The Impact of Creative Interventions on Symptoms of Postnatal Depression

Depression, Postpartum Clinical Trial

Official title:

The Impact of Creative Interventions on Symptoms of Postnatal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526407
• Other study ID #: SATB2015
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

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