Woolhouse Hannah, Mercuri Kristine, Judd Fiona, Brown Stephanie J
BMC Pregnancy Childbirth. 2014 Oct 25;14:369. doi: 10.1186/s12884-014-0369-z.
Mindfulness interventions to reduce psychological distress are well-suited to pregnancy, due to their brief and non-pharmacological nature, but there is a need for more robust evidence determining their usefulness. This pilot study was designed to explore the feasibility of a randomised controlled trial of a mindfulness intervention to reduce antenatal depression, anxiety and stress.
The study was designed in two parts 1) a non-randomised trial targeting women at risk of mental health problems (a selected population) and 2) a randomised controlled trial (RCT) of a universal population. Process evaluation focused on feasibility of recruitment pathways, participant retention, acceptability of study measures, and engagement with mindfulness practices. Measurement of psychological distress was taken pre and post intervention through the Centre for Epidemiologic Studies Depression Scale Revised, the Depression Anxiety and Stress Scale-21, the State-Trait Anxiety Inventory, and the Perceived Stress Scale.
20 women were recruited to the non-randomised trial, and 32 to the RCT. Recruitment through a mailed study brochure at the time of booking-in to the hospital resulted in the largest number of participants in the RCT (16/32; 50%), and resulted in considerably earlier recruitment (50% in first trimester, 50% second trimester) compared to recruitment through the antenatal clinic waiting room (86% in second trimester, 14% third trimester). Over a third of women in the universal population scored above clinical cut-offs for depression and anxiety, indicating a sample with more symptomology than the general population. The most common reason for loss to follow-up was delivery of baby prior to follow-up (n = 9). In the non-randomised study, significant within group improvements to depression and anxiety were observed. In the intervention arm of the RCT there were significant within group improvements to anxiety and mindfulness. No between group differences for the intervention and 'care as usual' control group were observed.
This small pilot study provides evidence on the feasibility of an antenatal mindfulness intervention to reduce psychological distress. Major challenges include: finding ways to facilitate recruitment in early pregnancy and engaging younger women and other vulnerable populations.
Australian New Zealand Clinical Trials Registry ACTRN12613000742774 (31/10/2012).
正念干预因其简短且非药物的特性,非常适合用于孕期以减轻心理困扰,但仍需要更有力的证据来确定其有效性。这项试点研究旨在探索一项正念干预随机对照试验的可行性,该试验旨在减轻产前抑郁、焦虑和压力。
该研究分为两个部分设计:1)针对有心理健康问题风险的女性(特定人群)的非随机试验,以及2)针对普通人群的随机对照试验(RCT)。过程评估聚焦于招募途径的可行性、参与者留存率、研究措施的可接受性以及对正念练习的参与度。通过修订的流行病学研究中心抑郁量表、抑郁焦虑压力量表 -21、状态 - 特质焦虑量表和感知压力量表在干预前后对心理困扰进行测量。
20名女性被招募到非随机试验中,32名被招募到随机对照试验中。在入院登记时通过邮寄研究手册进行招募,使得随机对照试验中的参与者数量最多(16/32;50%),并且与通过产前诊所候诊室招募相比,招募时间更早(孕早期50%,孕中期50%),而通过产前诊所候诊室招募的情况是(孕中期86%,孕晚期14%)。普通人群中超过三分之一的女性抑郁和焦虑得分高于临床临界值,这表明该样本的症状比一般人群更多。失访的最常见原因是在随访前分娩(n = 9)。在非随机研究中,观察到组内抑郁和焦虑有显著改善。在随机对照试验的干预组中,焦虑和正念方面组内有显著改善。未观察到干预组与“常规护理”对照组之间的组间差异。
这项小型试点研究为产前正念干预减轻心理困扰的可行性提供了证据。主要挑战包括:找到促进孕早期招募的方法,以及吸引年轻女性和其他弱势群体参与。
澳大利亚新西兰临床试验注册中心ACTRN12613000742774(2012年10月31日)。