Maternal low-intensity psychosocial telemental interventions in response to COVID-19 in Qatar: study protocol for a randomized controlled trial

Abstract

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.