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:
1. 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;
2. 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
3. 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.
Recruitment will be primarily done through:
* Posters and flyers in baby weigh clinics and other community and clinical centres for postnatal mothers and their babies, if lockdown rules allow that;
* Signposting via other health and social care professionals and in the community via email contacts;
* Social media/online forums
* Self-referral following general advertisement Community services will be made aware of the study through a poster/flyer/e-mail campaign sent directly to them. Breathe has a database of contacts used to recruit for Breathe's Melodies for Mums in-person programme that will be used for this purpose.
In terms of social media recruitment, the following will be used: various Facebook targeted groups, Instagram \& Twitter hashtags to find groups and forums to promote to, plus more traditional routes e.g. to get local authorities to advertise as part of their various tiers of information of available local services.
The first contact will be done by Breathe Arts staff over the phone, following social media/online self-referral/direct self-referral through posters/flyers in community and clinical centres. The research team will only become involved once the potential participants have made contact with the Breathe Arts team, completed an online screening form and given consent for the basic information collected onto the online screening (personal information, EPDS score) to be shared with the research team.
All potential participants will initially be directed to a pre-screening online form on Breathe's website. This will capture basic information including the mother's name, date of birth (DOB), baby's DOB, address, telephone number, and once this has been submitted, they will be sent EPDS scale to complete. Women will be asked to read an online participant information sheet (PIS) and to electronically confirm consent after reading the informed consent form (ICF) to their personal data being collected. The PIS will explain that their details will be used for further contact related to the trial in case their EPDS score is equal or higher than 10.
If a woman's EPDS score is lower than 10, she will receive a notification that she is not currently eligible to participate and will receive information on other support services in the meantime. In the consent form, it will be asked if she would like to be re-contacted at a future date when the next series of workshops is scheduled, and if she agrees, she will be contacted in the same way as other women who express interest for the first time and screened again. Researchers will wait at least 1 month before inviting re-screening.
If a woman's score is 10 or higher, she will be notified that she is potentially eligible and when a new round of 6 singing sessions becomes available, the research team will arrange a call to undertake the full screening interview against the inclusion/exclusion criteria. This full screening will take place in the 2 full weeks prior to the online classes starting (referred to as 'Baseline'). If the participant is found to be non-eligible, they will be given information for other support services. If the participant is found to be eligible the researcher will carry out the baseline measures. A contact point will be made available for participants in case they wish to ask further questions regarding the trial. If more women are found to be eligible for each 6-week programme than the sessions have capacity for, then priority will be given to those with the highest EPDS scores. The others will be invited to rescreen for the next group.
A copy of the ICF will be sent electronically to the participant once the baseline Zoom call has been arranged. The ICF will include a section detailing the samples to be collected (saliva) and others measures to be analysed, as well as the consent to obtain babies' data (in video and other formats) and babies' saliva samples throughout the study (see full table for more information on measures in section 9.7). A participant can opt out of the sample collections or babies' data collection and enter the trial for all other measures. The Informed consent will also include a point stating that the participants might be contacted for further studies. This will allow for the sample of the population enrolled on the trial to be approached for future follow-up research questions.
Recruitment of deliverers:
During the course of the study, deliverers will be recruited by the research team from the pool of 1-3 artists trained by Breathe that deliver the M4M sessions. Researchers will approach deliverers to ascertain their interest level in participating in our study. Deliverers will be recruited for the purpose of assessing the ways in which this 6-week online singing programme can ameliorate mothers' postnatal depression.
If deliverers express interest, researchers will provide them with the Deliverer participant information sheet, which will explain to them why the researchers are interested in incorporating deliverer feedback on the programme into our study, and will explain what kind of information the researchers are looking to collect from them. The researchers will then electronically provide deliverers who are interested with the deliverer informed consent form to consent to their personal data being collected.
The ICF will explain that data will be collected and stored confidentially, and will have the option to opt-in to each consent point.
If deliverers consent, the UCL researcher will arrange a Zoom call with them, during which the researchers will interview them and collect feedback on how they felt the programme helped women's postnatal depression, with the aim to use their views/experiences to help inform upon the development of the programme.
Safeguarding
The research teams will have three safeguarding check points:
1. The UCL research team will check the EPDS scores of all participants as they come through online (baseline, 3, 6, 16 and 32 weeks) at least once a week, and they will alert the clinical leads of the study if (a) EPDS scores are more than 25 out of 30 or, (b) EPDS includes a score of 2 or more on the self-harm question.
2. Breathe will report to the KCL research team on any concerns during intervention sessions within 24 hours of noting the concern, especially if the behaviour is felt to be indicative that they are at immediate risk of harming themselves or their babies.
3. If the research team thinks that the behaviour (or any responses to the questionnaires collected) of any participant during the online assessments or during any other contact (e.g. phone contact), is felt to be indicative that they are at immediate risk of harming themselves or their babies or others, the same process will be taken.
The clinical leads (the perinatal psychiatrists) on the research team will assess each report and decide whether there is a need to contact a participant, alert a participant's GP or contact any other healthcare services. This decision will be made within 72 hours of receiving the report. Participants will be informed of this process in the PIS. If contact with a health professional is being made on behalf of a participant, the participant will be informed that this is taking place.
Assessments Participants will be assessed via Zoom for baseline, week 6 and week 32 assessments. Week 3 and 16 assessments will be completed online by the mothers only, due to the self-reporting nature of the measures. It is expected that all mothers will have access to an internet-enabled device, as this is an essential inclusion criterion. For baseline online measures, participants will be encouraged to complete these a day either side of the first session. For week 3 measures, participants will be encouraged to complete these within 3 days of the session. However, in order to allow flexibility in the schedule, a +/-1 week variation in the date of collection of the measures will be accepted (apart from week 6, when the window will be weeks 6-8).
Individual qualitative interviews with a sub sample of women will take place after the final session of the intervention either by telephone or video call. Interviews will also be conducted with the intervention deliverers/singing group leaders, the deliverers. The interviews will explore the experiences, mechanisms of effect, barriers and facilitators to taking part and delivering online singing groups.
Sample collection and transportation Participants can opt out of sample collection at any stage of the study. Samples will be labelled according to participant ID allocated at randomisation so that the samples will not be directly linked to any personal data.
All saliva samples will be collected by Salivette absorbent swabs for adults and SalivaBio Children's Swabs for babies and used to measure cortisol levels. Mothers will be asked to collect samples to measure diurnal cortisol rhythm and cortisol reactivity to the sessions.
For diurnal samples, mothers will be asked to collect six saliva samples from themselves (awakening, +15, +30+ and +60 min after awakening, at 12 noon and 8 pm), and two samples from their baby (awakening and 8pm). Mothers will be asked to collect these samples up to 3 days prior to their session (baseline, week 3 and week 6), however, in order to allow flexibility in the schedule, a +/-5 day variation will be accepted in the date of collection. The investigators have extensively experience with this methodology and successfully collected such data before.
Mothers will also be asked to collect saliva samples from themselves and their baby immediately before and after their session (week 1, week 3 and week 6).
Mothers will be provided with pre-paid envelopes in which to return both diurnal and session samples together for each time point. All samples should be kept in the mother's fridge until ready to return by post.
Follow-up data collection Upon termination of the 6 weekly sessions, participants will be contacted to complete follow-up questionnaires around weeks 16 and 32. An additional virtual assessment will be carried out around week 32. A sub sample of women will be invited to take part in a qualitative interview about their experiences of receiving the online intervention up to two weeks after their final intervention session.
