The Impact of Creative Interventions on Symptoms of Postnatal Depression

Not Applicable

Completed

• Conditions: Depression, Postpartum

• Registration Number: NCT02526407
• Lead Sponsor: Royal College of Music

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-14
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Study Start: 2015-10-19
• Primary Completion: 2016-07-31
• Study Completion: 2016-09-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 153

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postnatal depression	Change from baseline at 6 weeks and 10 weeks	Measured with the Edinburgh Postnatal Depression Scale

Secondary Outcome Measures

Name	Time	Method
Self-esteem	Change from baseline at 6 weeks and 10 weeks	Measured with the Rosenberg Self-esteem scale
Inflammatory immune response	Change from baseline at 6 weeks and 10 weeks	Measured with saliva samples to test for cortisol and cytokine activity
Mental wellbeing	Change from baseline at 6 weeks and 10 weeks	Measured with the short Warwick-Edinburgh Mental Wellbeing Scale
Social functioning	Change from baseline at 6 weeks and 10 weeks	Measured with the Social Provisions Scale

Trial Locations

Locations (2)

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom

Centre for Performance Science, Royal College of Music; 🇬🇧 London, United Kingdom