Psychological distress during pregnancy is common: up to 20% of the childbearing women experience symptoms of depression and anxiety. Apart from the adverse effects on the woman herself, pregnancy distress can negatively affect pregnancy outcomes, infant health, postpartum mother-child interaction and child development. Therefore, the development of interventions that reduce pregnancy distress is very important. Mindfulness-based interventions (MBIs) show promising positive effects on pregnancy distress, but there is a need for randomized controlled trials with sufficient power. Trials on online MBIs, which are readily accessible and not expensive, also show positive effects on stress reduction in non-pregnant populations. Moreover, specific working mechanisms of MBIs remain unclear. The aim of the current study is to test the effectiveness of an online MBI in pregnant women with pregnancy distress, as well as exploring potential working mechanisms. The current study is a randomized controlled trial with repeated measures. Consenting women with elevated levels of pregnancy distress will be randomized into an intervention group (MBI) or control group (care as usual) around 12 weeks of pregnancy, with an intended sample size of 103 women in each group. The primary outcome, pregnancy distress, will be assessed via questionnaires at baseline, halfway through the intervention and post intervention in both intervention and control group, and after 8 weeks follow-up in the intervention group. Secondary outcomes are mindfulness skills, rumination and self-compassion, which are also seen as potential working mechanisms, and will be assessed via questionnaires before intervention, halfway through the intervention, post intervention and after 8 weeks follow-up in the intervention group. Tertiary outcome variables are obstetric data and will be collected from the obstetric records for both intervention and control group. Analyses will be based on the intention-to-treat principle. Multilevel regression models for repeated measures (mixed models) will be used to evaluate changes in primary and secondary outcome variables. Tertiary outcomes will be compared between groups using independent t-tests and Chi Square analyses. The trial is expected to increase knowledge about the effectiveness of online MBIs during pregnancy in women with pregnancy distress and to evaluate potential working mechanisms. ClinicalTrials.gov: NCT03917745, registered on 4 March 2019. Protocol Version 3.0., 20 February 2020.

中文翻译：

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基于在线正念的妊娠困扰妇女干预：一项随机对照试验的设计

怀孕期间的心理困扰很普遍：多达20％的育龄妇女会出现抑郁和焦虑症状。除了对妇女本身的不利影响外，妊娠困扰还会对妊娠结局，婴儿健康，产后母婴互动和儿童发育产生负面影响。因此，开发减少妊娠困扰的干预措施非常重要。基于正念的干预措施（MBIs）显示出对妊娠困扰的积极作用，但需要具有足够功效的随机对照试验。易于获得且价格不昂贵的在线MBI的试验也显示出对减少非孕妇人群压力的积极作用。此外，MBI的具体工作机制仍不清楚。本研究的目的是测试在线MBI在有怀孕困扰的孕妇中的有效性，并探索潜在的工作机制。当前的研究是一项具有重复措施的随机对照试验。同意的妊娠困扰水平升高的妇女将在妊娠12周左右被随机分为干预组（MBI）或对照组（照常护理），每组的预期样本量为103名妇女。在基线，干预中途和干预后以及干预组和干预后以及干预组进行8周随访后，将通过问卷调查评估主要结局，即妊娠窘迫。次要结果是正念技能，沉思和同情心，这也被视为潜在的工作机制，并在干预前，干预中途，干预后以及干预组8周随访后通过问卷进行评估。第三级结局变量是产科数据，将从干预和对照组的产科记录中收集。分析将基于意向性治疗原则。重复测量的多级回归模型（混合模型）将用于评估主要和次要结果变量的变化。将使用独立的t检验和卡方分析对两组之间的第三级结局进行比较。预计该试验将增加有关妊娠窘迫妇女怀孕期间在线MBI有效性的知识，并评估潜在的工作机制。ClinicalTrials.gov：NCT03917745，于2019年3月4日注册。