Skovbjerg Sine, Kolls Michelle, Kjærbye-Thygesen Anette, Fjorback Lone Overby
The Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Department of Obstetrics and Gynaecology, Copenhagen University Hospital, Amager and Hvidovre, Hvidovre, Denmark.
Pilot Feasibility Stud. 2025 Jun 21;11(1):86. doi: 10.1186/s40814-025-01670-0.
Supporting prenatal mental health in women with a preconception history of mental disorders or psychosocial vulnerability is important for a positive transition to parenthood. There is a need for more evidence-based and non-pharmacological mental health interventions in antenatal care. The primary objective of this trial was to evaluate the feasibility of prenatal MBSR, which is an adaption of Mindfulness-based stress reduction (MBSR). This to inform a randomized controlled trial.
METHODS/DESIGN: The trial was conducted at an obstetric outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark. The outpatient clinic specializes in antenatal care for pregnant women with psychosocial vulnerabilities. Pregnant women were randomly assigned to an intervention group receiving prenatal MBSR or a waitlist control group. The primary outcome was the feasibility of a full-scale randomized controlled trial (RCT). Second, to examine trends in self-reported outcomes, i.e., mental well-being, perceived stress, anxiety, depression, decentering, reflective functioning, mindfulness, and self-compassion.
Of 123 eligible women, 73 consented to participate (59.3%). The majority (75.3%) were nulliparous. The mean age was 30.7 (SD 4.7) years, and most participants were employed (74%) and living with a partner (93.1%) at the time of recruitment. The majority of participants had a history of one or more mental disorders. Most frequently depression or an anxiety disorder. For the intervention group (n = 37), 54.1% completed the prenatal MBSR program. The loss to follow-up was 56.8% for the intervention group (n = 21) and 50% for the waitlist control group (n = 18). For the secondary outcomes, all variables except for reflective functioning pointed in the expected direction, e.g., improved mental well-being, reduced mental distress, and more self-compassion.
The results from this trial suggest that prenatal MBSR is a feasible intervention for a clinical setting, supporting the conduct of an RCT. Strategies for improving adherence and reducing the extent of missing data would be advisable in a future RCT. Overall, there is a need for more evidence-based and non-pharmacological interventions addressing prenatal mental health. Results from a future RCT could thus be of relevance to antenatal care.
NCT04571190, September 30, 2020 (ClinicalTrials.gov).
对于有孕前精神障碍病史或心理社会脆弱性的女性，支持其孕期心理健康对于向为人父母的积极过渡至关重要。产前护理中需要更多基于证据的非药物心理健康干预措施。本试验的主要目的是评估产前正念减压疗法（MBSR）的可行性，该疗法是基于正念减压疗法（MBSR）改编而来。以此为随机对照试验提供信息。
方法/设计：该试验在丹麦哥本哈根大学医院阿迈厄和维德沃勒分院的产科门诊进行。该门诊专门为有心理社会脆弱性的孕妇提供产前护理。孕妇被随机分配到接受产前MBSR的干预组或等待名单对照组。主要结果是全面随机对照试验（RCT）的可行性。其次，研究自我报告结果的趋势，即心理健康、感知压力、焦虑、抑郁、去中心化、反思功能、正念和自我同情。
在123名符合条件的女性中，73人同意参与（59.3%）。大多数（75.3%）为初产妇。平均年龄为30.7岁（标准差4.7），大多数参与者在招募时已就业（74%）且与伴侣同住（93.1%）。大多数参与者有过一种或多种精神障碍病史。最常见的是抑郁症或焦虑症。干预组（n = 37）中，54.1%完成了产前MBSR项目。干预组的失访率为56.8%（n = 21），等待名单对照组为50%（n = 18）。对于次要结果，除反思功能外，所有变量均指向预期方向，例如心理健康改善、心理困扰减轻和更多自我同情。
该试验结果表明，产前MBSR在临床环境中是一种可行的干预措施，支持进行随机对照试验。在未来的随机对照试验中，建议采取提高依从性和减少数据缺失程度的策略。总体而言，需要更多基于证据的非药物干预措施来解决产前心理健康问题。未来随机对照试验的结果可能与产前护理相关。
NCT04571190，2020年9月30日（ClinicalTrials.gov）
