The Impact of Creative Interventions on Symptoms of Postnatal Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Creative Interventions on Symptoms of Postnatal Depression

Conditions
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Depression, Postpartum

Intervention / Treatment
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* Behavioral: Singing
* Behavioral: Group play


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants continue with usual care. No planned intervention. | |
| Active Comparator: Group play<br>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. | Behavioral: Group play<br>* 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.<br>|
| Experimental: Singing<br>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. | Behavioral: Singing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postnatal depression | Measured with the Edinburgh Postnatal Depression Scale | Change from baseline at 6 weeks and 10 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postnatal depression, mental wellbeing, baby blues, mothers, music, alternative therapies