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Open Access 01-12-2019 | Affective Disorder | Study protocol

A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial

Authors: Olga Sacristan-Martin, Miguel A. Santed, Javier Garcia-Campayo, Larissa G. Duncan, Nancy Bardacke, Carmen Fernandez-Alonso, Gloria Garcia-Sacristan, Diana Garcia-Sacristan, Alberto Barcelo-Soler, Jesus Montero-Marin

Published in: Trials | Issue 1/2019

Abstract

Background

Pregnancy and the postpartum period are times of great change for women and their partners, often bringing substantial challenges and stress. Approximately 10%–20% of women suffer from mood disorders such as depression in the perinatal period. There are risks involved in using psychopharmacological interventions to treat perinatal depression. Mindfulness and compassion-based educational programs could be efficacious and cost-effective options for the prevention and treatment of perinatal mood disorders. The aim of this study is to assess the efficacy of an adapted Mindfulness-Based Childbirth and Parenting (MBCP) program that includes compassion training for pregnant women in primary care (PC) settings in the Spanish National Health System to decrease perinatal depression.

Methods

A multicenter randomized controlled trial (RCT) will be conducted. Participants will be pregnant women (n = 122) and their partners who wish to participate. They will be enrolled and assessed in PC settings and randomly assigned to either: (1) an adapted MBCP educational program tailored to the Spanish National Health System + treatment as usual (TAU); or (2) TAU only. The main outcome to be assessed will be depression, evaluated with the Edinburgh Postnatal Depression Scale (EPDS). Secondary outcomes will include self-reported measures of perceived stress, affects, mindfulness, self-compassion, maternal self-efficacy, and use of health and social services. Patients will be assessed at four timepoints: baseline; post-treatment; and at three and six months after childbirth. Intention-to-treat and per-protocol analyses will be carried out using linear regression mixed models. Effect sizes will be estimated using Cohen’s d.

Discussion

Perinatal depression is a significant health problem. An effective and low-cost childbirth education program that incorporates mindfulness and compassion practices may be a beneficial preventive complementary healthcare modality for expectant women and their partners. This study will be the first multicenter RCT in Spanish PC settings using adapted MBCP and compassion practices to reduce symptoms of depression during pregnancy and the postpartum period.

Trial registration

ClinicalTrials.gov, NCT03247491. Registered on 31 July 2017.

Available only for authorised users

Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005;106(5):1071–83.PubMed

Krauss P, Lovisi GM, Abelha L, Fortes L, Fernandes J, Agadir S, et al. Depression during pregnancy: review of epidemiological and clinical aspects in developed and developing countries. Psychiatr Disord Trends Dev. https://www.intechopen.com/books/psychiatric-disorders-trends-and-developments/depression-during-pregnancy-review-of-epidemiological-and-clinical-aspects-in-developed-and-developi. Accessed 14 Mar 2019.

American College of Obstetrician and Gynecologist. Screening for perinatal depression. Obstet Gynecol. 2015;125:1268–71.

Field T. Prenatal depression effects on early development: a review. Infant Behav Dev. 2011;34:1–14. https://doi.org/10.1016/j.infbeh.2010.09.008.PubMed

Wisner KL, Chambers C, Sit DK. Postpartum depression: a major public health problem. JAMA. 2006;296(21):2616–8.PubMed

National Institute for Health and Care Excellence. Antenatal and postnatal mental health. https://www.nice.org.uk/guidance/cg192/evidence/full-guideline-pdf-4840896925. Accessed 12 Mar 2019.

Rodríguez-Muñoz M, Le HN, de la Cruz IV, Crespo MEO, Méndez NI. Feasibility of screening and prevalence of prenatal depression in an obstetric setting in Spain. Eur J Obstet Gynecol Reprod Biol. 2017;215:101–5.

Da Costa D, Zelkowitz P, Letourneau N, et al. What do men want in a website designed to promote emotional wellness and healthy behaviors during the transition to parenthood? J Med Internet Res. 2017;19(10):325. https://doi.org/10.2196/jmir.7415.CrossRef

Warriner S, Crane C, Dymond M, Dymond M, Krusche A. An evaluation of mindfulness-based childbirth and parenting courses for pregnant women and prospective fathers/partners within the UK NHS (MBCP-4-NHS). Midwifery. 2018;64:1–10. https://doi.org/10.1016/j.midw.2018.05.004.CrossRefPubMed

10.

Norhayati MN, Hazlina NH, Asrenee AR, Emilin WM. Magnitude and risk factors for postpartum symptoms: a literature review. J Affect Disord. 2015;1(175):34–52. https://doi.org/10.1016/j.jad.2014.12.041.CrossRef

11.

Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004;26(4):289–95.PubMed

12.

O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379–407. https://doi.org/10.1146/annurev-clinpsy-050212-185612.CrossRefPubMed

13.

Perfetti J, Clark R, Fillmore CM. Postpartum depression: identification, screening, and treatment. Wis Med J. 2004;103:56–63.

14.

Garcia-Esteve L, Giménez AT, Gurrutxaga IML, García PN, Terrén CA, Gelabert E. Maternity, migration, and mental health: comparison between Spanish and Latina immigrant mothers in postpartum depression and health behaviors. In: Lara-Cinisomo S, Wisner K, editors. Perinatal depression among Spanish- speaking and Latin American women. New York: Springer; 2014. p. 15–37.

15.

Sorenson DL. Uncertainty in pregnancy. NAACOGS Clin Issu Perinat Womens Health Nurs. 1990;1(3):289–96.PubMed

16.

Newport DJ, Hostetter AL, Juul SH, Porterfield SM, Knight BT, Stowe ZN. Prenatal psychostimulant and antidepressant exposure and risk of hypertensive disorders of pregnancy. J Clin Psychiatry. 2016;77(11):1538–45.PubMed

17.

Conley CS, Shapiro JB, Kirsch AC, Durlak JA. A meta-analysis of indicated mental health prevention programs for at-risk higher education students. J Couns Psychol. 2017;64(2):121.PubMed

18.

Feldman C, Kuyken W. Compassion in the landscape of suffering. Contemp Buddhism. 2011;12:143–55.

19.

MacBeth A, Gumley A. Exploring compassion: a meta-analysis of the association between self-compassion and psychopathology. Clin Psychol Rev. 2012;32:545–52. https://doi.org/10.1016/j.cpr.2012.06.003.CrossRefPubMed

20.

Hollis-Walker L, Colosimo K. Mindfulness, self-compassion, and happiness in non-meditators: A theoretical and empirical examination. Pers Individ Dif. 2011;50(2):222–7.

21.

Goldberg SB, Tucker RP, Greene PA, Davidson RJ, Wampold BE, Kearney DJ, et al. Mindfulness-based interventions for psychiatric disorders: a systematic review and meta-analysis. Clin Psychol Rev. 2018;59:52–60.PubMed

22.

Hofmann S, Sawyer AT, Wit AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: a meta-analysis. J Psychosom Res. 2010;57:35–43.

23.

Nyklíček I, Truijens SEM, Spek V, Pop VJM, Sophie EM. Mindfulness skills during pregnancy: prospective associations with mother's mood and neonatal birth weight. J Psychosom Res. 2018;107:14–9. https://doi.org/10.1016/j.jpsychores.2018.01.012.CrossRefPubMed

24.

Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017;17:140. https://doi.org/10.1186/s12884-017-1319-3.CrossRefPubMedPubMedCentral

25.

Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982;4(1):33–47.PubMed

26.

Kabat-Zinn J, Lipworth L, Burney R. The clinical use of mindfulness meditation for the self-regulation of chronic pain. J Behav Med. 1985;8(2):163–90.PubMed

27.

Kingston J, Chadwick P, Meron D, Skinner TC. A pilot randomized control trial investigating the effect of mindfulness practice on pain tolerance, psychological well-being, and physiological activity. J Psychosom Res. 2007;62(3):297–300.PubMed

28.

Zeidan F, Gordon NS, Merchant J, Goolkasian P. The effects of brief mindfulness meditation training on experimentally induced pain. J Pain. 2010;11(3):199–209.PubMed

29.

Dimidjian S, Goodman SH. Preferences and attitudes toward approaches to depression relapse/recurrence prevention among pregnant women. Behav Res Ther. 2014;54:7–11.PubMed

30.

Koehn M. Contemporary women’s perceptions of childbirth education. J Perinat Educ. 2008;17(1):11–8.PubMedPubMedCentral

31.

Haakstad LA, Voldner N, Bø K. Stages of change model for participation in physical activity during pregnancy. J Pregnancy. 2013;2013:193170. https://doi.org/10.1155/2013/193170.CrossRefPubMedPubMedCentral

32.

Vieten C, Astin J. Effects of a mindfulness-based intervention during pregnancy on prenatal stress and mood: results of a pilot study. Arch Womens Ment Health. 2008;11(1):67–74. https://doi.org/10.1007/s00737-008-0214-3.CrossRefPubMed

33.

Byrne J, Hauck Y, Fisher C, Bayes S, Schutze R. Effectiveness of a mindfulness – based childbirth education pilot study on maternal self-efficacy and fear of childbirth. J Mildwifery Womens Health. 2014;59(2):192–7.

34.

Woolhouse H, Mercuri K, Judd F, Brown SJ. Antenatal mindfulness intervention to reduce depression, anxiety and stress: a pilot randomised controlled trial of the MindBabyBody program in an Australian tertiary maternity hospital. BMC Pregnancy Childbirth. 2014;14:369. https://doi.org/10.1186/s12884-014-0369-z.CrossRefPubMedPubMedCentral

35.

Duncan LG, Bardacke N. Mindfulness-based childbirth and parenting education: promoting family mindfulness during the perinatal period. J Child Fam Stud. 2010;19(2):190–202. https://doi.org/10.1007/s10826-009-9313-7.CrossRefPubMed

36.

Veringa IK, de Bruin EI, Bardacke N, Duncan LG, van Steensel FJ, Dirksen CD, et al. I’ve changed my mind. Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial. BMC Psychiatry. 2016;16:377. https://doi.org/10.1186/s12888-016-1070.CrossRefPubMedPubMedCentral

37.

Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: a pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2015;84(2):134–45.PubMedPubMedCentral

38.

Goodman JH, Guarino AJ, Chenausky K, Klein L, Prager J, Petersen R, et al. Calm pregnancy: results of a pilot study of mindfulness-based cognitive therapy for perinatal anxiety. Arch Womens Ment Health. 2014;17(5):373–87. https://doi.org/10.1007/s00737-013-0402-7.CrossRefPubMedPubMedCentral

39.

Luberto CM, Park ER, Goodman JH. Postpartum outcomes and formal mindfulness practice in mindfulness-based cognitive therapy for perinatal women. Midwifery. 2018;64:1–10.

40.

Cree M. The compassionate mind approach to postnatal depression. London: Robinson; 2015.

41.

Kelman AR, Stanley ML, Barrera AZ, Cree M, Heineberg Y, Gilbert P. Comparing brief internet-based compassionate mind training and cognitive behavioral therapy for perinatal women: study protocol for a randomized controlled trial. JMIR Res Protoc. 2016;5(2):e65. https://doi.org/10.2196/resprot.5332.CrossRefPubMedPubMedCentral

42.

Statistics National Institute (2018). Birth statistics: births occurred in Spain (2017). https://www.ine.es/dyngs/INEbase/es/operacion.htm?c=Estadistica_C&cid=1254736177007&menu=ultiDatos&idp=1254735573002. Accessed 12 Mar 2019.

43.

Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.PubMedPubMedCentral

44.

Dhillon A, Sparkes E, Duarte RV. Mindfulness-based interventions during pregnancy: a systematic review and meta-analysis. Mindfulness. 2017;8(6):1421–37. https://doi.org/10.1007/s12671-017-0726-x.CrossRefPubMedPubMedCentral

45.

Lever Taylor B, Cavanagh K, Strauss C. The effectiveness of mindfulness-based interventions in the perinatal period: a systematic review and meta-analysis. PLoS One. 2016;11(5):e0155720. https://doi.org/10.1371/journal.pone.0155720.CrossRefPubMedPubMedCentral

46.

Ferrando L, Franco L, Soto M, Bobes J, Soto O, Franco-Alfonso L, et al. MINI international neuropsychiatric interview. Versión en español 5.0.0. Madrid: IAP; 1998.

47.

Bardacke N. Mindful birthing: training the mind, body, and heart for childbirth and beyond. New York: HarperOne; 2012.

48.

Kantrowitz-Gordon I, Abbott S, Hoehn R. Experiences of postpartum women after mindfulness childbirth classes: a qualitative study. J Midwifery Womens Health. 2018;63(4):462–9. https://doi.org/10.1111/jmwh.12734.CrossRefPubMed

49.

Cox J, Holden J, Sagovsky R. Detection of postnatal depression: development of the10-item Edinburgh postnatal depression scale. Br J Psychiatry. 1987;150(6):782–6. https://doi.org/10.1192/bjp.150.6.782.CrossRefPubMed

50.

Cox JL, Chapman G, Murray D, Jones P. Validation of the Edinburgh Postnatal Depression Scale (EPDS) in non-postnatal women. J Affect Disord. 1996;39(3):185–9.PubMed

51.

Garcia-Esteve L, Ascaso C, Ojuel J, Navarro P. Validation of the Edinburgh Postnatal Depression Scale (EPDS) in Spanish mothers. J Affect Disord. 2003;75(1):71–6.PubMed

52.

Cohen S, Kamarck T, Mermelstein R. A Global measure of perceived stress. J Health Soc Behav. 1983;24(4):385–96.PubMed

53.

Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006;9(1):86–93.PubMed

54.

Watson D, Clark L, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54:1063–70.PubMed

55.

Sandín B, Chorot P, Lostao L, Joiner TE, Santed MA, Valiente RM. Escalas panas de afecto positivo y negativo: Validación factorial y convergencia transcultural. Psicothema. 1999;11(1):37–51.

56.

Baer R, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment to explore facets of mindfulness. Assessment. 2006;13:27–45.PubMed

57.

Aguado J, Luciano JV, Cebolla A, Serrano-Blanco A, Soler J, García-Campayo J. Bifactor analysis and construct validity of the five facet mindfulness questionnaire (FFMQ) in non-clinical Spanish samples. Front Psychol. 2015;6:404.PubMedPubMedCentral

58.

Neff KD. The development and validation of a scale to measure self-compassion. Self Identity. 2003;2(3):223–50.

59.

Neff KD, Tóth-Király I, Yarnell LM, Arimitsu K, Castilho P, Ghorbani N, et al. Examining the factor structure of the Self-Compassion Scale in 20 diverse samples: support for use of a total score and six subscales scores. Psychol Asses. 2018;31(1):27–45. https://doi.org/10.1037/pas0000629.CrossRef

60.

Garcia-Campayo J, Navarro-Gil M, Andrés E, Montero-Marin J, López-Artal L, Demarzo MMP. Validation of the Spanish versions of the long (26 items) and short (12 items) forms of the self-compassion scale (SCS). Health Qual Life Outcomes. 2014;12:4. https://doi.org/10.1186/1477-7525-12-4.CrossRefPubMedPubMedCentral

61.

Farkas-Klein C. Escala de evaluación parental (EEP): desarrollo, propiedades psicométricas y aplicaciones. Univ Psychol. 2008;7(2):457–67.

62.

Beecham JK, Knapp MRJ. Costing psychiatric interventions. In: Thornicroft G, editor. Measuring mental health needs. London: Royal College of Psychiatrists; 2001. p. 200–24.

63.

Vazquez-Barquero JL, Gaite L, Cuesta MJ, Garcia-Usieto E, Knapp M, Beecham J. Spanish version of the CSRI: a mental health cost evaluation interview. Arch Neurobiol. 1997;60:171–84.

64.

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche, Devereaux PJ, et al. ConSoRT 2010. Explanation and elaboration: updated guidelines for reporting parallel group randomized trials. BMJ. 2010;340:c869. https://doi.org/10.1136/bmj.c869.CrossRefPubMedPubMedCentral

65.

Gu J, Strauss C, Bond R, Cavanagh K. How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies. Clin Psychol Rev. 2015;37:1–12.PubMed

66.

White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011;30(4):377–99.PubMed

67.

Morris S. Estimating effect sizes from pretest-posttest-control group designs. Organ Res Meth. 2008;11(2):364–86.

68.

Kuyken W, Warren FC, Taylor RS, Whalley B, Crane C, Bondolfi G, et al. Efficacy of mindfulness-based cognitive therapy in prevention of depressive relapse: an individual patient data meta-analysis from randomized trials. JAMA Psychiatry. 2016;73(6):565–74.PubMed

69.

Kabat-Zinn J, Chapman-Waldrop A. Compliance with an outpatient stress reduction program: rates and predictors of program completion. J Behav Med. 1988;11(4):333–52.PubMed

70.

Hughes A, Williams M, Bardacke N, Duncan LG, Dimidjian S, Goodman SH. Mindfulness approaches to childbirth and parenting. Br J Midwifery. 2009;17(10):630–5.PubMedPubMedCentral

Title: A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial
Authors: Olga Sacristan-Martin
Miguel A. Santed
Javier Garcia-Campayo
Larissa G. Duncan
Nancy Bardacke
Carmen Fernandez-Alonso
Gloria Garcia-Sacristan
Diana Garcia-Sacristan
Alberto Barcelo-Soler
Jesus Montero-Marin
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Affective Disorder
Postpartum Depression
Postpartum Depression
Affective Disorder
Published in: Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-019-3739-z

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A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial

Abstract

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Methods

Discussion

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Abstract

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