The mastery lifestyle intervention to reduce biopsychosocial risks for pregnant Latinas and African Americans and their infants: protocol for a randomized controlled trial

R Jeanne Ruiz, Kristyn Grimes, Elizabeth Spurlock, Angela Stotts, Thomas F Northrup, Yolanda Villarreal, Robert Suchting, Melissa Cernuch, Liza Rivera, Raymond P Stowe, Rita H Pickler, R Jeanne Ruiz, Kristyn Grimes, Elizabeth Spurlock, Angela Stotts, Thomas F Northrup, Yolanda Villarreal, Robert Suchting, Melissa Cernuch, Liza Rivera, Raymond P Stowe, Rita H Pickler

Abstract

Background: Pregnant Mexican Americans (hereafter called Latinas) and Black/African American women are at increased risk for psychological distress, contributing to preterm birth and low birthweight; acculturative stress combined with perceived stress elevates depressive symptoms in Latinas. Based on our prior research using a psychoneuroimmunology framework, we identified psychological and neuroendocrine risk factors as predictors of preterm birth in Latina women that are also identified as risk factors for Black/African American women.

Methods/design: In this prospective, randomized controlled trial with parallel group design we will explore psychosocial, neuroendocrine, and birth outcome effects of the Mastery Lifestyle Intervention (MLI). The MLI is a culturally relevant, manualized, psychosocial, group intervention integrating two cognitive behavioral therapies for both pregnant Latinas and Black/African American women (total n = 221). Study inclusion criteria are: women with current pregnancy at 14-20 weeks gestation, ability to read and speak English or Spanish, self-identify as Latina of Mexican heritage or Black/African American, 18-45 years old, born in the US or Mexico, and currently living in the US. Participants must receive Medicaid or other government-supported insurance, and meet screening criteria for anxiety, depressive symptoms, or stress. Participants are randomly assigned to either the intervention (MLI) or usual care group (UCG) in groups of 6-8 participants that occur over 6 consecutive weeks. Data are collected at 3 time points: enrollment (14-20 weeks gestation), following treatment (20-26 weeks), and 6 weeks after treatment (32-36 weeks gestation). Additional outcome, mediating, and moderating data are collected from the electronic health record during pregnancy and at birth. Analyses will primarily use generalized linear mixed modeling (GLMM) to evaluate the relationships between predictors and outcomes.

Discussion: This RCT will test the efficacy of two combined third generation cognitive behavioral therapies (the MLI), given in a group format over 6 sessions, as compared to a usual prenatal care group, for both Latina and African American pregnant women. If efficacious, it may be provided as an adjunct to routine prenatal care and improve mental health, as well as babies being born too small and too soon.

Trial registration: The trial was retrospectively registered at ClinicalTrials.gov . Bethesda (MD): National Library of Medicine. Identifier NCT05012072 , Reducing Pregnancy Risks: The Mastery Lifestyle Intervention (MLI); August 19, 2021. The trial is currently recruiting participants.

Keywords: Acceptance and commitment therapy; African Americans; Corticotrophin-releasing hormone; Estriol; Infant outcomes; Latinas; Problem solving therapy; Progesterone; Psychological outcomes.

Conflict of interest statement

All authors declare they have no competing interests.

© 2022. The Author(s).

Figures

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Fig. 1
CONSORT flow diagram

References

    1. Staneva A, Bogossian F, Pritchard M, Wittkowski A. The effects of maternal depresiion, anxiety, and the birth during pregnancy on preterm birth: a systematic review. Women Birth. 2015;28(3):179–193.
    1. Martin JA, Osterman MJK. Describing the increase in preterm births in the United States 2014–2016. NCHS Data Brief, Center for Disease Control and Prevention. 2018. p. 312.
    1. Ponting C, Mahrer NE, Zelcer H, Dunkel Schetter C, Chavira DA. Psychological interventions for depression and anxiety in pregnant Latina and black women in the United States: a systematic review. Clin Psychol Psychother. 2020;27(2):249–265.
    1. Goodman JH, Tyer-Viola L. Detection, treatment, and referral of perinatal depression and anxiety by obstetrical providers. J Women's Health. 2010;19(3):477–490.
    1. Levy LB, O'Hara MW. Psychotherapeutic interventions for depressed, low-income women: a review of the literature. Clin Psychol Rev. 2010;30(8):934–950.
    1. Behrman RE, Butler AS. Preterm birth, causes, consequences and prevention. Washington, D.C.: National Academies Press; 2007.
    1. Di Renzo GC, Tosto V, Giardina I. The biological basis and prevention of preterm birth. Best Pract Res Clin Obstet Gynaecol. 2018;52:13–22.
    1. Davey MA, Watson L, Rayner JA, Rowlands S. Risk-scoring systems for predicting preterm birth with the aim of reducing associated adverse outcomes. Cochrane Database Syst Rev. 2015;10:CD004902.
    1. Jarde A, Morais M, Kingston D, Giallo R, MacQueen GM, Giglia L, et al. Neonatal outcomes in women with untreated antenatal depression compared with women without depression: a systematic review and meta-analysis. JAMA Psychiatry. 2016;73(8):826–837.
    1. Lilliecreutz C, Laren J, Sudsjok G, Josefsson A. Effect of maternal stress during pregnancy on the risk for preterm birth. BMC Pregnancy Childbirth. 2016;16:5.
    1. Wadhwa PD, Entringer S, Buss C, Lu MC. The contribution of maternal stress to preterm birth: issues and considerations. Clin Perinatol. 2011;38(3):351–384.
    1. Ruiz RJ, Newman M, Records K, Wommack JC, Stowe RP, Pasillas RM. Pilot study of the mastery lifestyle intervention. Nurs Res. 2019;68(6):494–500.
    1. D’Anna KL, Hoffman C, Zerbe GO, Coussons Read M, Ross R, Laudenslager ML. Acculturation, maternal cortisol and birth outcomes in women of Mexican descent. Psychosom Med. 2012;74:296–304.
    1. D’Anna-Hernandez KL, Aleman B, Flores AM. Acculturative stress negatively impacts maternal depressive symptoms in Mexican-American women during pregnancy. J Affect Disord. 2015;176:35–42.
    1. Preciado A, D’Anna-Hernandez K. Acculturative stress is associated with trajectory of anxiety symptoms during pregnancy in Mexican-American women. J Anxiety Disord. 2017;48:28–35.
    1. Marcus SM, Flynn HA, Blow FC, Barry KL. Depressive symptoms among pregnant women screened in obstetrics settings. J Women’s Health. 2003;12(4):373–380.
    1. Pearson RM, Evans J, Kounali D, Lewis G, Heron J, Ramchandani PG, et al. Maternal depression during pregnancy and the postnatal period: risks and possible mechanisms for offspring depression at age 18 years. JAMA Psychiatry. 2013;70(12):1312–1319.
    1. Wadhwa PD, Culhane JF, Rauh V, Barve SS, Hogan V, Sandman CA, et al. Stress, infection and preterm birth: a biobehavioural perspective. Paediatr Perinat Epidemiol. 2001;15:17–29.
    1. Chrousos GP, Gold PW. The concepts of stress and stress system disorders: overview of physical and behavioral homeostasis. JAMA. 1992;267(9):1244–1252.
    1. Challis JR, Matthews SG, Gibb W, Lye SJ. Endocrine and paracrine regulation of birth at term and preterm. Endocr Rev. 2000;21(5):514–550.
    1. Tyson EK, Smith R, Read M. Evidence that corticotropin-releasing hormone modulates myometrial contractility during human pregnancy. Endocrinology. 2009;150(12):5617–5625.
    1. Hobel CJ, Dunkel-Schetter C, Roesch SC, Castro LC, Arora CP. Maternal plasma corticotropin-releasing hormone associated with stress at 20 weeks’ gestation in pregnancies ending in preterm delivery. Am J Obstet Gynecol. 1999;180(1):S257–SS63.
    1. Ruiz RJ, Dolbier CL, Fleschler R. The relationships among acculturation, biobehavioral risk, stress, corticotropin-releasing hormone, and poor birth outcomes in Hispanic women. Ethn Dis. 2006;16(4):926.
    1. Ruiz RJ, Gennaro S, O’Connor C, Dwivedi A, Gibeau A, Keshinover T, et al. CRH as a predictor of preterm birth in minority women. Biolog Res Nurs. 2016;18(3):316–321.
    1. Lockwood CJ, Kuczynski E. Risk stratification and pathological mechanisms in preterm delivery. Paediatr Perinat Epidemiol. 2001;15:78–89.
    1. Vannuccini S, Bocchi C, Severi FM, Challis JR, Petraglia F. Endocrinology of human parturition. Annales d’Endocrinologie. Elsevier; 2016.
    1. Ruiz RJ, Marti CN, Pickler R, Murphey C, Wommack J, Brown CE. Acculturation, depressive symptoms, estriol, progesterone, and preterm birth in Hispanic women. Arch Women’s Ment Health. 2012;15(1):57–67.
    1. Ruiz RJ, Dwivedi AK, Mallawaarachichi I, Balcazar HG, Stowe RP, Ayers KS, et al. Psychological, cultural and neuroendocrine profiles of risk for preterm birth. BMC Pregnancy Childbirth. 2015;15(1):1–9.
    1. Ruiz RJ, Newman M, Suchting R, Pasillas RM, Records K, Stowe RP, et al. Pregnant Mexican American biopsychosocial/cultural risks for adverse infant outcomes. Nurs Open. 2021;8(2):709–720.
    1. Rodriguez N, Mira CB, Paez ND, Myers HF. Exploring the complexities of familism and acculturation: central constructs for people of Mexican origin. Am J Community Psychol. 2007;39(1):61–77.
    1. Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385–401.
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097.
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983;24:385–396.
    1. Carver CS. You want to measure coping but your protocol is too long: consider the brief cope. Int J Behav Med. 1997;4(1):92–100.
    1. Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, et al. Preliminary psychometric properties of the acceptance and action questionnaire-II: a revised measure of psychological flexibility and experiential avoidance. Behav Ther. 2011;42(4):676–688.
    1. Mackenzie KR. In: The clinical application of a group climate measure. RDKRM, editor. New York: International Universities Press; 1983.
    1. Williams DR, Yu Y, Jackson JS, Anderson NB. Racial differences in physical and mental health: socioeconomic status, stress, and discrimination. J Health Psychol. 1997;2(3):335–351.
    1. Smith RS, Smith JI, Shen X, Engel PJ, Bowman ME, McGrath SA, Bisits AM, McElduff P, Giles WB, Smith D. Patterns of plasma Corticotropin-releasing hormone, progesterone, estradiol, and Estriol change and the onset of human labor. J Clin Endocrinol Metab. 2009;94(6):2066–2074.
    1. Espel EV, Glynn LM, Sandman CA, Davie EP. Longer gestation among children born full term influences cognitive and motor development. Plos One. 2014;9:e113758.
    1. Sandman CA, Glynn LM, Davis EP. Is there a viability-vulnerability tradeoff? Sex differences in fetal programming. J Psychosom Res. 2013;75:327–335.
    1. DiPietro JA, Voegtline KM. The gestational foundation of sex difference in development and vulnerability. Neurosci Biobehav Rev. 2015:07.068.
    1. McCracken LM, Sato A, Taylor GJ. A trial of a brief group-based acceptance and commitment therapy (ACT) for chronic pain in general practice: pilot outcome and process results. J Pain. 2013;14(11):1398–1406.
    1. Majumdar S, Morris R. Brief group-based acceptance and commitment therapy for stroke survivors. Br J Clin Psychol. 2019;58(1):70–90.
    1. West R. Using Bayesian analysis for hypothesis testing in addiction science. Addiction. 2016;111:3–4.
    1. Gelman A, Carlin JB, Stern HS, Dunson DB, Vehtari A, Rubin DB. Bayesian Data Analysis. 3 2013.
    1. March of Dimes Peristats Data 2022. Preterm Birth Overview | PeriStats | March of Dimes.

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