Clinical trial NCT02526407: The Impact of Creative Interventions on Symptoms of Postnatal Depression
Official title: The Impact of Creative Interventions on Symptoms of Postnatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Keywords: postnatal depression
mental wellbeing
baby blues
mothers
music
alternative therapies
Lead sponsor: Royal College of Music
Sponsor class: OTHER
Collaborators: name: Chelsea and Westminster NHS Foundation Trust
name: Imperial College London
First posted: 2015-08-18
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postnatal depression
timeFrame: Change from baseline at 6 weeks and 10 weeks
Secondary outcomes:
measure: Mental wellbeing
timeFrame: Change from baseline at 6 weeks and 10 weeks
measure: Self-esteem
timeFrame: Change from baseline at 6 weeks and 10 weeks
measure: Social functioning
timeFrame: Change from baseline at 6 weeks and 10 weeks
measure: Inflammatory immune response
timeFrame: Change from baseline at 6 weeks and 10 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: Centre for Performance Science, Royal College of Music
Study officials:
affiliation: Royal College of Music / Imperial College London
name: Aaron Williamon, PhD
role: STUDY_CHAIR
References:
citation: Fancourt D, Perkins R. Creative interventions for symptoms of postnatal depression: A process evaluation of implementation. Arts Health. 2019 Feb;11(1):38-53. doi: 10.1080/17533015.2017.1413398. Epub 2018 Jan 23.
citation: Perkins R, Yorke S, Fancourt D. How group singing facilitates recovery from the symptoms of postnatal depression: a comparative qualitative study. BMC Psychol. 2018 Aug 17;6(1):41. doi: 10.1186/s40359-018-0253-0.
citation: Fancourt D, Perkins R. Effect of singing interventions on symptoms of postnatal depression: three-arm randomised controlled trial. Br J Psychiatry. 2018 Feb;212(2):119-121. doi: 10.1192/bjp.2017.29.