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

Carolina Branco Estevao*, Rebecca Bind, Daisy Fancourt, Kristi Priestley, Paola Dazzan, Nick Sevdalis, Anthony Woods, Nikki Crane, Lavinia Rebecchini, Katie Hazelgrove, Manonmani Manoharan, Alexandra Burton, Hannah Dye, Tim Osborn, Rachel E. Davis, Tayana Soukup, Jorge Arias de la Torre, Ioannis Bakolis, Andy Healey, Rosie PerkinsCarmine Pariante

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)

Abstract

INTRODUCTION: 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.

METHODS AND ANALYSIS: 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.

ETHICS AND DISSEMINATION: Ethical approval has been granted by the London-West London and GTAC Research Ethics Committee, REC reference: 20/PR/0813.

TRIAL REGISTRATION NUMBER: NCT04834622; Pre-results.

Original languageEnglish
Article numbere052133
JournalBMJ Open
Volume11
Issue number11
Early online date17 Nov 2021
DOIs
Publication statusPublished - 17 Nov 2021

Fingerprint

Dive into the research topics of 'SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression'. Together they form a unique fingerprint.

Cite this