- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, SW7 2BS
- Centre for Performance Science, Royal College of Music
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Depression
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental wellbeing
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Aaron Williamon, PhD, Royal College of Music / Imperial College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SATB2015b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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