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一项在线心理健康干预措施在孕妇及其伴侣中应用的可行性和可接受性:一项混合方法研究,包含一项先导随机对照试验。

Feasibility and acceptability of an online mental health intervention for pregnant women and their partners: a mixed method study with a pilot randomized control trial.

机构信息

Department of Family and Community Medicine, University of Missouri, Columbia, MO, USA.

School of Social Work, University of Missouri, Columbia, MO, USA.

出版信息

BMC Pregnancy Childbirth. 2023 Oct 18;23(1):739. doi: 10.1186/s12884-023-06031-4.

Abstract

BACKGROUND

Untreated perinatal mood and anxiety disorders (PMAD) have short- and long-term health and social consequences; online cognitive behavioral therapy (CBT) interventions can reduce symptoms. Despite partner support being protective online interventions rarely target couples. This study builds on research on an existing CBT-based intervention, the Mothers and Babies Online Course (eMB), by testing its feasibility with prenatal couples.

METHODS

We conducted a pilot, randomized, controlled feasibility trial using a 1:1 parallel design. To be eligible, participant dyads were pregnant people (between 13-30 weeks gestation and with a score of 10 or greater on either the GAD-7 or PHQ-9 scale indicating elevated symptoms of anxiety or depression) and their cohabitating partners, living in Missouri, with access to the internet; both in the dyad consented to participate. Recruitment occurred via Facebook ads, flyers, and a snowball approach. The intervention group received eMB, and the control group received a list of community resources. We examined retention and adherence data extracted from eMB analytics and study databases. All participants were given depression and anxiety scales at baseline, 4 and 8 weeks to test preliminary efficacy; satisfaction and acceptability were measured at trial end (i.e., eight weeks) and via interview.

RESULTS

There were 441 people who responded to recruitment materials, 74 pregnant people were screened; 19 partners did not complete enrolment, and 25 dyads were ineligible. There were 15 dyads per group (N = 30) who enrolled; all completed the study. The survey response rate was 90% but partners required nearly twice the number of reminders. No participant completed all lessons. Mean depression and anxiety scores dropped over time for dyads in control (M = -1.99, -1.53) and intervention (M = -4.80, -1.99). Intervention pregnant people's anxiety significantly decreased (M = -4.05; 95% CI [0.82, 7.27]) at time two compared to control. Twelve pregnant people and four partners participated in post-intervention interviews and suggested improvements for eMB.

CONCLUSION

Online dyadic interventions can potentially reduce PMAD symptoms. However, to feasibly study eMB with couples, strategies to increase program adherence are necessary. Tailoring interventions to overtly include partners may be advantageous.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05867680, 19/05/2023.

摘要

背景

未经治疗的围产期情绪和焦虑障碍 (PMAD) 会对短期和长期的健康和社会产生影响;在线认知行为疗法 (CBT) 干预可以减轻症状。尽管伴侣的支持具有保护作用,但在线干预很少针对夫妻。本研究基于对现有基于 CBT 的干预措施“母亲和婴儿在线课程”(eMB)的研究,通过对产前夫妇进行测试来检验其可行性。

方法

我们采用 1:1 平行设计进行了一项试点、随机、对照可行性试验。符合条件的参与者是孕妇(妊娠 13-30 周,GAD-7 或 PHQ-9 量表得分在 10 分或以上,表明焦虑或抑郁症状升高)及其同居伴侣,居住在密苏里州,能够使用互联网;双方均同意参加。招募通过 Facebook 广告、传单和滚雪球方式进行。干预组接受 eMB,对照组接受社区资源列表。我们从 eMB 分析和研究数据库中提取保留和依从性数据进行检查。所有参与者在基线、4 周和 8 周时接受抑郁和焦虑量表测试以检验初步疗效;在试验结束时(即 8 周)通过访谈测量满意度和可接受性。

结果

有 441 人回应了招募材料,74 名孕妇接受了筛查;19 名伴侣未完成入组,25 对夫妇不符合条件。每组有 15 对(N=30)入组;所有人都完成了研究。调查的回复率为 90%,但伴侣需要的提醒几乎是参与者的两倍。没有参与者完成了所有课程。两组参与者的抑郁和焦虑评分随时间推移均有所下降(对照组 M= -1.99,-1.53;干预组 M= -4.80,-1.99)。与对照组相比,干预组孕妇的焦虑在第二次评估时显著下降(M= -4.05;95%CI [0.82, 7.27])。12 名孕妇和 4 名伴侣参加了干预后的访谈,并对 eMB 提出了改进建议。

结论

在线夫妻干预措施可能有助于减轻 PMAD 症状。然而,为了与夫妻一起进行 eMB 的可行性研究,有必要制定提高项目依从性的策略。定制干预措施以明确包括伴侣可能是有利的。

试验注册

ClinicalTrials.gov NCT05867680,2023 年 5 月 19 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33a6/10585730/213d9e4c8bf5/12884_2023_6031_Fig1_HTML.jpg

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