Sacristan-Martin Olga, Santed Miguel A, Garcia-Campayo Javier, Duncan Larissa G, Bardacke Nancy, Fernandez-Alonso Carmen, Garcia-Sacristan Gloria, Garcia-Sacristan Diana, Barcelo-Soler Alberto, Montero-Marin Jesus
Primary Care Prevention and Health Promotion Research Network (RedIAPP), Valladolid, Spain.
International School of Doctorate Studies, National University of Distance Education (UNED), Madrid, Spain.
Trials. 2019 Nov 28;20(1):654. doi: 10.1186/s13063-019-3739-z.
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.
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.
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.
ClinicalTrials.gov, NCT03247491. Registered on 31 July 2017.
怀孕和产后时期对女性及其伴侣来说是发生巨大变化的时期，常常带来诸多重大挑战和压力。约10%-20%的女性在围产期患有抑郁症等情绪障碍。使用精神药物干预治疗围产期抑郁症存在风险。基于正念和同情心的教育项目可能是预防和治疗围产期情绪障碍的有效且具成本效益的选择。本研究的目的是评估一种经过改编的基于正念的分娩与育儿（MBCP）项目的疗效，该项目在西班牙国家卫生系统的初级保健（PC）环境中为孕妇提供同情心训练，以减少围产期抑郁症。
将开展一项多中心随机对照试验（RCT）。参与者将是希望参与的孕妇（n = 122）及其伴侣。他们将在初级保健环境中登记并接受评估，然后随机分配到以下两组之一：（1）针对西班牙国家卫生系统改编的MBCP教育项目 + 常规治疗（TAU）；或（2）仅接受常规治疗。待评估的主要结局将是抑郁症，使用爱丁堡产后抑郁量表（EPDS）进行评估。次要结局将包括自我报告的感知压力、情感、正念、自我同情、母亲自我效能以及健康和社会服务的使用情况。患者将在四个时间点接受评估：基线；治疗后；产后三个月和六个月。将使用线性回归混合模型进行意向性分析和符合方案分析。效应量将使用科恩d值进行估计。
围产期抑郁症是一个重大的健康问题。一个纳入正念和同情心练习的有效且低成本的分娩教育项目可能是为准妈妈及其伴侣提供有益预防作用的补充医疗保健方式。本研究将是西班牙初级保健环境中首个使用改编后的MBCP和同情心练习来减轻孕期和产后抑郁症状的多中心随机对照试验。
ClinicalTrials.gov，NCT03247491。于2017年7月31日注册。
