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

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, 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

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.

Keywords: Childbirth; Compassion; Mindfulness; Perinatal and postpartum depression; RCT; Stress in pregnancy.

Conflict of interest statement

NB is the developer of MBCP and leads the not-for-profit Mindful Birthing and Parenting Foundation (MBPF) that offers professional training in MBCP. She is the author of a related book and app/guided audio meditation materials for which she receives royalties. LGD is an unpaid member of the MBPF board of directors and is conducting other Institutional Review Board approved research on MBCP funded by the Mind & Life Institute. The other authors declare they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Schedule of enrolment, interventions, and assessment

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