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SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression
  1. Carolina Estevao1,
  2. Rebecca Bind1,
  3. Daisy Fancourt2,
  4. Kristi Sawyer1,
  5. Paola Dazzan1,
  6. Nick Sevdalis3,
  7. Anthony Woods1,
  8. Nikki Crane4,
  9. Lavinia Rebecchini1,
  10. Katie Hazelgrove1,
  11. Manonmani Manoharan5,
  12. Alexandra Burton2,
  13. Hannah Dye6,
  14. Tim Osborn6,
  15. Lorna Greenwood6,
  16. Rachel E Davis3,
  17. Tayana Soukup3,
  18. Jorge Arias de la Torre3,7,
  19. Ioannis Bakolis3,8,
  20. Andy Healey9,
  21. Rosie Perkins10,11,
  22. Carmine Pariante1
  1. 1Department of Psychological Medicine, King’s College London Institute of Psychiatry Psychology and Neuroscience, London, UK
  2. 2Department of Behavioural Science and Health, University College London, London, UK
  3. 3Centre for Implementation Science, King’s College London, London, UK
  4. 4Culture team, King’s College London, London, UK
  5. 5South London and Maudsley NHS Foundation Trust, London, UK
  6. 6Breathe Arts Health Research, London, UK
  7. 7CIBER, Madrid, Comunidad de Madrid, Spain
  8. 8Department of Biostatistics and Health Informatics, King’s College London, London, UK
  9. 9Health Service and Population Research Department, King’s College London, London, UK
  10. 10Centre for Performance Science, Royal College of Music, London, UK
  11. 11Faculty of Medicine, Imperial College London, London, UK
  1. Correspondence to Dr Carolina Estevao; carolina.estevao{at}kcl.ac.uk

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.

  • mental health
  • psychiatry
  • depression & mood disorders
  • immunology
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Footnotes

  • Twitter @carolinaestev, @csmony

  • Correction notice This article has been corrected since it was published. Lorna Greenwood has been added as an author and the contributors section has been updated.

  • Contributors All authors listed have contributed to the conception and design of the protocol and this manuscript. All authors have been involved in the drafting of the manuscript and have individually approved the version of the work published. Specifically, the contribution of each author falls within the following CRediT categories: CE, RB, KS, PD, NS, LR, KH, AB, RED, TS, JAdlT, IB and AH: conceptualisation, methodology and project administration. DF, RP and CP: conceptualisation, methodology, supervision and funding acquisition. NC and AW: conceptualisation, project administration and funding acquisition. MM, HD and TO: conceptualisation, project administration. LG: conceptualisation, project administration.

  • Funding This trial is part of the SHAPER programme, a Scaling-up Health-Arts Programme to scale up arts interventions. This programme is funded by the Wellcome Trust (award reference 219425/Z/19/Z). This work is additionally supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London and by a NIHR Senior Investigator to CP. NS, IB and AH’ research is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) South London at King’s College Hospital NHS Foundation Trust. NS and AH are members of King’s Improvement Science, which offers cofunding to the NIHR ARC South London and comprises a specialist team of improvement scientists and senior researchers based at King’s College London. Its work is funded by King’s Health Partners (Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, King’s College London and South London and Maudsley NHS Foundation Trust), Guy’s and St Thomas’ Charity and the Maudsley Charity. RED is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration: South London, at King’s College Hospital NHS Foundation Trust.

  • Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, NIHR or the Department of Health and Social Care.

  • 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.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.