- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
London, Regno Unito, SW7 2BS
- Centre for Performance Science, Royal College of Music
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Pregnancy women and new mothers
The study tracks what interventions women are already registered in and compares these with their mental wellbeing.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Depression
Lasso di tempo: Retrospective measure since the date of completion of the previous questionnaire
|
Measured using the Edinburgh Postnatal Depression Scale
|
Retrospective measure since the date of completion of the previous questionnaire
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mental wellbeing
Lasso di tempo: Retrospective measure since the date of completion of the previous questionnaire
|
Measured using the short Warwick-Edinburgh Mental Wellbeing Scale
|
Retrospective measure since the date of completion of the previous questionnaire
|
|
Social functioning
Lasso di tempo: Retrospective measure since the date of completion of the previous questionnaire
|
Measured using the Social Provisions Scale
|
Retrospective measure since the date of completion of the previous questionnaire
|
|
Self-esteem
Lasso di tempo: Retrospective measure since the date of completion of the previous questionnaire
|
Measured using the Rosenberg Self-esteem Scale
|
Retrospective measure since the date of completion of the previous questionnaire
|
|
Further questions assessing health and wellbeing including perceived health, health service utilisation, mother-infant bond and creative participation
Lasso di tempo: Retrospective measure since the date of completion of the previous questionnaire
|
A range of self-report questions
|
Retrospective measure since the date of completion of the previous questionnaire
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Aaron Williamon, PhD, Royal College of Music / Imperial College London
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SATB2015b
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Depressione, dopo il parto
-
Northwestern UniversityReclutamento
-
The University of Texas Health Science Center,...CompletatoPostpartum | Turni di mediciStati Uniti
-
University of PittsburghTuscarora Intermediate Unit 11Reclutamento
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletatoPostpartumStati Uniti, Guatemala
-
Assistance Publique Hopitaux De MarseilleSconosciuto
-
Selcuk UniversitySelcuk University Scientific Research Projects UnitReclutamento
-
Cairo UniversityReclutamento
-
FHI 360Ghana Health Services; Ministry of Health, ZambiaCompletatoPeriodo postpartumGhana, Zambia
-
London School of Hygiene and Tropical MedicineDepartment for International Development, United Kingdom; Economic and Social... e altri collaboratoriCompletatoPeriodo postpartumBurkina Faso