The Impact of Creative Interventions on Symptoms of Postnatal Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 4
- 主要终点
- Postnatal depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who have a child up to 9 months old
- •Symptoms suggestive of PND at a minimum score of 10 on the EPDS
排除标准
- •Outside the limits of the number of weeks pregnant/post birth
- •Living outside England
- •Refusal to participants
结局指标
主要结局
Postnatal depression
时间窗: Change from baseline at 6 weeks and 10 weeks
Measured with the Edinburgh Postnatal Depression Scale
次要结局
- Self-esteem(Change from baseline at 6 weeks and 10 weeks)
- Inflammatory immune response(Change from baseline at 6 weeks and 10 weeks)
- Mental wellbeing(Change from baseline at 6 weeks and 10 weeks)
- Social functioning(Change from baseline at 6 weeks and 10 weeks)