- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02526433
The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)
Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating PND, and flaws in the current pharmacological and psychological treatment models. Consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating PND.
This project is an ambitious programme of research that investigates links between the mental health of women in the later stages of pregnancy and first 9 months post birth and their use of psychosocial interventions including music.
Visão geral do estudo
Status
Condições
Descrição detalhada
The study uses an online questionnaire to achieve a cross-sectional view of the mental health of women across England in the final stages of pregnancy and the first 9 months post birth, how much and in what ways music is used by these women, and whether there are any associations between music and mental health. The study aims to recruit between 1,000 and 5,000 women to take the anonymous questionnaire. However, women who complete the questionnaire while still pregnant will be invited to complete three further questionnaires shortly post-birth and 3 months later to gather longitudinal data to analyse change across pregnancy into post-birth (aiming for 500 of the 1,000 undertaking this repeated measurement).
Phase A of the study will be open to NHS sites around England to take part.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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London, Reino Unido, SW7 2BS
- Centre for Performance Science, Royal College of Music
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Women who are more than 28 weeks pregnant OR up to 9 months post-birth
Exclusion Criteria:
- Outside the limits of the number of weeks pregnant/post birth
- Living outside England
- Refusal to participate
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Pregnancy women and new mothers
The study tracks what interventions women are already registered in and compares these with their mental wellbeing.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Depression
Prazo: Retrospective measure since the date of completion of the previous questionnaire
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Measured using the Edinburgh Postnatal Depression Scale
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Retrospective measure since the date of completion of the previous questionnaire
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Mental wellbeing
Prazo: Retrospective measure since the date of completion of the previous questionnaire
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Measured using the short Warwick-Edinburgh Mental Wellbeing Scale
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Retrospective measure since the date of completion of the previous questionnaire
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Social functioning
Prazo: Retrospective measure since the date of completion of the previous questionnaire
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Measured using the Social Provisions Scale
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Retrospective measure since the date of completion of the previous questionnaire
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Self-esteem
Prazo: Retrospective measure since the date of completion of the previous questionnaire
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Measured using the Rosenberg Self-esteem Scale
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Retrospective measure since the date of completion of the previous questionnaire
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Further questions assessing health and wellbeing including perceived health, health service utilisation, mother-infant bond and creative participation
Prazo: Retrospective measure since the date of completion of the previous questionnaire
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A range of self-report questions
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Retrospective measure since the date of completion of the previous questionnaire
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Aaron Williamon, PhD, Royal College of Music / Imperial College London
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SATB2015b
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