Online Singing Interventions for Postnatal Depression in Times of Social Isolation: a Single Arm Study

NCT04857593 | Completed Results

• 1 other identifier: 219425/Z/19/Z-PNDO
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postnatal Depression; Social Isolation

Keywords

singing; depression; music; social isolation; anxiety; postnatal; mental health; perinatal

Outcome Measures

Primary Outcomes (1)

• To Assess the Effectiveness of Online Group Singing Interventions on Symptoms of Postnatal Depression Using the Edinburgh Postnatal Depression Scale (EPDS)

  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.

  The primary outcome measure is changes in EPDS total score between baseline and Week 6 (end of treatment).

Secondary Outcomes (14)

• 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 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 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.

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Behavioral: Melodies for Mums

Interventions

Melodies for Mums BEHAVIORAL

Classes start with a chat between mothers and the artist. The singing session will include welcome songs, introducing the babies and mothers to one another, and then involve a range of singing and music activities. These will include learning songs from around the world, ranging from short vocal exercises that use "motherese" style noises and sound effects (including sound baths where the mothers sang a sustained note providing a relaxation technique), to simple lullabies that can be picked up very quickly and sung in basic harmonies or rounds, to longer or more complex songs that will be learnt gradually over the weeks. Instruments such as guitar and ukulele will also be used by the artist for a small number of songs. Mothers will also work to write some of their own songs over the weeks, developing lyrics together about their babies or experiences of motherhood and creating simple melodies. Classes will be led by workshop leaders trained by Breathe, with support of assistants.

Intervention

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 EPDS.

You may not qualify if:

• 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
• Unable

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, London, SE5 9RT, United Kingdom

Location

Related Publications (5)

• Fancourt D, Perkins R. Effect of singing interventions on symptoms of postnatal depression: three-arm randomised controlled trial. Br J Psychiatry. 2018 Feb;212(2):119-121. doi: 10.1192/bjp.2017.29.

  PMID: 29436333 BACKGROUND

• Green P. Risks to children and young people during covid-19 pandemic. BMJ. 2020 Apr 28;369:m1669. doi: 10.1136/bmj.m1669. No abstract available.

  PMID: 32345583 BACKGROUND

• Fancourt D, Steptoe A. Present in Body or Just in Mind: Differences in Social Presence and Emotion Regulation in Live vs. Virtual Singing Experiences. Front Psychol. 2019 Apr 10;10:778. doi: 10.3389/fpsyg.2019.00778. eCollection 2019.

  PMID: 31024405 BACKGROUND

• Bind RH, Sawyer K, Hazelgrove K, Rebecchini L, Miller C, Ahmed S, Dazzan P, Sevdalis N, Bakolis I, Davis R, Lopez MB, Woods A, Crane N, Manoharan M, Burton A, Dye H, Osborn T, Greenwood L, Perkins R, Fancourt D, Pariante CM, Estevao C. Feasibility, clinical efficacy, and well-being outcomes of an online singing intervention for postnatal depression in the UK: SHAPER-PNDO, a single-arm clinical trial. Pilot Feasibility Stud. 2023 Jul 27;9(1):131. doi: 10.1186/s40814-023-01360-9.

  PMID: 37501172 DERIVED

• Bind RH, Estevao C, Fancourt D, Hazelgrove K, Sawyer K, Rebecchini L, Miller C, Dazzan P, Sevdalis N, Woods A, Crane N, Manoharan M, Burton A, Dye H, Osborn T, Greenwood L, Bakolis I, Lopez MB, Davis R, Perkins R, Pariante CM. Online singing interventions for postnatal depression in times of social isolation: a feasibility study protocol for the SHAPER-PNDO single-arm trial. Pilot Feasibility Stud. 2022 Jul 18;8(1):148. doi: 10.1186/s40814-022-01112-1.

  PMID: 35851430 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Social Isolation; Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Social Behavior; Behavior; Behavioral Symptoms; Personal Satisfaction

Results Point of Contact

• Title: Professor Carmine Pariante
• Organization: King's College London

carmine.pariante@kcl.ac.uk

020 78480807

Study Officials

• Carmine M Pariante

  King's College London - IoPPN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 23, 2021
• Study Start: January 4, 2021
• Primary Completion: March 31, 2022
• Study Completion: September 30, 2022
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months and ending 36 months following article publication.
• Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

GB (1)