Hamad Medical Corporation, Doha, Qatar.
Primary Health Care Corporation, Doha, Qatar.
Trials. 2021 Jun 7;22(1):382. doi: 10.1186/s13063-021-05339-w.
As COVID-19 is spreading, new psychological health problems are suspected to be emerging among pregnant women. Higher maternal mental health distress, including perinatal anxiety, depression, and COVID-19-specific phobia, is supposed to be increasing during the pandemic, which impacts pregnant women's health and their infants and calls for intervention. Due to the social distancing protocols posed by the pandemic, telemental health interventions have fast become the most common form of psychosocial support for maternal mental health. However, there is no evidence of the effectiveness of maternal low-intensity psychosocial telemental interventions in improving mental health outcomes. The trial's objective is to evaluate the clinical efficacy of telemental low-intensity psychosocial interventions in pregnant and postpartum women attending the Women Wellness and Research Centre in Qatar in the era of the COVID-19 pandemic.
The clinical trial is randomized in which pregnant women will be assigned equally through block randomization between two arms: (1) a control group and (2) an intervention group. The primary endpoint is the perinatal psychological distress, including perinatal depression, anxiety, and COVID-19 phobia in their third trimester; the secondary, tertiary, fourth, and fifth endpoints will be in the postnatal period (3-5 weeks, 2-4 months, 5-7 months, and 8-10 months). This trial involves pregnant women in their second trimester with no mental health illness history who communicate in English and Arabic and consent to participate. A sample size of 58 (29 participants per arm) is targeted.
This study will provide recommendations about the efficacy of low-intensity psychosocial maternal telemental interventions to be implemented as a preventive service.
2a-ClinicalTrials.gov NCT04594525 . Registered on October 20, 2020.
随着 COVID-19 的传播，人们怀疑孕妇中会出现新的心理健康问题。在大流行期间，孕产妇心理健康问题（包括围产期焦虑、抑郁和 COVID-19 特定恐惧症）应该会增加，这会影响孕妇及其婴儿的健康，需要进行干预。由于大流行期间采取了社交距离协议，远程心理健康干预迅速成为孕产妇心理健康的最常见形式的社会心理支持。然而，目前尚无证据表明孕产妇低强度心理社会远程干预可以改善心理健康结果。本试验的目的是评估在 COVID-19 大流行期间，卡塔尔妇女健康与研究中心为孕妇和产后妇女提供的远程低强度心理社会干预的临床疗效。
本临床试验为随机分组，通过区组随机化将孕妇平均分为两组：（1）对照组和（2）干预组。主要终点是妊娠晚期的围产期心理困扰，包括围产期抑郁、焦虑和 COVID-19 恐惧症；次要、三级、四级和五级终点将在产后期间（3-5 周、2-4 个月、5-7 个月和 8-10 个月）进行。本试验涉及有第二孕期且无精神病史的孕妇，她们能够用英语和阿拉伯语交流并同意参加。目标样本量为 58 名（每组 29 名参与者）。
本研究将为实施作为预防服务的低强度心理社会孕产妇远程干预的疗效提供建议。
2a-ClinicalTrials.gov NCT04594525。于 2020 年 10 月 20 日注册。
