Overview

This trial is active, not recruiting.

Condition depression, postpartum
Treatments singing, group play
Sponsor Royal College of Music
Collaborator Chelsea and Westminster NHS Foundation Trust
Start date October 2015
End date November 2016
Trial size 150 participants
Trial identifier NCT02526407, SATB2015

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.

Singing away the Blues 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(No Intervention)
Participants continue with usual care. No planned intervention.
(Active Comparator)
Participants take part in 10 weeks of group play activities for one hour per week with their baby in a community setting alongside any usual care they may be receiving.
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.
(Experimental)
Participants take part in 10 weeks of group singing activities for one hour per week with their baby in a community setting alongside any usual care they may be receiving.
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.

Primary Outcomes

Measure
Postnatal depression
time frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up

Secondary Outcomes

Measure
Mental wellbeing
time frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up
Self-esteem
time frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up
Social functioning
time frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up
Inflammatory immune response
time frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title The Impact of Creative Interventions on Symptoms of Postnatal Depression
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 80 women into each of the three interventions (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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Royal College of Music.