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SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression.
Estevao, Carolina; Bind, Rebecca; Fancourt, Daisy; Sawyer, Kristi; Dazzan, Paola; Sevdalis, Nick; Woods, Anthony; Crane, Nikki; Rebecchini, Lavinia; Hazelgrove, Katie; Manoharan, Manonmani; Burton, Alexandra; Dye, Hannah; Osborn, Tim; Davis, Rachel E; Soukup, Tayana; Arias de la Torre, Jorge; Bakolis, Ioannis; Healey, Andy; Perkins, Rosie; Pariante, Carmine.
Afiliación
  • Estevao C; Department of Psychological Medicine, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK carolina.estevao@kcl.ac.uk.
  • Bind R; Department of Psychological Medicine, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
  • Fancourt D; Department of Behavioural Science and Health, University College London, London, UK.
  • Sawyer K; Department of Psychological Medicine, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
  • Dazzan P; Department of Psychological Medicine, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
  • Sevdalis N; Centre for Implementation Science, King's College London, London, UK.
  • Woods A; Department of Psychological Medicine, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
  • Crane N; Culture team, King's College London, London, UK.
  • Rebecchini L; Department of Psychological Medicine, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
  • Hazelgrove K; Department of Psychological Medicine, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
  • Manoharan M; South London and Maudsley NHS Foundation Trust, London, UK.
  • Burton A; Department of Behavioural Science and Health, University College London, London, UK.
  • Dye H; Breathe Arts Health Research, London, UK.
  • Osborn T; Breathe Arts Health Research, London, UK.
  • Davis RE; Centre for Implementation Science, King's College London, London, UK.
  • Soukup T; Centre for Implementation Science, King's College London, London, UK.
  • Arias de la Torre J; Centre for Implementation Science, King's College London, London, UK.
  • Bakolis I; CIBER, Madrid, Comunidad de Madrid, Spain.
  • Healey A; Centre for Implementation Science, King's College London, London, UK.
  • Perkins R; Department of Biostatistics and Health Informatics, King's College London, London, UK.
  • Pariante C; Health Service and Population Research Department, King's College London, London, UK.
BMJ Open ; 11(11): e052133, 2021 11 17.
Article en En | MEDLINE | ID: mdl-34789494
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Depresión Posparto / Canto Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Aspecto: Ethics Límite: Female / Humans Idioma: En Revista: BMJ Open Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Depresión Posparto / Canto Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Aspecto: Ethics Límite: Female / Humans Idioma: En Revista: BMJ Open Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido