Community Singing Interventions for Postnatal Depression: a Hybrid Type II Effectiveness-implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- To assess the effectiveness of group singing interventions on symptoms of postnatal depression using the Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
Postnatal depression (PND) affects over 13% of new mothers but there is still not an ideal treatment for all cases. Pharmaceutical and psychotherapy have offered solutions but there are challenges in treatment uptake and adherence and long waiting-lists for psychotherapy. Many mothers attend group activities with their babies, some including music and singing. Community group singing has shown improvement in mental health and singing to babies has shown improvement in mother-infant interaction and reduced infant distress.
In this realm, Melodies for Mums (M4M) is a programme based in Lambeth and Southwark providing 10-week singing and music sessions for mothers with postnatal depression (PND) and their babies in community Children's Centres or online, according to government social distancing guidelines. Studies have demonstrated its effectiveness in reducing symptoms of PND faster than usual care or social groups, and preliminary process evaluations have suggested its suitability. It has also been identified as a strong way of engaging mothers from minority backgrounds who are less likely to seek professional support for their mental health. However, the programme is reliant on short-term grants and has not been implemented in clinical care. Therefore, there is a clear need to invest more research into this programme to help it achieve its potential.
The investigators aim to conduct M4M in a clinical trial aimed at women experiencing symptoms of postnatal depression in the boroughs of Southwark, Lambeth and Lewisham. The investigators will collect data on the wellbeing of the women through a series of interviews and questionnaires and the investigators will also collect biological samples for stress and immunity markers from mothers and babies.
In the long term the investigators intend to establish defined clinical referral pathways for patients from primary (GPs, community, among others) and secondary care (specialist doctor, hospital clinic) settings. In addition, the investigators will collect further evidence of the clinical, implementation and economic effectiveness of the intervention.
详细描述
Postnatal depression (PND) affects at least 12-15% of new mothers, with symptoms including fatigue, anhedonia, insomnia and irritability. However, challenges surround the fact that there is still no complete treatment solution. Although pharmacological treatment has had positive results, these are hampered by low uptake and adherence amongst mothers, while psychotherapy has produced mixed results and has similar challenges around low uptake or delayed treatment.
However, many mothers engage in community group activities with their babies, such as attending mother-infant play groups. Such activities have been identified as ways of relaxing mothers, providing good sources of social interaction, decreasing the monotony of each day and also providing a sense of personal fulfillment for mothers. There is also a growing body of evidence demonstrating the effects of community group singing on mental health. Singing to new babies is practised in cultures around the world, and research has demonstrated valuable benefits such as improving mother-infant interaction and reducing distress in babies. Listening to music during pregnancy is also associated with higher levels of wellbeing and reduced symptoms of PND in the first 3 months post-birth, while daily singing to babies is associated with fewer symptoms of PND and higher levels of wellbeing, self-esteem and perceived mother-infant bond. Consequently, there is a strong theoretical background to why singing could support mothers with PND.
While small studies have supported the efficacy of this intervention, the present large scale study is needed to measure effectiveness and promote the uptake within the NHS, as well as in order to fully understand the mechanisms underpinning its efficacy.
Trial design and aims: These sessions/activities will be delivered for 10-weeks and the women will be followed up at 20- and 36-weeks post randomisation. On week 0 (before the start of the study), 6, 10, 20 and 36 women will either be visited by members of the KCL research team (to be assessed given questionnaires and provide samples) or will complete online questionnaires (see table of measures). The end of the trial for a participant will be after the 36-week follow up, or withdrawal. This is a multi-centre trial that will be run in locations across London (primarily in the boroughs of Lewisham, Lambeth and Southwark), specifically in children's or community venues. These venues will be thoroughly safety- and risk-assessed in light of COVID-19 and adherence to any COVID-secure measures will be closely monitored by Breathe. In the event that one or several women need to self-isolate due to confirmed or suspected exposure to COVID-19, the sessions will be delivered to her/them online via Zoom. This will allow for the sessions to still be conducted in person with the remaining women.
In order to enrol a sufficiently large sample of women, there will be 12 blocks of the 10-week singing programme in total: 10 intervention blocks will be for the experimental group, and 2 blocks will be for women in the wait-list control group that wish to take part in the singing sessions. The 2 wait-list blocks will be offered singing sessions after a woman has completed the first 10 weeks of the study and no data will be collected regarding these singing sessions, apart from the control follow-up data that this group is expected to provide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 or older
- •Satisfactory understanding of English
- •Women who have a child between 0 and up to 9 months old
- •Women with postnatal depression diagnosed using symptoms of PND at a minimum score of 10 on the Edinburgh Postnatal Depression Scale (EPDS) AND meeting diagnostic criteria for major depressive episode on the Structured Clinical Interview for DSM-IV Disorders (SCID)
- •Access to an internet-connected device (mobile phone, tablet, computer or laptop) to allow completion of assessments and participation in the singing sessions.
排除标准
- •Child outside of the age-range specified
- •Unable to give informed consent
结局指标
主要结局
To assess the effectiveness of group singing interventions on symptoms of postnatal depression using the Edinburgh Postnatal Depression Scale (EPDS)
时间窗: The primary outcome measure is change in EPDS total score between baseline and Week 10 (end of treatment).
To assess the effectiveness of group singing interventions on symptoms of postnatal depression using the Edinburgh Postnatal Depression Scale (EPDS) The EPDS was developed to assist health professionals in detecting mothers suffering from Postnatal depression. The scale consists of 10 short statements. A mother checks off one of four possible answers that is closest to how she has felt during the past week. The EPDS is measured on a scale of 0-30, where a higher score indicates more severe depression. Mothers scoring above 12 or 13 are likely to be suffering from depression.
To assess the acceptability of the intervention using the Acceptability of Intervention Measure (AIM)
时间窗: The primary outcome implementation measure is acceptability collected at week 10 (end of treatment).
To assess the acceptability of the singing intervention, using the Acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean.
次要结局
- To assess whether singing improves (changes) further aspects of mental health, including depression using the Hamilton Depression Rating Scale (HDRS).(Compare change between baseline and weeks 6, 10, 20 and 36.)
- To ascertain whether singing improves the perceived mother-infant relationship using the Maternal Postpartum Attachment Scale (MPAS)(Compare change between baseline and weeks 6, 10, 20 and 36.)
- To assess the acceptability of the intervention using the Intervention Measure (AIM)(Quantitative data collection at week 10 (end of intervention).)
- To assess the feasibility of the intervention using semi-structured interviews(Quantitative data collection at week 10 (end of intervention).)
- To ascertain whether singing improves the perceived mother-infant relationship using the Parent Reflective Functioning Questionnaire (PRFQ)(Compare change between baseline and weeks 6, 10, 20 and 36.)
- To assess reasons for perceived acceptability of the intervention using semi-structured interviews(Qualitative data collection at week 10 (end of intervention).)
- To assess the appropriateness of the intervention using Intervention Appropriateness Measure (IAM)(Qualitative data collection at week 10 (end of intervention).)
- To assess the cost effectiveness of the intervention using the 5-level EQ-5D version (EQ5D-5L)(Quantitative and qualitative data collection at week 10 (end of intervention).)
- To assess whether singing improves (changes) further aspects of mental health, including depression using the Beck Depression Inventory (BDI).(Compare change between baseline and weeks 6, 10, 20 and 36.)
- To assess whether singing improves (changes) further aspects of mental health, including stress using the Perceived Stress Scale (PSS)(Compare change between baseline and weeks 6, 10, 20 and 36.)
- To ascertain whether singing improves the observed mother-infant interaction using the Crittenden CARE-Index (CCI)(Compare change between baseline and weeks 10 and 36.)
- To identify whether there are biological mechanisms underpinning the psychological outcomes assessed using changes in measurements in salivary oxytocin(Compare change between week 1 and weeks 6 and 10.)
- To identify how the singing sessions affect the lived experience of mothers with PND using focus groups(Qualitative data collection at week 10 (end of intervention).)
- To assess the appropriateness of the intervention using semi-structured interviews(Qualitative data collection at week 10 (end of intervention).)
- To assess the adoption of the intervention using participants and stakeholder enrollment rates(Quantitative data collection at week 10 (end of intervention).)
- To assess factors affecting the sustainability and scalability of the intervention using semi-structured interviews(Quantitative and qualitative data collection at week 10 (end of intervention).)
- To assess whether singing improves (changes) further aspects of mental health, including wellbeing using the Office for National Statistics Wellbeing Scale (ONS):(Compare change between baseline and weeks 6, 10, 20 and 36.)
- To assess whether singing improves (changes) further aspects of mental health, including anxiety, using the State-Trait Anxiety Scale (STAI)(Compare change between baseline and weeks 6, 10, 20 and 36.)
- To ascertain whether singing improves social support and reduces loneliness using the UCLA Loneliness Scale(Compare change between baseline and weeks 6, 10, 20 and 36.)
- To identify whether there are biological mechanisms underpinning the psychological outcomes assessed using changes in measurements in stress hormones, including hair cortisol, diurnal cortisol and salivary cytokines(Compare change between week 1 and weeks 6 and 10.)
- To explore the phenomenology of PND and how singing intersects with PND among women with particular risk factors for PND (traumatic birth, adverse childhood experiences, and social isolation/loneliness) using semi-structured interviews(Qualitative data collection at week 10 (end of intervention).)
- To assess the feasibility of the intervention using the Feasibility of Intervention Measure (FIM)(Quantitative data collection at week 10 (end of intervention).)
- To assess intervention adherence and attrition rates using attendance data (rates and drop out reasons)(Quantitative data collection at week 10 (end of intervention).)
- To assess the cost effectiveness of the intervention using the Adult Service Use Schedule (AD-SUS)(Quantitative and qualitative data collection at week 10 (end of intervention).)
- To ascertain whether singing improves social support and reduces loneliness using the Multidimensional Scale of Perceived Social Support (MSPSS)(Compare change between baseline and weeks 6, 10, 20 and 36.)
- To assess uptake/reach of the intervention using recruitment rate records(Quantitative data collection at week 10 (end of intervention).)
- To assess the cost effectiveness of the intervention using implementation activity logs (to estimate implementation costs).(Quantitative and qualitative data collection at week 10 (end of intervention).)
- To assess factors affecting the sustainability and scalability of the intervention using the NOMAD Scale:(Quantitative and qualitative data collection at week 10 (end of intervention).)