Szigeti F Judit, Kazinczi Csaba, Szabó Georgina, Sipos Miklós, Ujma Péter Przemyslaw, Purebl György
Institute of Behavioural Sciences, Semmelweis University, Budapest, Hungary.
Department of Otorhinolaryngology, Head and Neck Surgery, Semmelweis University, Budapest, Hungary.
Hum Reprod. 2024 Aug 1;39(8):1735-1751. doi: 10.1093/humrep/deae119.
Does the Mind/Body Program for Infertility (MBPI) perform better, due to certain distinctive elements, than a partly matched support group in improving the wellbeing and medically assisted reproduction (MAR) outcomes of women with elevated distress levels in a clinical setting?
While robust enhancements occurred in the wellbeing overall, the cognitive behavioural and formalized stress management elements of the MBPI allowed a significantly stronger improvement in trait anxiety, but not in other mental health and MAR outcomes, compared with a support group.
Mind-body psychological programmes adjacent to MAR have been found to improve women's mental states and possibly increase chances of pregnancy. However, not enough is known about the programme's effectiveness among patients with elevated distress levels in routine clinical settings, nor is it clear which of its particular ingredients are specifically effective.
STUDY DESIGN, SIZE, DURATION: A pre-post design, single-centre, randomized controlled trial was performed between December 2019 and October 2022 (start and end of recruitment, respectively). The sample size (n = 168) was calculated to detect superiority of the MBPI in improving fertility-related quality of life. Randomization was computer-based, with random numbers concealing identities of patients until after allocation.
PARTICIPANTS/MATERIALS, SETTING, METHODS: The trial was conducted at a large university teaching hospital. A total of 168 patients were randomly assigned to the mind-body (MBPI) group (n = 84) and the fertility support (FS) control group (n = 84). Patients received a 10-week, 135-min/week group intervention, with the FS group following the same format as the MBPI group, but with a less restricted and systematic content, and without the presumed effective factors. The number of patients analysed was n = 74 (MBPI) and n = 68 (FS) for post-intervention psychological outcomes, and n = 54 (MBPI) and n = 56 (FS) for pregnancy outcomes at a 30-month follow-up.
Significant improvements occurred in both groups in all psychological domains (adjusted P < 0.001), except for treatment-related quality of life. Linear mixed-model regression analysis did not reveal significantly greater pre-post improvements in the MBPI group than in the FS group in fertility-related quality of life (difference in differences (DD) = 4.11 [0.42, 7.80], d = 0.32, adjusted P = 0.124), treatment-related quality of life (DD = -3.08 [-7.72, 1.55], d = -0.20, adjusted P = 0.582), infertility-specific stress (DD = -2.54 [-4.68, 0.41], d = -0.36, adjusted P = 0.105), depression (DD = -1.16 [3.61, 1.29], d = -0.13, adjusted P = 0.708), and general stress (DD = -0.62 [-1.91, 0.68], d = -0.13, adjusted P = 0.708), but it did show a significantly larger improvement in trait anxiety (DD = -3.60 [-6.16, -1.04], d = -0.32, adjusted P = 0.042). Logistic regression showed no group effect on MAR pregnancies, spontaneous pregnancies, or live births.
LIMITATIONS, REASONS FOR CAUTION: The follow-up only covered MAR-related medical outcomes and no psychological variables, and their rates were not equal in the two groups. Biological factors other than age, aetiology, and duration of infertility may have confounded the study results. Loss to follow-up was between 5% and 10%, which may have led to some bias.
The psychologically and medically heterogeneous sample, the normal clinical setting and the low attrition rate all raise the external validity and generalizability of our study. The MBPI works not only in controlled conditions, but also in routine MAR practice, where it can be introduced as a cost-effective, low-intensity psychological intervention, within the framework of stepped care. More studies are needed to further identify its active ingredients.
STUDY FUNDING/COMPETING INTEREST(S): The authors received no financial support for the research, authorship, and/or publication of this article. The authors have no conflict of interest to disclose.
ClinicalTrials.gov NCT04151485.
5 November 2019.
DATE OF FIRST PATIENT’S ENROLMENT: 15 December 2019.
在临床环境中，针对不孕症的身心计划（MBPI）是否因其某些独特元素，在改善痛苦水平较高的女性的幸福感和医学辅助生殖（MAR）结局方面，比部分匹配的支持组表现更好？
虽然总体幸福感有显著提升，但与支持组相比，MBPI的认知行为和形式化压力管理元素使特质焦虑有显著更强的改善，但在其他心理健康和MAR结局方面则不然。
已发现与MAR相关的身心心理计划可改善女性的心理状态，并可能增加怀孕几率。然而，对于该计划在常规临床环境中痛苦水平较高的患者中的有效性了解不足，也不清楚其哪些特定成分具有特别的效果。
研究设计、规模、持续时间：2019年12月至2022年10月（分别为招募开始和结束时间）进行了一项前后设计、单中心、随机对照试验。计算样本量（n = 168）以检测MBPI在改善生育相关生活质量方面的优越性。随机化基于计算机，随机数字在分配前对患者身份保密。
参与者/材料、设置、方法：试验在一家大型大学教学医院进行。总共168名患者被随机分配到身心（MBPI）组（n = 84）和生育支持（FS）对照组（n = 84）。患者接受为期10周、每周135分钟的小组干预，FS组采用与MBPI组相同的形式，但内容限制较少且不系统，且没有假定的有效因素。干预后心理结局的分析患者数量为MBPI组n = 74，FS组n = 68；30个月随访时妊娠结局的分析患者数量为MBPI组n = 54，FS组n = 56。
除治疗相关生活质量外，两组在所有心理领域均有显著改善（校正P < 0.001）。线性混合模型回归分析未显示MBPI组在生育相关生活质量（差异差异（DD）= 4.11 [0.42, 7.80]，d = 0.32，校正P = 0.124）、治疗相关生活质量（DD = -3.08 [-7.72, 1.55]，d = -0.20，校正P = 0.582）、不孕症特异性压力（DD = -2.54 [-4.68, 0.41]，d = -0.36，校正P = 0.105）、抑郁（DD = -1.16 [3.61, 1.29]，d = -0.13，校正P = 0.708）和一般压力（DD = -0.�2 [-1.91, 0.68]，d = -0.13，校正P = 0.708）方面的前后改善显著大于FS组，但在特质焦虑方面确实显示出显著更大的改善（DD = -3.60 [-6.16, -1.04]，d = -0.32，校正P = 0.042）。逻辑回归显示两组对MAR妊娠、自然妊娠或活产无影响。
局限性、谨慎理由：随访仅涵盖与MAR相关的医学结局，未涉及心理变量，且两组的发生率不相等。年龄、病因和不孕持续时间以外的生物学因素可能混淆了研究结果。失访率在5%至10%之间，这可能导致了一些偏差。
心理和医学上异质性的样本、正常的临床环境和低损耗率均提高了我们研究的外部有效性和可推广性。MBPI不仅在受控条件下起作用，而且在常规MAR实践中也起作用，在分级护理框架内，它可作为一种具有成本效益的低强度心理干预引入。需要更多研究进一步确定其有效成分。
研究资金/利益冲突：作者未获得该研究、作者身份和/或本文发表的资金支持。作者无利益冲突需要披露。
ClinicalTrials.gov NCT04151485。
2019年11月5日。
2019年12月15日。
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