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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02526433
Other study ID # SATB2015b
Secondary ID
Status Completed
Phase N/A
First received August 14, 2015
Last updated April 12, 2017
Start date October 19, 2015
Est. completion date January 31, 2017

Study information

Verified date April 2017
Source Royal College of Music
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 2558
Est. completion date January 31, 2017
Est. primary completion date January 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Centre for Performance Science, Royal College of Music London

Sponsors (2)

Lead Sponsor Collaborator
Royal College of Music Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Measured using the Edinburgh Postnatal Depression Scale Retrospective measure since the date of completion of the previous questionnaire
Secondary Mental wellbeing Measured using the short Warwick-Edinburgh Mental Wellbeing Scale Retrospective measure since the date of completion of the previous questionnaire
Secondary Social functioning Measured using the Social Provisions Scale Retrospective measure since the date of completion of the previous questionnaire
Secondary Self-esteem Measured using the Rosenberg Self-esteem Scale Retrospective measure since the date of completion of the previous questionnaire
Secondary Further questions assessing health and wellbeing including perceived health, health service utilisation, mother-infant bond and creative participation A range of self-report questions Retrospective measure since the date of completion of the previous questionnaire
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