Online Singing Interventions for Postnatal Depression in Times of Social Isolation: a Single Arm Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- To Assess the Effectiveness of Online Group Singing Interventions on Symptoms of Postnatal Depression Using the Edinburgh Postnatal Depression Scale (EPDS)
研究概览
简要总结
Melodies for Mums (M4M) is an intervention developed and tested as part of a collaboration between the Royal College of Music, Imperial College London and University College London from 2015-2017. The programme involved weekly singing classes for mothers and babies delivered in groups of 8-12 participants in Children's Centres for 10 weeks. M4M was tested in a three-arm RCT involving 134 mothers with PND (with an Edinburgh Postnatal Depression Scale (EPDS) score above 10), compared with a comparison group (10 weeks of creative play classes) or care as usual (wait-list control). The study found that mothers with moderate-severe symptoms of PND who participated in the programme with their baby had a significantly faster improvement in symptoms than mothers in usual care. Specifically, the mothers in the singing group had an average EPDS score of 15.7 at baseline (moderate depression), which dropped to 10.3 by week 6 and 9.4 by week 10. This improvement equated to an average 35% decrease in depressive symptoms across the first 6 weeks, by which point 65% of the singing group no longer had an EPDS above 13.
While funding has been secured to upscale this intervention as part of the SHAPER-PND programme, funded by the Wellcome Trust, the recent lockdown has not only halted the programme in its face-to-face format, but also prompted the interest in developing an online version that can be used (1) if the requirement for social distancing, even when the lockdown is relaxed, makes impossible the delivery of the programme; and (2) to broaden the reach to a nationwide delivery and extending to a wider population that may not have been able to attend in-person sessions due to geographical constraints or severity of symptoms.
M4M online is a 6-week intervention for mothers with PND. The original M4M programme would be delivered face-to-face in groups of 8-12 mothers in weekly sessions lasting one hour. However, due to the current situation with COVID-19, we will therefore modify the original face-to-face intervention for this online study, as follows:
- Groups of around 15-17 women to ensure that all participants can be visible on one screen during online delivery to create a stronger community and connection
- Offer 6 weeks of intervention, also building on the evidence from the face-to-face intervention that by 6 weeks there is already a significant improvement in depressive symptoms compared with control interventions
- Introduce a two-week lead-in period before the beginning of the six-session course, where mothers will be able to use WhatsApp and at least one (monitored) Zoom session to get to know each other.
详细描述
This single-arm clinical trial aims, in a period of 12 months, to pilot and evaluate an online delivery of Melodies for Mums with the ambition:
- To develop a remote intervention that can become a mainstream therapeutic tool not only at times of social isolation and distancing, but also for mothers who cannot leave their houses (e.g. because of mental health difficulties or medical comorbidities) or who live in areas where the intervention is unavailable;
- To create a separate control group to the original face-to-face intervention, as the investigators are still aiming to deliver the original SHAPER-PND when the investigators will be able to start again; and
- To make the best use of the expertise/experience available within the researchers and artists community brought together by the Wellcome Trust funding for the SHAPER-PND study.
In light of the limitations imposed by the current pandemic, the investigators aim to deliver M4M using a virtual platform to replace the in-person singing sessions. To achieve this, the investigators will deliver a more advanced version of a 'virtual choir' but keeping to the framework of the existing M4M programme; the investigators take the learnings by Breathe Arts Health Research from their Breathe Sing group for individuals with respiratory conditions. Prior to lockdown, this group met fortnightly in-person to use singing to benefit physical and mental health. During the COVID-19 pandemic, this group has moved online and is continuing to have excellent uptake with weekly attendance numbers higher than when the group was delivered in-person. M4M online will take a similar format, consisting of weekly sessions of one hour each, where women connect via Zoom and sing from their home while following the leader. To avoid the inevitable problems with Wi-Fi delays and instability, all participants are muted at certain times in the session but can all hear the singing leader throughout. The singing leader will also use a backing track that will be recorded specifically to support delivery, and has other voices and harmonies included to amplify the experience of singing with others. An additional Breathe member of staff will support participants to set up the online connection before the sessions and help them troubleshoot during the session. All participants are also connected via a WhatsApp group (monitored by Breathe), and there will be a space at the beginning and end of the sessions where all participants are unmuted and can chat with the artist or their peers, in an unstructured way.
M4M online will be delivered as a single-arm clinical trial, without a control group. Participants will be recruited in the community, mostly via social media and other signposting methods according to the usual procedures carried out by Breathe for recruiting into the face-to-face M4M programme but with enhanced advertisement and social media reach nationally. Before entering the study, mothers will be assessed by the research team, and if eligible, will be allocated to a singing group for 6 weekly sessions. Participants will remain in the same group to allow greater sense of community and familiarity with the artist, facilitator, and the other participants. Participants will be regularly assessed by the researchers and if they give consent, will provide biological samples. Follow up will be carried out 10 and 26 weeks after completion of the trial.
Setting: This is a single-centre trial that will be run online across the UK via the platform Zoom. In order to enrol a sufficiently large sample of women, there will be 4 blocks of the 6-week singing sessions in total. Women will be followed up at weeks 16 and 32.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 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 EPDS.
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Child outside of the age-range specified
- •Unable to give informed consent
研究组 & 干预措施
Intervention
M4M online is a 6-week intervention for mothers with PND. The original M4M programme would be delivered face-to-face in groups of 8-12 mothers in weekly sessions lasting one hour. However, due to the current situation with COVID-19, we will therefore modify the original face-to-face intervention for this online study, as follows:
- Run groups of around 15-17 women to ensure that all participants can be visible on one screen during online delivery to create a stronger sense of community and connection
- Offer 6 weeks of intervention, also building on the evidence from the face-to-face intervention that by 6 weeks there is already a significant improvement in depressive symptoms compared with control interventions24
- Introduce a two-week lead-in period before the beginning of the six-session course, where mothers will be able to use WhatsApp and at least one (monitored) Zoom session to get to know each other.
干预措施: Melodies for Mums (Behavioral)
结局指标
主要结局
To Assess the Effectiveness of Online Group Singing Interventions on Symptoms of Postnatal Depression Using the Edinburgh Postnatal Depression Scale (EPDS)
时间窗: The primary outcome measure is changes in EPDS total score between baseline and Week 6 (end of treatment).
To assess the effectiveness of online 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.
次要结局
- To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Stress Using the Perceived Stress Scale (PSS)(Compare changes between baseline and weeks 3, 6, 16, 32.)
- To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Depression Using the Hamilton Depression Rating Scale (HDRS)(Compare changes between baseline and weeks 6 (end of treatment).)
- To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Depression Using the Beck Depression Inventory (BDI).(Compare changes between baseline and weeks 3, 6, 16, 32.)
- To Identify Whether There Are Biological Mechanisms Underpinning the Psychological Outcomes Assessed Using Changes in Measurements in Salivary Oxytocin(Compare changes between baseline and week 6 (end of treatment).)
- To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Wellbeing Using the Office for National Statistics Wellbeing Scale (ONS):(Compare changes between baseline and weeks 3, 6, 16, 32.)
- To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Anxiety, Using the State-Trait Anxiety Scale (STAI)(Compare changes between baseline and weeks 3, 6, 16, 32.)
- To Ascertain Whether Online Singing Improves the Observed Mother-infant Interaction Using the Crittenden CARE-Index (CCI)(Compare changes between baseline and week 6)
- To Ascertain Whether Online Singing Improves the Perceived Mother-infant Relationship Using the Maternal Postpartum Attachment Scale (MPAS)(Compare changes between baseline and weeks 6 and 32.)
- To Ascertain Whether Online Singing Improves the Perceived Mother-infant Relationship Using the Parent Reflective Functioning Questionnaire (PRFQ)(Compare changes between baseline and weeks 6 and 32.)
- To Ascertain Whether Online Singing Improves Social Support and Reduces Loneliness Using the UCLA Loneliness Scale(Compare changes between baseline and weeks 3, 6, 16, 32.)
- To Ascertain Whether Online Singing Improves Social Support and Reduces Loneliness Using the Multidimensional Scale of Perceived Social Support (MSPSS)(Compare changes between baseline and weeks 3, 6, 16, 32.)
- To Identify Whether There Are Biological Mechanisms Underpinning the Psychological Outcomes Assessed Using Changes in Measurements in Stress Hormones, Including Diurnal Cortisol and Salivary Cytokines(Compare changes between baseline and week 6 (end of treatment).)
- To Identify How the Online Singing Sessions Affect the Lived Experience of Mothers With PND Using Focus Groups(Qualitative data collection at week 6 (end of intervention).)
- 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 6 (end of intervention).)