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Online Singing Interventions for Postnatal Depression in Times of Social Isolation: a Single Arm Study (SHAPER-PNDO)

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ClinicalTrials.gov Identifier: NCT04857593
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
King's College London

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.

Condition or disease Intervention/treatment Phase
Postnatal Depression Social Isolation Behavioral: Melodies for Mums Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Online Singing Interventions for Postnatal Depression in Times of Social Isolation: a Single Arm Study
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Melodies for Mums
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.




Primary Outcome Measures :
  1. To assess the effectiveness of online group singing interventions on symptoms of postnatal depression using the Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 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.



Secondary Outcome Measures :
  1. To assess whether online singing improves (changes) further aspects of mental health, including depression using the Hamilton Depression Rating Scale (HDRS) [ Time Frame: 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:

    Hamilton Depression Rating Scale (HDRS): is a semi-structured clinician-administered depression assessment scale. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.


  2. To assess whether online singing improves (changes) further aspects of mental health, including depression using the Beck Depression Inventory (BDI). [ Time Frame: 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:

    Beck Depression Inventory (BDI): is a 21-item, self-rated scale that evaluates key symptoms of depression. Each item is rated 0-3, whereby a higher score indicates more severe depression. 1-10 is considered normal; 11-16 is mild mood disturbance; 17-20 is borderline clinical depression; 21-30 is moderate depression; 31-40 is severe depression; 40 and above is extreme depression.


  3. To assess whether online singing improves (changes) further aspects of mental health, including stress using the Perceived Stress Scale (PSS) [ Time Frame: Compare changes between baseline and weeks 3, 6, 16, 32. ]

    To assess whether online singing improves (changes) further aspects of mental health, including stress.

    Stress will be evaluated using the following scale:

    Perceived Stress Scale (PSS): is an 11-item questionnaire assessing one's perceived stress levels. Each question must be answered on a likert scale, ranging from 'never' (0) to 'very often', (5), whereby a higher score indicates greater stress.


  4. To assess whether online singing improves (changes) further aspects of mental health, including wellbeing using the Office for National Statistics Wellbeing Scale (ONS): [ Time Frame: Compare changes between baseline and weeks 3, 6, 16, 32. ]

    Wellbeing will be evaluated using the following scale:

    Office for National Statistics Wellbeing Scale (ONS): is a four-item questionnaire assessing life satisfaction, worthwhile, happiness, and anxiety. People are asked to respond to the questions on a scale from 0 to 10 where for life satisfaction/worthwhile/happiness a higher score indicates greater wellbeing, and for anxiety a greater score indicates greater anxiety.


  5. To assess whether online singing improves (changes) further aspects of mental health, including anxiety, using the State-Trait Anxiety Scale (STAI) [ Time Frame: Compare changes between baseline and weeks 3, 6, 16, 32. ]

    Anxiety will be evaluated using the following scale:

    State-Trait Anxiety Scale (STAI): is a self-rated questionnaire which assesses intensity or frequency of anxiety. It is divided into two sections, one measuring 'state' and the other 'trait' of anxiety. The range of possible scores for each section is 20 to 80, whereby a higher score indicates greater anxiety. A cut-off score of at least 40 has been considered to be clinically meaningful.


  6. To ascertain whether online singing improves the observed mother-infant interaction using the Crittenden CARE-Index (CCI) [ Time Frame: Compare changes between baseline and week 6 ]

    To assess whether the online singing intervention improves upon aspects of the mother-infant relationship.

    The observed mother-infant interaction will be assessed using:

    Crittenden CARE-Index (CCI): The CCI is a validated tool to clinically assess the mother-infant interaction. Videos are filmed of a mother and her baby playing, and are rated from 0-14 for aspects of maternal behaviour, aspects of infant behaviour, and dyadic synchrony, whereby a higher score indicates greater amounts of that behaviour present.


  7. To ascertain whether online singing improves the perceived mother-infant relationship using the Maternal Postpartum Attachment Scale (MPAS) [ Time Frame: Compare changes between baseline and weeks 6 and 32. ]

    To assess whether the online singing intervention improves upon aspects of the mother-infant relationship.

    The perceived mother-infant relationship will be assessed using:

    Maternal Postpartum Attachment Scale (MPAS): The MPAS is a 19-item questionnaire assessing maternal feelings of attachment and bonding towards her baby. Items are rated from 1 to 5, whereby a lower score indicates less bonding/attachment with her baby.


  8. To ascertain whether online singing improves the perceived mother-infant relationship using the Parent Reflective Functioning Questionnaire (PRFQ) [ Time Frame: Compare changes between baseline and weeks 6 and 32. ]

    To assess whether the online singing intervention improves upon aspects of the mother-infant relationship.

    The perceived mother-infant relationship will be assessed using:

    Parent Reflective Functioning Questionnaire (PRFQ): The PRFQ is an 18-item questionnaire that asks mothers to reflect on their relationship with their infant and how attuned they perceive themselves to be. It assesses a caregiver's capability to reflect upon her own internal mental experiences as well as those of the baby. Each item is rated on a likert scale from 1 (strongly disagree) to 7 (strongly agree) with a total possible score ranging from 18-126.


  9. To ascertain whether online singing improves social support and reduces loneliness using the UCLA Loneliness Scale [ Time Frame: Compare changes between baseline and weeks 3, 6, 16, 32. ]

    To assess whether the online singing intervention improves aspects of loneliness and perceived support.

    UCLA Loneliness Scale: is a 20-item questionnaire that assesses one's perceived sense of loneliness. Questions address relationships and loneliness. Items are rated as 'often,' 'sometimes,' 'rarely,' or 'never.' Scores can range from 20-80, whereby a higher score indicates a greater sense of loneliness.


  10. To ascertain whether online singing improves social support and reduces loneliness using the Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Compare changes between baseline and weeks 3, 6, 16, 32. ]

    To assess whether the online singing intervention improves aspects of loneliness and perceived support.

    Multidimensional Scale of Perceived Social Support (MSPSS): is a 12-item questionnaire that assesses perceived support (practical and emotional) from peers, family, and friends. Each item is rated from 1 (very strongly disagree) to 7 (very strongly agree) and is scored from 12-84, where a higher score indicates a greater sense of perceived social support.


  11. 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 [ Time Frame: Compare changes between baseline and week 6 (end of treatment). ]
    Stress hormones, including diurnal cortisol and salivary cytokines. These measures will be analysed using an array of techniques including enzyme-linked immunosorbent assay (ELISA). Higher levels of cortisol and cytokines may indicate higher levels of stress.

  12. To identify whether there are biological mechanisms underpinning the psychological outcomes assessed using changes in measurements in salivary oxytocin [ Time Frame: Compare changes between baseline and week 6 (end of treatment). ]
    Levels of salivary oxytocin measured. These measures will be analysed using an array of techniques including enzyme-linked immunosorbent assay (ELISA). Higher levels of oxytocin may indicate positive interactions between mothers and babies.

  13. To identify how the online singing sessions affect the lived experience of mothers with PND using focus groups [ Time Frame: Qualitative data collection at week 6 (end of intervention). ]
    Focus groups: focus groups will take place immediately following session 6 (if logistically possible) for all mothers focusing on their lived experience of the intervention and their reported mechanisms of effect

  14. 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 [ Time Frame: Qualitative data collection at week 6 (end of intervention). ]
    Semi structured interviews: individual or small-group interviews with three sub-groups of women self-reporting particular risk factors for PND: traumatic birth, adverse childhood experiences, and social isolation/loneliness. These interviews will focus in-depth on the phenomenology of PND and how singing intersects with the specific context of PND among the sub-groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 EPDS.

Exclusion Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857593


Contacts
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Contact: Rebecca Bind 020 7965 7389 rebecca.bind@kcl.ac.uk
Contact: Ana Carolina B Estevao 020 7965 7389 carolina.estevao@kcl.ac.uk

Locations
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United Kingdom
Maurice Wohl Clinical Neuroscience Institute, 5 Cutcombe Rd, Brixton, London SE5 9RT Recruiting
London, United Kingdom, SE5 9RT
Contact: Carolina Estevao, PhD    020 7965 7389    carolina.estevao@kcl.ac.uk   
Sponsors and Collaborators
King's College London
University College, London
Investigators
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Principal Investigator: Carmine M Pariante King's College London - IoPPN
  Study Documents (Full-Text)

Documents provided by King's College London:
Publications:
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04857593    
Other Study ID Numbers: 219425/Z/19/Z-PNDO
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
singing
depression
music
social isolation
anxiety
postnatal
mental health
perinatal
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications