Department of Obstetrics and Gynecology, Cumming School of Medicine, University of Calgary, 2500 University Drive, NW, Calgary, AB, T2N 1N4, Canada.
University of British Columbia, Vancouver, Canada.
Trials. 2023 Mar 30;24(1):240. doi: 10.1186/s13063-023-07077-7.
Antenatal depression (AD) is the most common complication of pregnancy in developed countries and increases the risk of preterm birth (PTB). Many pregnant individuals with AD do not obtain treatment due in part to risks associated with antidepressant medications, the expense and wait times for psychological services, and perceived stigma. Accessible and timely treatment of antenatal depression is crucial to minimize foetal impacts and associated long-term child health outcomes. Previous studies show that behavioural activation and peer support are promising avenues of treatment for perinatal depression. Additionally, remote and paraprofessional counselling interventions show promise as more accessible, sustainable, and cost-effective treatment avenues than traditional psychological services. The primary aim of this trial is to test the effectiveness of a remote, behavioural activation and peer support intervention, administered by trained peer para-professionals, for increasing gestational age at delivery among those with antenatal depression. The secondary aims are to evaluate the effectiveness for treating AD prior to delivery, with persistence into the postpartum; improving anxiety symptoms; and improving parenting self-efficacy compared to controls.
A two-arm, single-blinded, parallel groups randomized controlled trial (RCT) with repeated measures will be conducted. Participants scoring >10 on the Edinburgh Postnatal Depression Scale will be recruited from the larger P3 cohort and invited to enroll. Assessments will be conducted prior to 27 weeks' gestation at trial intake (T1), post-intervention, prior to delivery (T2), 5-6 months postpartum (T3), and 11-12 months postpartum (T4) and will include self-report questionnaires and linked medical records.
Our remote, peer paraprofessional-delivered behavioural activation plus peer support intervention has the potential to successfully reduce symptoms of AD, which may in turn decrease the risk of PTB and subsequent health impacts. The current trial builds on previous findings and uses a patient-oriented approach to address priorities for patient care and to provide a cost-effective, accessible, and evidence-based treatment to pregnant individuals with AD.
International Standard Randomised Controlled Trial Number (ISRCTN) registry (ISRCTN51098220) ISRCTN51098220. Registered on April 7, 2022.
产前抑郁症（AD）是发达国家妊娠最常见的并发症，增加了早产（PTB）的风险。由于抗抑郁药物相关的风险、心理服务的费用和等待时间以及感知到的耻辱感，许多患有 AD 的孕妇并未得到治疗。及时治疗产前抑郁症对于最大限度地减少胎儿的影响和相关的长期儿童健康结果至关重要。先前的研究表明，行为激活和同伴支持是治疗围产期抑郁症的有前途的途径。此外，远程和准专业咨询干预措施显示出比传统心理服务更具可及性、可持续性和成本效益的治疗途径的潜力。本试验的主要目的是测试由经过培训的同伴准专业人员管理的远程行为激活和同伴支持干预措施对提高患有产前抑郁症的孕妇分娩时的胎龄的有效性。次要目标是评估在分娩前治疗 AD 的有效性，以及在分娩后持续治疗；改善焦虑症状；以及与对照组相比，改善育儿自我效能感。
将进行一项两臂、单盲、平行组随机对照试验（RCT），并进行重复测量。将从较大的 P3 队列中招募 Edinburgh Postnatal Depression Scale 评分>10 的参与者，并邀请他们参加。在试验摄入（T1）时进行评估，即在 27 周妊娠之前，干预后，在分娩前（T2），产后 5-6 个月（T3）和产后 11-12 个月（T4），并将包括自我报告问卷和相关的医疗记录。
我们的远程、同伴准专业人员提供的行为激活加同伴支持干预措施有可能成功减轻 AD 的症状，这反过来可能降低 PTB 和随后的健康影响的风险。目前的试验建立在前人的发现基础上，并采用以患者为中心的方法来解决患者护理的优先事项，并为患有 AD 的孕妇提供经济有效的、可及的、基于证据的治疗方法。
国际标准随机对照试验编号（ISRCTN）登记处（ISRCTN51098220）ISRCTN51098220。于 2022 年 4 月 7 日注册。
