications in 2021, soon after recruitment has been concluded and statistical analyses are finalized.

Conclusions: Findings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on BP control and cardiovascular health, particularly as they are deployed in the Spanish language with cultural tailoring and via a web-based platform. If effective, we will have an easily disseminatable application that can positively impact well-being profiles and BP control in Hispanic/Latino people, with the possibility of addressing health disparities of this US racial/ethnic minority group.

Trial registration: ClinicalTrials.gov NCT03892057; https://ichgcp.net/clinical-trials-registry/NCT03892057.

International registered report identifier (irrid): PRR1-10.2196/17721.

Keywords: Hispanic Americans; blood pressure; culture; emotions; happiness; hypertension; positive psychology; telemedicine.

Conflict of interest statement

Conflicts of Interest: None declared.

©Rosalba Hernandez, Michael Cohn, Alison Hernandez, Martha Daviglus, Lizet Martinez, Angela Martinez, Itzel Martinez, Ramon Durazo-Arvizu, Judith Moskowitz. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.08.2020.

Figures

Figure 1
Figure 1
Recruitment and assessment timeline for the ¡Alégrate! web-based intervention.
Figure 2
Figure 2
Screenshots of our Spanish-language internet-based positive psychological intervention accessed via a web browser.

References

    1. Merai R, Siegel C, Rakotz M, Basch P, Wright J, Wong B, DHSc. Thorpe P. CDC grand rounds: a public health approach to detect and control hypertension. MMWR Morb Mortal Wkly Rep. 2016 Nov 18;65(45):1261–4. doi: 10.15585/mmwr.mm6545a3. doi: 10.15585/mmwr.mm6545a3.
    1. Yoon S, Carroll MD, Fryar CD. Hypertension prevalence and control among adults: United States, 2011-2014. NCHS Data Brief. 2015 Nov;(220):1–8.
    1. Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB, American Heart Association Statistics Committee and Stroke Statistics Subcommittee Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29–322. doi: 10.1161/CIR.0000000000000152.
    1. Carey RM, Sakhuja S, Calhoun DA, Whelton PK, Muntner P. Prevalence of apparent treatment-resistant hypertension in the United States. Hypertension. 2019 Feb;73(2):424–31. doi: 10.1161/HYPERTENSIONAHA.118.12191.
    1. Sin NL. The protective role of positive well-being in cardiovascular disease: review of current evidence, mechanisms, and clinical implications. Curr Cardiol Rep. 2016 Nov;18(11):106. doi: 10.1007/s11886-016-0792-z.
    1. DuBois CM, Lopez OV, Beale EE, Healy BC, Boehm JK, Huffman JC. Relationships between positive psychological constructs and health outcomes in patients with cardiovascular disease: a systematic review. Int J Cardiol. 2015 Sep 15;195:265–80. doi: 10.1016/j.ijcard.2015.05.121.
    1. Boehm JK, Kubzansky LD. The heart's content: the association between positive psychological well-being and cardiovascular health. Psychol Bull. 2012 Jul;138(4):655–91. doi: 10.1037/a0027448.
    1. Kubzansky LD, Huffman JC, Boehm JK, Hernandez R, Kim ES, Koga HK, Feig EH, Lloyd-Jones DM, Seligman ME, Labarthe DR. Positive psychological well-being and cardiovascular disease: JACC health promotion series. J Am Coll Cardiol. 2018 Sep 18;72(12):1382–96. doi: 10.1016/j.jacc.2018.07.042.
    1. Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719–27. doi: 10.1037//0022-3514.69.4.719.
    1. Emotional Well-Being: Emerging Insights and Questions for Future Research. National Center for Complementary and Integrative Health (NCCIH) 2018. [2020-05-28]. .
    1. Waterman AS. Reconsidering happiness: a eudaimonist's perspective. J Posit Psychol. 2008 Oct;3(4):234–52. doi: 10.1080/17439760802303002.
    1. Daviglus ML, Talavera GA, Avilés-Santa ML, Allison M, Cai J, Criqui MH, Gellman M, Giachello AL, Gouskova N, Kaplan RC, LaVange L, Penedo F, Perreira K, Pirzada A, Schneiderman N, Wassertheil-Smoller S, Sorlie PD, Stamler J. Prevalence of major cardiovascular risk factors and cardiovascular diseases among Hispanic/Latino individuals of diverse backgrounds in the United States. J Am Med Assoc. 2012 Nov 7;308(17):1775–84. doi: 10.1001/jama.2012.14517.
    1. Hispanic Health. Centers for Disease Control and Prevention. 2015. [2015-05-15]. .
    1. Guzman NJ. Epidemiology and management of hypertension in the Hispanic population: a review of the available literature. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):165–78. doi: 10.2165/11631520-000000000-00000.
    1. Rodriguez F, Hu J, Kershaw K, Hastings KG, López L, Cullen MR, Harrington RA, Palaniappan LP. County-level Hispanic ethnic density and cardiovascular disease mortality. J Am Heart Assoc. 2018 Oct 2;7(19):e009107. doi: 10.1161/JAHA.118.009107.
    1. Balfour PC, Ruiz JM, Talavera GA, Allison MA, Rodriguez CJ. Cardiovascular disease in Hispanics/Latinos in the United States. J Lat Psychol. 2016 May;4(2):98–113. doi: 10.1037/lat0000056.
    1. Brown LD, Vasquez D, Salinas JJ, Tang X, Balcázar H. Cardiovascular disease in Hispanics/Latinos in the united evaluation of healthy fit: a community health worker model to address Hispanic health disparities. Prev Chronic Dis. 2018 Apr 26;15:E49. doi: 10.5888/pcd15.170347.
    1. González HM, Tarraf W, Rodríguez CJ, Gallo LC, Sacco RL, Talavera GA, Heiss G, Kizer JR, Hernandez R, Davis S, Schneiderman N, Daviglus ML, Kaplan RC. Cardiovascular health among diverse Hispanics/Latinos: Hispanic community health study/study of Latinos (HCHS/SOL) results. Am Heart J. 2016 Jun;176:134–44. doi: 10.1016/j.ahj.2016.02.008.
    1. Hernandez R, Cheung E, Carnethon M, Penedo FJ, Moskowitz JT, Martinez L, Schueller SM. Feasibility of a culturally adapted positive psychological intervention for Hispanics/Latinos with elevated risk for cardiovascular disease. Transl Behav Med. 2018 Nov 21;8(6):887–97. doi: 10.1093/tbm/iby045.
    1. McNulty J, Kim W, Thurston T, Kim J, Larkey L. Interventions to improve quality of life, well-being, and care in Latino cancer survivors: a systematic literature review. Oncol Nurs Forum. 2016 May 1;43(3):374–84. doi: 10.1188/16.ONF.374-384.
    1. Hernandez R, Bassett SM, Boughton SW, Schuette SA, Shiu EW, Moskowitz JT. Psychological well-being and physical health: associations, mechanisms, and future directions. Emot Rev. 2017 Oct 20;10(1):18–29. doi: 10.1177/1754073917697824.
    1. Ogedegbe GO, Boutin-Foster C, Wells MT, Allegrante JP, Isen AM, Jobe JB, Charlson ME. A randomized controlled trial of positive-affect intervention and medication adherence in hypertensive African Americans. Arch Intern Med. 2012 Feb 27;172(4):322–6. doi: 10.1001/archinternmed.2011.1307.
    1. Richman LS, Kubzansky L, Maselko J, Kawachi I, Choo P, Bauer M. Positive emotion and health: going beyond the negative. Health Psychol. 2005 Jul;24(4):422–9. doi: 10.1037/0278-6133.24.4.422.
    1. Centers for Disease Control and Prevention (CDC) Racial/Ethnic disparities in the awareness, treatment, and control of hypertension - United States, 2003-2010. MMWR Morb Mortal Wkly Rep. 2013 May 10;62(18):351–5.
    1. Ploeg J, Markle-Reid M, Valaitis R, McAiney C, Duggleby W, Bartholomew A, Sherifali D. Web-based interventions to improve mental health, general caregiving outcomes, and general health for informal caregivers of adults with chronic conditions living in the community: rapid evidence review. J Med Internet Res. 2017 Jul 28;19(7):e263. doi: 10.2196/jmir.7564.
    1. Larsen B, Marcus B, Pekmezi D, Hartman S, Gilmer T. A web-based physical activity intervention for Spanish-speaking Latinas: a costs and cost-effectiveness analysis. J Med Internet Res. 2017 Feb 22;19(2):e43. doi: 10.2196/jmir.6257.
    1. Manganello JA, Gerstner G, Pergolino K, Graham Y, Strogatz D. Media and technology use among Hispanics/Latinos in New York: implications for health communication programs. J Racial Ethn Health Disparities. 2016 Sep;3(3):508–17. doi: 10.1007/s40615-015-0169-9.
    1. Reidy MC, Orpinas P, Davis M. Successful recruitment and retention of Latino study participants. Health Promot Pract. 2012 Nov;13(6):779–87. doi: 10.1177/1524839911405842.
    1. Brown L, Bryant C, Judd FK. Positive well-being during the menopausal transition: a systematic review. Climacteric. 2015;18(4):456–69. doi: 10.3109/13697137.2014.989827.
    1. Brown M, Glendenning A, Hoon AE, John A. Effectiveness of web-delivered acceptance and commitment therapy in relation to mental health and well-being: a systematic review and meta-analysis. J Med Internet Res. 2016 Aug 24;18(8):e221. doi: 10.2196/jmir.6200.
    1. Hadjiconstantinou M, Byrne J, Bodicoat DH, Robertson N, Eborall H, Khunti K, Davies MJ. Do web-based interventions improve well-being in type 2 diabetes? A systematic review and meta-analysis. J Med Internet Res. 2016 Oct 21;18(10):e270. doi: 10.2196/jmir.5991.
    1. Powell J, Hamborg T, Stallard N, Burls A, McSorley J, Bennett K, Griffiths KM, Christensen H. Effectiveness of a web-based cognitive-behavioral tool to improve mental well-being in the general population: randomized controlled trial. J Med Internet Res. 2012 Dec 31;15(1):e2. doi: 10.2196/jmir.2240.
    1. Davies EB, Morriss R, Glazebrook C. Computer-delivered and web-based interventions to improve depression, anxiety, and psychological well-being of university students: a systematic review and meta-analysis. J Med Internet Res. 2014 May 16;16(5):e130. doi: 10.2196/jmir.3142.
    1. Schueller SM, Hunter JF, Figueroa C, Aguilera A. Use of digital mental health for marginalized and underserved populations. Curr Treat Options Psych. 2019 Jul 5;6(3):243–55. doi: 10.1007/s40501-019-00181-z.
    1. Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975 Oct;23(10):433–41. doi: 10.1111/j.1532-5415.1975.tb00927.x.
    1. Moskowitz JT, Cheung EO, Snowberg KE, Verstaen A, Merrilees J, Salsman JM, Dowling GA. Randomized controlled trial of a facilitated online positive emotion regulation intervention for dementia caregivers. Health Psychol. 2019 May;38(5):391–402. doi: 10.1037/hea0000680.
    1. Moskowitz JT, Hult JR, Duncan LG, Cohn MA, Maurer S, Bussolari C, Acree M. A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test. J Health Psychol. 2012 Jul;17(5):676–92. doi: 10.1177/1359105311425275.
    1. Moskowitz JT, Carrico AW, Duncan LG, Cohn MA, Cheung EO, Batchelder A, Martinez L, Segawa E, Acree M, Folkman S. Randomized controlled trial of a positive affect intervention for people newly diagnosed with HIV. J Consult Clin Psychol. 2017 May;85(5):409–23. doi: 10.1037/ccp0000188.
    1. Cheung EO, Addington EL, Bassett SM, Schuette SA, Shiu EW, Cohn MA, Leykin Y, Saslow LR, Moskowitz JT. A self-paced, web-based, positive emotion skills intervention for reducing symptoms of depression: protocol for development and pilot testing of marigold. JMIR Res Protoc. 2018 Jun 5;7(6):e10494. doi: 10.2196/10494.
    1. Cohn MA, Pietrucha ME, Saslow LR, Hult JR, Moskowitz JT. An online positive affect skills intervention reduces depression in adults with type 2 diabetes. J Posit Psychol. 2014 Jan 1;9(6):523–34. doi: 10.1080/17439760.2014.920410.
    1. Cheung EO, Cohn MA, Dunn LB, Melisko ME, Morgan S, Penedo FJ, Salsman JM, Shumay DM, Moskowitz JT. A randomized pilot trial of a positive affect skill intervention (lessons in linking affect and coping) for women with metastatic breast cancer. Psychooncology. 2017 Dec;26(12):2101–8. doi: 10.1002/pon.4312.
    1. Hernandez R, Daviglus ML, Martinez L, Durazo-Arvizu RA, Huffman JC, Ramirez F, Tito L, Moskowitz JT. 'A culturally adapted positive psychological intervention for Hispanics/Latinos with hypertension: rationale, design, and methods. Contemp Clin Trials Commun. 2019 Jun;14:100348. doi: 10.1016/j.conctc.2019.100348.
    1. Positive Psychological Intervention. ¡Alégrate! 2018. [2020-05-28]. .
    1. Sorlie PD, Avilés-Santa LM, Wassertheil-Smoller S, Kaplan RC, Daviglus ML, Giachello AL, Schneiderman N, Raij L, Talavera G, Allison M, Lavange L, Chambless LE, Heiss G. Design and implementation of the Hispanic community health study/study of Latinos. Ann Epidemiol. 2010 Aug;20(8):629–41. doi: 10.1016/j.annepidem.2010.03.015.
    1. Bild D, Bluemke DA, Burke GL, Detrano R, Roux AV, Folsom AR, Greenland P, Jacob DR, Kronmal R, Liu K, Nelson JC, O'Leary D, Saad MF, Shea S, Szklo M, Tracy RP. Multi-ethnic study of atherosclerosis: objectives and design. Am J Epidemiol. 2002 Nov 1;156(9):871–81. doi: 10.1093/aje/kwf113.
    1. Mena LJ, Felix VG, Ostos R, Gonzalez JA, Cervantes A, Ochoa A, Ruiz C, Ramos R, Maestre GE. Mobile personal health system for ambulatory blood pressure monitoring. Comput Math Methods Med. 2013;2013:598196. doi: 10.1155/2013/598196. doi: 10.1155/2013/598196.
    1. Linden W, Lenz JW, Con AH. Individualized stress management for primary hypertension: a randomized trial. Arch Intern Med. 2001 Apr 23;161(8):1071–80. doi: 10.1001/archinte.161.8.1071.
    1. Radloff LS. The CES-D scale. Appl Psychol Meas. 2016 Jul 26;1(3):385–401. doi: 10.1177/014662167700100306.
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385–96.
    1. Perera MJ, Brintz CE, Birnbaum-Weitzman O, Penedo FJ, Gallo LC, Gonzalez P, Gouskova N, Isasi CR, Navas-Nacher EL, Perreira KM, Roesch SC, Schneiderman N, Llabre MM. Factor structure of the perceived stress scale-10 (PSS) across English and Spanish language responders in the HCHS/SOL sociocultural ancillary study. Psychol Assess. 2017 Mar;29(3):320–8. doi: 10.1037/pas0000336.
    1. Fredrickson BL, Tugade MM, Waugh CE, Larkin GR. What good are positive emotions in crises? A prospective study of resilience and emotions following the terrorist attacks on the United States on September 11th, 2001. J Pers Soc Psychol. 2003 Feb;84(2):365–76. doi: 10.1037//0022-3514.84.2.365.
    1. Scheier MF, Carver CS. Optimism, coping, and health: assessment and implications of generalized outcome expectancies. Health Psychol. 1985;4(3):219–47. doi: 10.1037//0278-6133.4.3.219.
    1. Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the life orientation test. J Pers Soc Psychol. 1994 Dec;67(6):1063–78. doi: 10.1037//0022-3514.67.6.1063.
    1. Kubzansky LD, Thurston RC. Emotional vitality and incident coronary heart disease: benefits of healthy psychological functioning. Arch Gen Psychiatry. 2007 Dec;64(12):1393–401. doi: 10.1001/archpsyc.64.12.1393.
    1. Fazio A. A concurrent validational study of the NCHS general well-being schedule. Vital Health Stat 2. 1977 Sep;(73):1–53.
    1. Scheier MF, Wrosch C, Baum A, Cohen S, Martire LM, Matthews KA, Schulz R, Zdaniuk B. The life engagement test: assessing purpose in life. J Behav Med. 2006 Jun;29(3):291–8. doi: 10.1007/s10865-005-9044-1.
    1. Warner RM, Vroman KG. Happiness inducing behaviors in everyday life: an empirical assessment of 'the how of happiness'. J Happiness Stud. 2011 Jan 4;12(6):1063–82. doi: 10.1007/s10902-010-9245-3.
    1. Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705–14. doi: 10.1016/0277-9536(91)90150-b.
    1. Ross L, Chong SH, Mason B, Healy H. Development and evaluation of a scored sodium questionnaire-screening form for kidney disease patients. J Ren Nutr. 2016 May;26(3):159–67. doi: 10.1053/j.jrn.2015.10.006.
    1. Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943–50. doi: 10.2337/diacare.23.7.943.
    1. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67–74. doi: 10.1097/00005650-198601000-00007.
    1. Marin G, Sabogal F, Marin BV, Otero-Sabogal R, Perez-Stable EJ. Development of a short acculturation scale for Hispanics. Hisp J Behav Sci. 2016 Jul 25;9(2):183–205. doi: 10.1177/07399863870092005.
    1. Koenig HG, Büssing A. The Duke university religion index (DUREL): a five-item measure for use in epidemological studies. Religions. 2010 Dec 1;1(1):78–85. doi: 10.3390/rel1010078.
    1. Ware J, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220–33. doi: 10.1097/00005650-199603000-00003.
    1. Frison L, Pocock SJ. Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Stat Med. 1992 Sep 30;11(13):1685–704. doi: 10.1002/sim.4780111304.
    1. Linden W, Chambers L. Clinical effectiveness of non-drug treatment for hypertension: a meta-analysis. Ann Behav Med. 1994;16(1):35–45. doi: 10.1093/abm/16.1.35.
    1. Stata Statistical Software: Release 15 College Station. Stata: Software for Statistics and Data Science. 2017. [2018-03-01].

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit