在线正念干预对妊娠困扰妇女的影响：一项随机对照试验的设计。
Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial.
机构信息
Center of Research in Psychological and Somatic disorders (CoRPS), Department of Medical and Clinical Psychology, Tilburg University, P.O. BOX 90153, Warandelaan 2, 5000 LE, Tilburg, the Netherlands.
UvA minds, academic outpatient (child and adolescent) treatment center of the University of Amsterdam, Amsterdam, the Netherlands.
出版信息
BMC Pregnancy Childbirth. 2020 Mar 13;20(1):159. doi: 10.1186/s12884-020-2843-0.
BACKGROUND
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.
METHODS
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.
DISCUSSION
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.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03917745, registered on 4 March 2019. Protocol Version 3.0., 20 February 2020.
背景
怀孕期间的心理困扰很常见：高达 20%的育龄妇女出现抑郁和焦虑症状。除了对妇女自身的不利影响外，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）对妊娠困扰显示出有希望的积极效果，但需要进行有足够效力的随机对照试验。针对非怀孕人群的在线 MBIs 试验也显示出减轻压力的积极效果，且这些试验易于获得且费用不高。此外，MBIs 的具体工作机制仍不清楚。本研究的目的是测试在线 MBI 对有妊娠困扰的孕妇的有效性，并探索潜在的工作机制。
方法
本研究是一项随机对照试验，采用重复测量。在妊娠 12 周左右，将有妊娠困扰的孕妇同意者随机分为干预组（MBI）或对照组（常规护理），每组 103 名妇女。主要结局是妊娠困扰，将通过问卷在基线、干预中途和干预后在干预组和对照组中进行评估，并在干预组中进行 8 周随访。次要结局是正念技能、反刍和自我同情，这些也被视为潜在的工作机制，将通过问卷在干预前、干预中途、干预后和干预组的 8 周随访中进行评估。三级结局变量是产科数据，将从干预组和对照组的产科记录中收集。分析将基于意向治疗原则进行。将使用重复测量的多级回归模型（混合模型）来评估主要和次要结局变量的变化。使用独立 t 检验和卡方分析比较组间的三级结局。
讨论
该试验有望增加关于在线 MBIs 在有妊娠困扰的孕妇中的有效性的知识，并评估潜在的工作机制。
试验注册
ClinicalTrials.gov：NCT03917745，于 2019 年 3 月 4 日注册。方案版本 3.0，2020 年 2 月 20 日。
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