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 Perkins; Carmine Pariante

doi:10.1136/bmjopen-2021-052133

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 journal › Article › peer-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 language	English
Article number	e052133
Journal	BMJ Open
Volume	11
Issue number	11
Early online date	17 Nov 2021
DOIs	https://doi.org/10.1136/bmjopen-2021-052133 https://doi.org/10.1136/bmjopen-2021-052133
Publication status	Published - 17 Nov 2021

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https://bmjopen.bmj.com/content/11/11/e052133Licence: CC BY

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Branco Estevao, C., Bind, R., Fancourt, D., Priestley, K., Dazzan, P., Sevdalis, N., Woods, A., Crane, N., Rebecchini, L., Hazelgrove, K., Manoharan, M., Burton, A., Dye, H., Osborn, T., Davis, R. E., Soukup, T., Arias de la Torre, J., Bakolis, I., Healey, A., ... Pariante, C. (2021). SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression. BMJ Open, 11(11), Article e052133. https://doi.org/10.1136/bmjopen-2021-052133, https://doi.org/10.1136/bmjopen-2021-052133

@article{3cb8ec89498a4719ab16517579abf454,

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

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.",

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

note = "Funding Information: SHAPER is a multidisciplinary research programme funded by the Wellcome Trust that is hosted by King{\textquoteright}s College London (Sponsor) and University College London. The SHAPER-PND study described here is Hybrid Type II Effectiveness-Implementation RCT, where equal focus is placed on the effectiveness of the intervention and the effectiveness of its implementation.38 Funding Information: 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. 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{\textquoteright}s College London and by a NIHR Senior Investigator to CP. NS, IB and AH{\textquoteright} research is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) South London at King{\textquoteright}s College Hospital NHS Foundation Trust. NS and AH are members of King{\textquoteright}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{\textquoteright}s College London. Its work is funded by King{\textquoteright}s Health Partners (Guy{\textquoteright}s and St Thomas{\textquoteright} NHS Foundation Trust, King{\textquoteright}s College Hospital NHS Foundation Trust, King{\textquoteright}s College London and South London and Maudsley NHS Foundation Trust), Guy{\textquoteright}s and St Thomas{\textquoteright} Charity and the Maudsley Charity. RED is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration: South London, at King{\textquoteright}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{\textquoteright}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. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.",

year = "2021",

month = nov,

day = "17",

doi = "10.1136/bmjopen-2021-052133",

language = "English",

volume = "11",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "11",

}

Branco Estevao, C , Bind, R, Fancourt, D, Priestley, K , Dazzan, P , Sevdalis, N, Woods, A, Crane, N, Rebecchini, L , Hazelgrove, K, Manoharan, M, Burton, A, Dye, H, Osborn, T, Davis, RE, Soukup, T, Arias de la Torre, J , Bakolis, I, Healey, A, Perkins, R & Pariante, C 2021, 'SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression', BMJ Open, vol. 11, no. 11, e052133. https://doi.org/10.1136/bmjopen-2021-052133, https://doi.org/10.1136/bmjopen-2021-052133

TY - JOUR

T1 - SHAPER-PND trial

T2 - clinical effectiveness protocol of a community singing intervention for postnatal depression

AU - Branco Estevao, Carolina

AU - Bind, Rebecca

AU - Fancourt, Daisy

AU - Priestley, Kristi

AU - Dazzan, Paola

AU - Sevdalis, Nick

AU - Woods, Anthony

AU - Crane, Nikki

AU - Rebecchini, Lavinia

AU - Hazelgrove, Katie

AU - Manoharan, Manonmani

AU - Burton, Alexandra

AU - Dye, Hannah

AU - Osborn, Tim

AU - Davis, Rachel E.

AU - Soukup, Tayana

AU - Arias de la Torre, Jorge

AU - Bakolis, Ioannis

AU - Healey, Andy

AU - Perkins, Rosie

AU - Pariante, Carmine

N1 - Funding Information: SHAPER is a multidisciplinary research programme funded by the Wellcome Trust that is hosted by King’s College London (Sponsor) and University College London. The SHAPER-PND study described here is Hybrid Type II Effectiveness-Implementation RCT, where equal focus is placed on the effectiveness of the intervention and the effectiveness of its implementation.38 Funding Information: 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. 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. Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

PY - 2021/11/17

Y1 - 2021/11/17

N2 - 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.

AB - 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.

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U2 - 10.1136/bmjopen-2021-052133

DO - 10.1136/bmjopen-2021-052133

M3 - Article

C2 - 34789494

SN - 2044-6055

VL - 11

JO - BMJ Open

JF - BMJ Open

IS - 11

M1 - e052133

ER -

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

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