SHAPER-PND and the SHAPER-PDNO protocols: a trial for a community singing intervention for postnatal depression and the COVID-19 pandemic response study

INTRODUCTION: The SHAPER-PND study will analyse the clinical and implementation effectiveness of 10-week in-person singing sessions for postnatal depression in new mothers. An online pilot study, SHAPER-PNDO, was designed to meet the social distancing requirements of the COVID-19 pandemic, while investigating online delivery and COVID-19 anxiety specific questions. This abstract introduces the protocols for both studies, discuss the adaptations made for COVID-19 research and the biological samples collected from mothers in babies. METHODS AND ANALYSIS: For the SHAPER-PND study, 400 mothers and their babies will be recruited. The intervention group will attend 10 weekly singing sessions, facilitated by Breathe Arts Health Research. A control group will attend non-singing sessions for 10 weeks. A package of assessments will be collected from participants for clinical, mechanistic and implementation outcomes. Cortisol, oxytocin and other biological measures will be collected from saliva and hair samples. For SHAPER-PNDO, a total of 120 mothers and their babies will be recruited for the 6 weekly singing sessions intervention. The same package of assessments and saliva samples will be collected as for SHAPER-PND.