Community Singing Interventions for Postnatal Depression: a Hybrid Type II Effectiveness-implementation Trial

NCT04834622 | Unknown

• 2 other identifiers: 219425/Z/19/Z-PND278445
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Postnatal Depression

Outcome Measures

Primary Outcomes (2)

• To assess the effectiveness of group singing interventions on symptoms of postnatal depression using the Edinburgh Postnatal Depression Scale (EPDS)

  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.

  The primary outcome measure is change in EPDS total score between baseline and Week 10 (end of treatment).

• To assess the acceptability of the intervention using the Acceptability of Intervention Measure (AIM)

  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.

  The primary outcome implementation measure is acceptability collected at week 10 (end of treatment).

Secondary Outcomes (28)

• 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 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 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.

Study Arms (2)

Melodies for Mums

EXPERIMENTAL

Mothers will start a block of 10-week classes and continue with their group for the duration of the course. Classes will take place in Children's Centres (or online). Mothers will attend with their babies and will sit in a socially-distanced circle on the floor surrounded by soft play cushions and mats. Classes will start with welcome songs, introducing everyone to one another, and involve a range of singing and music activities. Mothers will be required to respect social distancing guidelines. Music activities will include learning songs from around the world and will be accompanied by instruments that the mothers and babies can play together. Instruments will not be shared and will be disinfected before and after the singing sessions. Mothers will also work to write some of their own songs over the weeks. Recordings of the group singing the songs together will be made for the mothers to listen to at home. Classes will be led by professional workshop leaders trained by Breathe.

Behavioral: Melodies for Mums

Control (mother-baby community sessions)

ACTIVE COMPARATOR

Our control group will be a 'active' control. During the first 10 weeks (during the study period), mothers in the control group will receive details of other non-music classes available to them in the community (or online if necessary, depending on the programs available at the time and government guidelines) and will receive the same schedule of texts and phone calls to encourage them to join these activities. They will still be seen by the researchers to collect clinical measures and biological samples (including the pre-post saliva samples) and to monitor engagement in other activities. Following the first 10 weeks, the mothers in the control group will be offered a place on the singing programme, but these data will not be part of the study, and they will not join groups with women who are in the study

Behavioral: Control Community Sessions

Interventions

Melodies for Mums BEHAVIORAL

Melodies for Mums (M4M) is an intervention that was 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 their babies delivered in groups of 8-12 in Children's Centres for 10 weeks. A trained artist delivers 1-hour long singing sessions to mothers with postnatal depression (and their babies) for a period of 10-weeks. The sessions are aimed at the mothers, with songs ranging from sound baths to folk songs and songs created by the mothers themselves. Mothers randomised to the intervention will be prompted via text message, each week before the session, to attend these singing sessions.

Melodies for Mums

Control Community Sessions BEHAVIORAL

Group mother-baby interventions in the community (i.e. baby play, baby reading sessions, baby massage, etc). A list of these activities will be collected from the activities on offer in the community. All the mothers randomised to the control group will be pointed towards these activities, prompted by text messages in line with the prompts received by the mothers in the intervention group. Mothers will be encouraged to attend these non-music based community activities once a week with their babies.

Control (mother-baby community sessions)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• King's College London: lead
• University College, London: collaborator

Study Sites (1)

Maurice Wohl Clinical Neuroscience Institute, 5 Cutcombe Rd, Brixton, London SE5 9RT

London, SE5 9RT, United Kingdom

RECRUITING

Related Publications (4)

• Bind RH, Lawrence AJ, Estevao C, Hazelgrove K, Priestley K, Rebecchini L, Laijawala R, Miller C, Healey A, Agwuna J, Sevdalis N, Bakolis I, Davis R, Lopez MB, Woods AJ, Crane N, Manoharan M, Burton A, Dye H, Osborn T, Greenwood L, Perkins R, Dazzan P, Fancourt D, Pariante CM. Clinical effectiveness, implementation effectiveness and cost-effectiveness of a community singing intervention for postnatal depressive symptoms, SHAPER-PND: randomised controlled trial. Br J Psychiatry. 2025 Dec;227(6):836-845. doi: 10.1192/bjp.2025.10377. Epub 2025 Oct 15.

  PMID: 41087020 DERIVED

• Han E, Davis R, Soukup T, Bradbury A, Williams J, Baldellou Lopez M, Greenwood L, Bind R, Estevao C, Osborn T, Dye H, Priestley K, Rebecchini L, Hazelgrove K, Manoharan M, Woods A, Crane N, Healey A, Dazzan P, Sevdalis N, Pariante CM, Fancourt D, Bakolis I, Burton A. Implementation of singing groups for postnatal depression: experiences of participants and professional stakeholders in the SHAPER-PND randomised controlled trial. Front Health Serv. 2025 Jul 4;5:1582517. doi: 10.3389/frhs.2025.1582517. eCollection 2025.

  PMID: 40689271 DERIVED

• 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.

  PMID: 35105591 DERIVED

• 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.

  PMID: 34789494 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Carmine M Pariante

  King's College London - IoPPN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Estevao, PhD

CONTACT

020 7848 0531; shaperpnd@kcl.ac.uk

Rebecca Bind, PhD

CONTACT

020 7848 5450; rebecca.bind@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: April 8, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 8, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: To be submitted for publication in the next 2 weeks.
• Access Criteria: Open-access.

Locations

GB (1)