SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression.

Postnatal depression (PND) affects approximately 13% of new mothers. Community-based activities are sought after by many mothers, especially mothers that prefer not to access pharmacological or psychological interventions. Singing has shown positive effects in maternal mood and mother-child bonding. The Scaling-Up Health-Arts Programmes: Implementation and Effectiveness Research-Postnatal Depression study will analyse the clinical and implementation effectiveness of 10-week singing sessions for PND in new mothers. This protocol paper will focus on the clinical effectiveness of this trial. A total of 400 mothers with PND (with a score of at least 10 on the Edinburgh Postnatal Depression Scale) and their babies will be recruited for this hybrid type II randomised controlled trial. The intervention group will attend 10 weekly singing sessions held at community venues or online, facilitated by the arts organisation, Breathe Arts Health Research (Breathe). A control group will be encouraged to attend non-singing sessions in the community or online for 10 weeks. A package of assessments will be collected from participants for clinical, mechanistic and implementation outcomes, at different stages of the trial. Clinical assessments will include questionnaires and interviews for demographics, mental health and social measures, together with biological samples for measurement of stress markers; the study visits are at baseline, week 6 (mid-trial) and week 10 (end of trial), with follow ups at weeks 20 and 36. Multiple imputation will be used to deal with possible missing data and multivariable models will be fitted to assess differences between groups in the outcomes of the study. Ethical approval has been granted by the London-West London and GTAC Research Ethics Committee, REC reference: 20/PR/0813. NCT04834622; Pre-results.

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Déclaration de conflit d'intérêts

Competing interests: NS is the director of the London Safety and Training Solutions, which offers training in patient safety, implementation solutions and human factors to healthcare organisations. DF is a non-executive board director for Breathe Arts Health Research but she receives no financial compensation for her involvement. TS received funding for training cancer multidisciplinary teams in the assessment and quality improvement methods in the United Kingdom. TS serves as a consultant to F. Hoffmann-La Roche Diagnostics providing advisory research services in relation to innovations for cancer multidisciplinary teams and their care planning meetings in the United States of America. CP has received research and consultation funding from Boehringer Ingelheim and Johnson & Johnson for research on depression and inflammation, and by a Wellcome Trust strategy award to the Neuroimmunology of Mood Disorders and Alzheimer’s Disease (NIMA) Consortium (104025), which is also funded by Janssen, GlaxoSmithKline, Lundbeck and Pfizer; the work presented in this paper is unrelated to this funding.