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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02526407
Other study ID # SATB2015
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 September 30, 2016

Study information

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

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 postnatal depression, 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 postnatal depression.

This project is an ambitious programme of research that investigates the effects of music on postnatal depression through two phases: a questionnaire study and an intervention study. This record is for the intervention study. The questionnaire study has a separate record. We are accepting host hospital sites for both.


Description:

The study tests the effectiveness of singing interventions led by the Royal College of Music at Chelsea and Westminster Hospital as a psychosocial tool to reduce the occurrence and effects of postnatal depression. It triangulates psychological, physiological, and biological data in a randomised control design to provide a comprehensive insight into the intervention's effects in comparison to a more common psychosocial intervention for new mothers (play groups) and a control group of no psychosocial interventions. The study aims to recruit 50-80 women into each of the three interventions (150-240 total).

The study will used a mixed-method methodology comprising validated psychological scales, in-depth qualitative interviews and observations and biomarker analysis. If results are promising, there are plans in place to scale the singing intervention to more hospitals and community settings.

Phase B will be open to NHS sites within the region of Chelsea and Westminster Hospital London from which women could travel to the sessions to take part.


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date September 30, 2016
Est. primary completion date July 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women who have a child up to 9 months old

- Symptoms suggestive of PND at a minimum score of 10 on the EPDS

Exclusion Criteria:

- Outside the limits of the number of weeks pregnant/post birth

- Living outside England

- Refusal to participants

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Singing
Sessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will learn songs with their babies and help to create new musical material together.
Group play
Sessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will take part in group play activities.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Royal College of Music Chelsea and Westminster NHS Foundation Trust, Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postnatal depression Measured with the Edinburgh Postnatal Depression Scale Change from baseline at 6 weeks and 10 weeks
Secondary Mental wellbeing Measured with the short Warwick-Edinburgh Mental Wellbeing Scale Change from baseline at 6 weeks and 10 weeks
Secondary Self-esteem Measured with the Rosenberg Self-esteem scale Change from baseline at 6 weeks and 10 weeks
Secondary Social functioning Measured with the Social Provisions Scale Change from baseline at 6 weeks and 10 weeks
Secondary Inflammatory immune response Measured with saliva samples to test for cortisol and cytokine activity Change from baseline at 6 weeks and 10 weeks
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