PDF(Pubmed)
Abstract：
OBJECTIVE: 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?
CONCLUSIONS: 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.
BACKGROUND: 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.
METHODS: 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.
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.
RESULTS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
BACKGROUND: 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.
BACKGROUND: ClinicalTrials.gov NCT04151485.
UNASSIGNED: 5 November 2019.
UNASSIGNED: 15 December 2019.
CONCLUSIONS: 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.
BACKGROUND: 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.
METHODS: 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.
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.
RESULTS: 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.
CONCLUSIONS: 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.
CONCLUSIONS: 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.
BACKGROUND: 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.
BACKGROUND: ClinicalTrials.gov NCT04151485.
UNASSIGNED: 5 November 2019.
UNASSIGNED: 15 December 2019.
摘要：
目标：不孕症的身心计划（MBPI）是否表现更好，由于某些独特的元素，在改善临床环境中痛苦水平升高的女性的健康和医学辅助生殖（MAR）结局方面，比部分匹配的支持小组要好吗？
结论：虽然总体上改善了健康，MBPI的认知行为和形式化的压力管理元素使特质焦虑的改善显着增强，但在其他心理健康和MAR结果中却没有，与支持小组相比。
背景：已发现与MAR相邻的身心心理计划可以改善女性的精神状态，并可能增加怀孕的机会。然而,在常规临床环境中，对该计划在痛苦水平升高的患者中的有效性知之甚少，也不清楚它的特定成分是特别有效的。
方法：pre-post设计，单中心,随机对照试验于2019年12月至2022年10月进行(招募开始和结束，分别)。计算样本量（n=168）以检测MBPI在改善与生育相关的生活质量方面的优越性。随机化是基于计算机的，随机数字隐藏患者的身份，直到分配后。
方法：该试验在一家大型大学教学医院进行。将168例患者随机分为身心（MBPI）组（n=84）和生育支持（FS）对照组（n=84）。患者接受了10周的治疗，135分钟/周的组干预，FS组的格式与MBPI组相同，但是内容限制和系统较少，没有假定的有效因素。干预后心理结局分析的患者人数为n=74（MBPI）和n=68（FS），在30个月的随访中，妊娠结局n=54（MBPI）和n=56（FS）。
结果：两组在所有心理领域均有显着改善（调整后P<0.001），除了与治疗相关的生活质量。线性混合模型回归分析未显示MBPI组在生育相关生活质量方面的前后改善显着大于FS组（差异差异（DD）=4.11[0.42，7.80]，d=0.32，调整后的P=0.124），治疗相关生活质量（DD=-3.08[-7.72，1.55]，d=-0.20,调整后P=0.582),不孕症特异性应激（DD=-2.54[-4.68，0.41]，d=-0.36，调整后P=0.105），抑郁症(DD=-1.16[3.61，1.29]，d=-0.13，调整后的P=0.708），和一般应力(DD=-0.62[-1.91，0.68]，d=-0.13，调整后的P=0.708），但它确实显示了特质焦虑的显着较大改善（DD=-3.60[-6.16，-1.04]，d=-0.32，调整后P=0.042）。Logistic回归显示对MAR妊娠无群体效应，自发怀孕,或活产。
结论：随访仅涵盖与MAR相关的医疗结果，没有心理变量，两组的比率不相等。年龄以外的生物因素，病因学，和不孕症的持续时间可能混淆了研究结果。随访损失在5%到10%之间，这可能导致了一些偏见。
结论：心理和医学上的异质性样本，正常的临床环境和较低的流失率都提高了我们研究的外部有效性和普遍性。MBPI不仅在受控条件下工作，而且在常规的MAR练习中，在那里它可以作为一个具有成本效益的引入，低强度心理干预，在阶梯式护理的框架内。需要更多的研究来进一步确定其活性成分。
背景：作者没有获得资助，作者身份,和/或本文的出版。作者没有利益冲突要披露。
背景：ClinicalTrials.govNCT04151485。
■2019年11月5日。
■2019年12月15日。
结论：虽然总体上改善了健康，MBPI的认知行为和形式化的压力管理元素使特质焦虑的改善显着增强，但在其他心理健康和MAR结果中却没有，与支持小组相比。
背景：已发现与MAR相邻的身心心理计划可以改善女性的精神状态，并可能增加怀孕的机会。然而,在常规临床环境中，对该计划在痛苦水平升高的患者中的有效性知之甚少，也不清楚它的特定成分是特别有效的。
方法：pre-post设计，单中心,随机对照试验于2019年12月至2022年10月进行(招募开始和结束，分别)。计算样本量（n=168）以检测MBPI在改善与生育相关的生活质量方面的优越性。随机化是基于计算机的，随机数字隐藏患者的身份，直到分配后。
方法：该试验在一家大型大学教学医院进行。将168例患者随机分为身心（MBPI）组（n=84）和生育支持（FS）对照组（n=84）。患者接受了10周的治疗，135分钟/周的组干预，FS组的格式与MBPI组相同，但是内容限制和系统较少，没有假定的有效因素。干预后心理结局分析的患者人数为n=74（MBPI）和n=68（FS），在30个月的随访中，妊娠结局n=54（MBPI）和n=56（FS）。
结果：两组在所有心理领域均有显着改善（调整后P<0.001），除了与治疗相关的生活质量。线性混合模型回归分析未显示MBPI组在生育相关生活质量方面的前后改善显着大于FS组（差异差异（DD）=4.11[0.42，7.80]，d=0.32，调整后的P=0.124），治疗相关生活质量（DD=-3.08[-7.72，1.55]，d=-0.20,调整后P=0.582),不孕症特异性应激（DD=-2.54[-4.68，0.41]，d=-0.36，调整后P=0.105），抑郁症(DD=-1.16[3.61，1.29]，d=-0.13，调整后的P=0.708），和一般应力(DD=-0.62[-1.91，0.68]，d=-0.13，调整后的P=0.708），但它确实显示了特质焦虑的显着较大改善（DD=-3.60[-6.16，-1.04]，d=-0.32，调整后P=0.042）。Logistic回归显示对MAR妊娠无群体效应，自发怀孕,或活产。
结论：随访仅涵盖与MAR相关的医疗结果，没有心理变量，两组的比率不相等。年龄以外的生物因素，病因学，和不孕症的持续时间可能混淆了研究结果。随访损失在5%到10%之间，这可能导致了一些偏见。
结论：心理和医学上的异质性样本，正常的临床环境和较低的流失率都提高了我们研究的外部有效性和普遍性。MBPI不仅在受控条件下工作，而且在常规的MAR练习中，在那里它可以作为一个具有成本效益的引入，低强度心理干预，在阶梯式护理的框架内。需要更多的研究来进一步确定其活性成分。
背景：作者没有获得资助，作者身份,和/或本文的出版。作者没有利益冲突要披露。
背景：ClinicalTrials.govNCT04151485。
■2019年11月5日。
■2019年12月15日。
