Clinical trial NCT04834622: Community Singing Interventions for Postnatal Depression: a Hybrid Type II Effectiveness-implementation Trial
Official title: Community Singing Interventions for Postnatal Depression: a Hybrid Type II Effectiveness-implementation Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postnatal Depression
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2021-04-08
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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 the event of the artist or the Breathe officer having to self-isolate, a replacement Breathe-trained artist will be ready to step-in and deliver the sessions. The same will apply to Breathe staff; there will be another staff member available to be present at the sessions.

The aims are to explore the clinical effectiveness of the intervention in a larger sample size than previous studies for scalability (to ascertain whether the initial findings can be replicated at a larger scale) and to explore the implementation effectiveness of the intervention, including its uptake, suitability, acceptability, appropriateness and feasibility (to identify not just 'if' but also 'why' the intervention works and support our understanding). It will also explore the cost effectiveness of the intervention, including the cost of delivering the interventions and the balance of benefit for the health sector, in order to be able to develop strong business plan for the intervention.

Participants and Recruitment process: This study aims to recruit 400 women (and their babies) that meet criteria on the Structured Clinical Interview for DSM-IV Disorders (SCID) for major depressive disorder and score equal to or above 10 on the Edinburgh Postnatal Depression Scale (EPDS). Participants will be recruited through clinic and the community (including study advertisement on social media, patient groups and self-referral). In order to recruit a sufficient number of women for this study in the current pandemic, most of the signposting will be done through GPs, midwives, health visitors and community mental health teams that remain engaged with the population despite the pandemic. In addition, signposting via social media, especially targeted advertising in local women's groups will be another valuable route for recruitment.

The women will be explained the trial, given the PIS and ICF and if consented, will be randomised (2:1) to an intervention group (M4M singing sessions) or a control group (other community-based mother and baby activities). This group will be involved in the clinical and the implementation effectiveness of the study. In addition, circa 30-50 wider stakeholders involved in the intervention will be recruited by research staff. This group includes artists, psychiatrists, GPs, health visitors, commissioners and others involved in the delivery of the intervention. The wider stakeholders and mothers involved in implementation science research will be provided with a specific ICF and a PIS.

Measures collected: Measures will be collected from both the intervention and control groups. Participants will be visited at their homes (or online via Zoom if necessary) for baseline/week 0 and week 10 assessments. Week 6, 20 and 36 visits will be completed online due to the self-reporting nature of the measures to be captured. If a mother cannot access a computer/laptop to complete the online questionnaires, these will be printed and posted to them.

In order to allow for flexibility in the schedule, a +/-1 week variation in the date of collection of the measures below (apart from week 10, when the window will be weeks 10-12) will be accepted. These measures will be collected from the control and the intervention groups simultaneously. The following measures will be collected:

Week 0 (screening/baseline): baseline demographics, repeated demographics, Brief Life Events Scale, Child Experience of Care and Abuse (CECA-Q), Composite Abuse Scale (CAS) - Pregnancy Version, Intrusive Life Events Scale; Structured Clinical Interview for DSM-IV (SCID), Edinburgh Postnatal Depression Scale (EPDS), Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory (BDI), Office for National Statistics Wellbeing Scale (ONS), State Trait Anxiety Inventory (STAI), Perceived Stress Scale (PSS); CARE-index, Maternal Postpartum Attachment Scale (MPAS), Parent Reflective Functioning Questionnaire (PRFQ), UCLA Loneliness Scale, Short General Self-Efficacy Scale (G, SE-6), Multidimensional Scale of Perceived Social Support (MSPSS); Diurnal saliva samples in mothers and babies.

Week 1: Pre-post session saliva samples in mothers and babies. Week 6: Repeated demographics, EPDS, BDI, ONS, STAI, PSS, MPAS, UCLA Loneliness Scale, GSE-6, MSPSS, Pre-post session saliva samples in mothers and babies.

Week 10: Repeated demographics, EPDS, HRDS, BDI, ONS, STAI, PSS, CARE-Index, MPAS, PRFQ, UCLA Loneliness Scale, GSE-6, MSPSS, Pre-post session saliva samples in mothers and babies, Diurnal saliva samples in mothers and babies, Hair cortisol sample, focus groups (qualitative research).

Week 20: Repeated demographics, EPDS, BDI, ONS, STAI, PSS, MPAS, UCLA Loneliness Scale, GSE-6, MSPSS.

Week 36: Repeated demographics, EPDS, BDI, ONS, STAI, PSS, CARE-Index, MPAS, PRFQ, UCLA Loneliness Scale, GSE-6, MSPSS.

Collection, transportation and storage of samples: Pre-post session saliva samples collected at sessions from mothers and babies will be retrieved using passive drooling (mothers) or salivettes (babies) and transported by one of the researchers in the team and used for cortisol, oxytocin, cytokines and other stress hormones analysis. The samples will be kept on ice and brought to the Maurice Wohl Clinical Neuroscience Institute (King's College London, Denmark Hill) to be stored at -80 degree C until analysis.

Six saliva samples from mothers (and two samples from their baby, providing consent) will be collected by mothers at home at awakening, +15, +30+ and +60 min after awakening, at 12 noon and 8 pm, and used for diurnal cortisol and other stress hormones. They will be kept in the fridge at home, and then posted or transported to the Maurice Wohl Clinical Neuroscience Institute (King's College London, Denmark Hill), to be stored at -20⁰C until analysis.

Hair samples will be kept at room temperature for short-term storage but will be transferred to -20⁰C for longer-term storage, until analysis (cortisol and other stress hormones) is conducted.

Samples will be processed, analysed and remaining material will be kept for 10 years after completion of the study. Results will be identified according to anonymised codes and stored securely.

Follow-up: Follow-up will be done at weeks 20 and 36, using the questionnaires mentioned above. Participants' wellbeing will be monitored through the questionnaires and any issues will be flagged by the KCL or UCL team or by Breathe that will do onward reporting if needed. No samples will be collected at follow-up.

Wider stakeholders: a series of questionnaires/interviews will be performed to collect implementation science data only.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Child outside of the age-range specified
* Unable to give informed consent

Primary outcomes:
measure: To assess the effectiveness of group singing interventions on symptoms of postnatal depression using the Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: The primary outcome measure is change in EPDS total score between baseline and Week 10 (end of treatment).
measure: To assess the acceptability of the intervention using the Acceptability of Intervention Measure (AIM)
timeFrame: The primary outcome implementation measure is acceptability collected at week 10 (end of treatment).
Secondary outcomes:
measure: To assess whether singing improves (changes) further aspects of mental health, including depression using the Hamilton Depression Rating Scale (HDRS).
timeFrame: Compare change between baseline and weeks 6, 10, 20 and 36.
measure: To assess whether singing improves (changes) further aspects of mental health, including depression using the Beck Depression Inventory (BDI).
timeFrame: Compare change between baseline and weeks 6, 10, 20 and 36.
measure: To assess whether singing improves (changes) further aspects of mental health, including stress using the Perceived Stress Scale (PSS)
timeFrame: Compare change between baseline and weeks 6, 10, 20 and 36.
measure: To assess whether singing improves (changes) further aspects of mental health, including wellbeing using the Office for National Statistics Wellbeing Scale (ONS):
timeFrame: Compare change between baseline and weeks 6, 10, 20 and 36.
measure: To assess whether singing improves (changes) further aspects of mental health, including anxiety, using the State-Trait Anxiety Scale (STAI)
timeFrame: Compare change between baseline and weeks 6, 10, 20 and 36.
measure: To ascertain whether singing improves the observed mother-infant interaction using the Crittenden CARE-Index (CCI)
timeFrame: Compare change between baseline and weeks 10 and 36.
measure: To ascertain whether singing improves the perceived mother-infant relationship using the Maternal Postpartum Attachment Scale (MPAS)
timeFrame: Compare change between baseline and weeks 6, 10, 20 and 36.
measure: To ascertain whether singing improves the perceived mother-infant relationship using the Parent Reflective Functioning Questionnaire (PRFQ)
timeFrame: Compare change between baseline and weeks 6, 10, 20 and 36.
measure: To ascertain whether singing improves social support and reduces loneliness using the UCLA Loneliness Scale
timeFrame: Compare change between baseline and weeks 6, 10, 20 and 36.
measure: To ascertain whether singing improves social support and reduces loneliness using the Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Compare change between baseline and weeks 6, 10, 20 and 36.
measure: 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
timeFrame: Compare change between week 1 and weeks 6 and 10.
measure: To identify whether there are biological mechanisms underpinning the psychological outcomes assessed using changes in measurements in salivary oxytocin
timeFrame: Compare change between week 1 and weeks 6 and 10.
measure: To identify how the singing sessions affect the lived experience of mothers with PND using focus groups
timeFrame: Qualitative data collection at week 10 (end of intervention).
measure: 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
timeFrame: Qualitative data collection at week 10 (end of intervention).
measure: To assess the acceptability of the intervention using the Intervention Measure (AIM)
timeFrame: Quantitative data collection at week 10 (end of intervention).
measure: To assess reasons for perceived acceptability of the intervention using semi-structured interviews
timeFrame: Qualitative data collection at week 10 (end of intervention).
measure: To assess uptake/reach of the intervention using recruitment rate records
timeFrame: Quantitative data collection at week 10 (end of intervention).
measure: To assess the appropriateness of the intervention using Intervention Appropriateness Measure (IAM)
timeFrame: Qualitative data collection at week 10 (end of intervention).
measure: To assess the appropriateness of the intervention using semi-structured interviews
timeFrame: Qualitative data collection at week 10 (end of intervention).
measure: To assess the feasibility of the intervention using the Feasibility of Intervention Measure (FIM)
timeFrame: Quantitative data collection at week 10 (end of intervention).
measure: To assess the feasibility of the intervention using semi-structured interviews
timeFrame: Quantitative data collection at week 10 (end of intervention).
measure: To assess intervention adherence and attrition rates using attendance data (rates and drop out reasons)
timeFrame: Quantitative data collection at week 10 (end of intervention).
measure: To assess the adoption of the intervention using participants and stakeholder enrollment rates
timeFrame: Quantitative data collection at week 10 (end of intervention).
measure: To assess the cost effectiveness of the intervention using the 5-level EQ-5D version (EQ5D-5L)
timeFrame: Quantitative and qualitative data collection at week 10 (end of intervention).
measure: To assess the cost effectiveness of the intervention using the Adult Service Use Schedule (AD-SUS)
timeFrame: Quantitative and qualitative data collection at week 10 (end of intervention).
measure: To assess the cost effectiveness of the intervention using implementation activity logs (to estimate implementation costs).
timeFrame: Quantitative and qualitative data collection at week 10 (end of intervention).
measure: To assess factors affecting the sustainability and scalability of the intervention using the NOMAD Scale:
timeFrame: Quantitative and qualitative data collection at week 10 (end of intervention).
measure: To assess factors affecting the sustainability and scalability of the intervention using semi-structured interviews
timeFrame: Quantitative and qualitative data collection at week 10 (end of intervention).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Maurice Wohl Clinical Neuroscience Institute, 5 Cutcombe Rd, Brixton, London SE5 9RT
Study officials:
affiliation: King's College London - IoPPN
name: Carmine M Pariante
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soukup T, Davis RE, Baldellou Lopez M, Healey A, Estevao C, Fancourt D, Dazzan P, Pariante C, Dye H, Osborn T, Bind R, Sawyer K, Rebecchini L, Hazelgrove K, Burton A, Manoharan M, Perkins R, Podlewska A, Chaudhuri R, Derbyshire-Fox F, Hartley A, Woods A, Crane N, Bakolis I, Sevdalis N. Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease. BMJ Open. 2022 Feb 1;12(2):e055691. doi: 10.1136/bmjopen-2021-055691.
citation: Estevao C, Bind R, Fancourt D, Sawyer K, Dazzan P, Sevdalis N, Woods A, Crane N, Rebecchini L, Hazelgrove K, Manoharan M, Burton A, Dye H, Osborn T, Davis RE, Soukup T, Arias de la Torre J, Bakolis I, Healey A, Perkins R, Pariante C. SHAPER-PND trial: clinical effectiveness protocol of a community singing intervention for postnatal depression. BMJ Open. 2021 Nov 17;11(11):e052133. doi: 10.1136/bmjopen-2021-052133.