ABSTRACT
Background: The lethal potential of COVID-19 was often emphasized and repeatedly brought to the attention of pregnant women, leading to a higher level of anxiety, depression, and COVID-19-specific phobia among this population. Furthermore, legislation forced social distancing and isolation to interrupt the infection cycle. Together these factors resulted in higher maternal mental health distress requiring intervention. Nevertheless, there is a lack of evidence regarding the impact of low-intensity psychosocial telemental interventions on maternal mental health outcomes. Therefore, the objective of this pilot study is to assess the efficacy of video low-intensity psychosocial telemental maternal intervention on COVID-19-specific phobia, antenatal depression, and anxiety among pregnant women. We hypothesized that the intervention arm would be superior to the control arm. A parallel design randomized interventional controlled trial with 1:1 randomization was conducted at the Women Wellness and Research Center. We enrolled fifty-eight pregnant women in their second trimester who spoke English or Arabic. We assessed antenatal anxiety, depression, and Covid-19-specific phobia at baseline (T0), and thirty-three pregnant women completed the follow-up after four weeks (T1). Pregnant women receiving psychotropic medications and follow up in mental health services were excluded. Results: A low-intensity psychosocial telemental maternal session helps reduce antenatal anxiety. We found statistically significant differences in antenatal anxiety scores between the intervention (2.4 ± 2.2) and control (4.2 ± 1.6) groups (p = 0.013) with a large effect size of Hedges' g value (0.96, 0.22-1.74). The absolute risk reduction was 27.27 percent. However, the intervention had no statistically significant effect on reducing antenatal depression or COVID-19-specific phobia. Conclusions: Low-intensity psychosocial telemental maternal sessions effectively reduce antenatal anxiety. While our findings are promising, further RCTs are needed to replicate these findings. Trial registration: 2a-ClinicalTrials.gov identifier: NCT04594525.. Registered on 20/October/2020; updated 9/March/ 2022. Available from: Maternal Telemental Health Interventions in Response to Covid-19* - Full Text View - ClinicalTrials.gov.
ABSTRACT
INTRODUCTION: 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. METHODS AND ANALYSIS: 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. DISCUSSION: This study will provide recommendations about the efficacy of low-intensity psychosocial maternal telemental interventions to be implemented as a preventive service. TRIAL REGISTRATION: 2a-ClinicalTrials.gov NCT04594525 . Registered on October 20, 2020.