Trial Outcomes & Findings for Online Singing Interventions for Postnatal Depression in Times of Social Isolation: a Single Arm Study (NCT NCT04857593)
NCT ID: NCT04857593
Last Updated: 2025-11-26
Results Overview
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.
COMPLETED
NA
37 participants
The primary outcome measure is changes in EPDS total score between baseline and Week 6 (end of treatment).
2025-11-26
Participant Flow
Participant milestones
| Measure |
Intervention
M4M online is a 6-week intervention for mothers with PND.
* 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.
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.
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|---|---|
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Overall Study
STARTED
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37
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Overall Study
COMPLETED
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32
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Overall Study
NOT COMPLETED
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5
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number of participants we obtained measure from
Baseline characteristics by cohort
| Measure |
M4M Intervention
n=37 Participants
We modified the original face-to-face intervention for this online study as follows:
Groups were up to 15 women (in line with the community M4M) to ensure all participants were visible on one screen and thus create a stronger sense of community and connection.
The intervention was 6 weeks long, based on the face-to-face intervention evidence that by 6 weeks, there is already a significant improvement in depressive symptoms compared with control interventions.
Mothers were connected from week 2 of the intervention to an optional WhatsApp group, to mirror the social interaction component of the in-person community intervention.
Artists were trained centrally by Breathe to ensure that fidelity to the original M4M was maintained. Furthermore, a member of Breathe was present on each Zoom singing session to monitor and ensure the session was being delivered according to protocol. During the singing portion of the sessions, all participants were muted, while the artist was unmuted and playing background melodies, to ensure a group feeling while avoiding broadband-related sound delays and other background noises. Thus, participants could hear themselves, the artist, and the background melody, with pre-recorded voices, that recreated the community M4M setting. Outside of sessions, mothers had access to a weblink with M4M songs, to allow them to sing at home in between sessions and beyond M4M.
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Age, Continuous
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35.3 Years
STANDARD_DEVIATION 4.6 • n=37 Participants
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Sex: Female, Male
Female
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37 Participants
n=37 Participants
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Sex: Female, Male
Male
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0 Participants
n=37 Participants
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Race/Ethnicity, Customized
Maternal Ethnicity · White
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28 Participants
n=37 Participants
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Race/Ethnicity, Customized
Maternal Ethnicity · Ethnic minority groups
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9 Participants
n=37 Participants
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Region of Enrollment
United Kingdom
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37 participants
n=37 Participants
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Marital Status
Married/cohabiting
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34 Participants
n=37 Participants
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Marital Status
Single with/without partner
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3 Participants
n=37 Participants
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Biological Father Ethnicity
White
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26 Participants
n=36 Participants • Number of participants we obtained measure from
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Biological Father Ethnicity
Ethnic minority groups
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10 Participants
n=36 Participants • Number of participants we obtained measure from
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Maternal Qualifications
Higher education or above
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33 Participants
n=37 Participants
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Maternal Qualifications
GCSE/A-level or below
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4 Participants
n=37 Participants
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Maternal Employment Status
Employed/student/maternity leave
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32 Participants
n=37 Participants
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Maternal Employment Status
Unemployed/full-time mother
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5 Participants
n=37 Participants
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Partner Employment Status
Employed/student
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35 Participants
n=37 Participants
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Partner Employment Status
Missing
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2 Participants
n=37 Participants
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Household income
Less than £30,000
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2 Participants
n=37 Participants
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Household income
£30,000 or greater
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35 Participants
n=37 Participants
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Infant Age
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4 Months
STANDARD_DEVIATION 2.5 • n=37 Participants
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Infant Sex
Female
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18 Participants
n=37 Participants
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Infant Sex
Male
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19 Participants
n=37 Participants
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Attending Other Mother-Baby Groups
Yes
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17 Participants
n=37 Participants
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Attending Other Mother-Baby Groups
No
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20 Participants
n=37 Participants
|
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Childhood Experience of Abuse
Yes
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12 Participants
n=33 Participants • Number of participants we obtained measure from
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Childhood Experience of Abuse
No
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21 Participants
n=33 Participants • Number of participants we obtained measure from
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Adult Experience of Intimate Partner Violence
Yes
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15 Participants
n=37 Participants
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Adult Experience of Intimate Partner Violence
No
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22 Participants
n=37 Participants
|
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Intrusive Life Event Across Lifetime
Yes
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16 Participants
n=33 Participants • Number of participants we obtained measure from
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Intrusive Life Event Across Lifetime
No
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17 Participants
n=33 Participants • Number of participants we obtained measure from
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Threatening Life Event in Perinatal Period
Yes
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18 Participants
n=33 Participants • Number of participants we obtained measure from
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Threatening Life Event in Perinatal Period
No
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15 Participants
n=33 Participants • Number of participants we obtained measure from
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Current Diagnosis of MDD
Yes
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22 Participants
n=37 Participants
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Current Diagnosis of MDD
No
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15 Participants
n=37 Participants
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Lifetime Diagnosis of MDD
Yes
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28 Participants
n=37 Participants
|
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Lifetime Diagnosis of MDD
No
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9 Participants
n=37 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Singing group
n=37 Participants
This is a single-arm trial in which all participants are allocated to our online Melodies for Mums singing intervention.
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|---|---|
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To Assess the Effectiveness of Online Group Singing Interventions on Symptoms of Postnatal Depression Using the Edinburgh Postnatal Depression Scale (EPDS)
Mean EPDS score at baseline
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16.6 score on a scale
Standard Error 3.7
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To Assess the Effectiveness of Online Group Singing Interventions on Symptoms of Postnatal Depression Using the Edinburgh Postnatal Depression Scale (EPDS)
Mean EPDS score at week 6
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11.2 score on a scale
Standard Error 5.3
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SECONDARY outcome
Timeframe: Compare changes between baseline and weeks 6 (end of treatment).Population: Single-arm group who participated in online Melodies for Mums intervention
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 from 0-52 and is based on the 17-item scale, where each question receives a score from either 0-2 or 0-4, depending on the question. Total summed 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.
Outcome measures
| Measure |
Singing group
n=37 Participants
This is a single-arm trial in which all participants are allocated to our online Melodies for Mums singing intervention.
|
|---|---|
|
To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Depression Using the Hamilton Depression Rating Scale (HDRS)
Baseline
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13.8 units on a scale
Standard Error 6.3
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Depression Using the Hamilton Depression Rating Scale (HDRS)
Week 6
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7.4 units on a scale
Standard Error 6.8
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SECONDARY outcome
Timeframe: Compare changes between baseline and weeks 3, 6, 16, 32.Population: Change in Beck Depression Inventory score across entire study period (baseline, week 3, week 6, week 16, week 32) in single-arm group who received online Melodies for Mums singing intervention.
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. Total scores range from 0-63. Each item is rated 0-3, whereby a higher score indicates more severe depression. Scores from each question are summed to calculate the total score. 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.
Outcome measures
| Measure |
Singing group
n=37 Participants
This is a single-arm trial in which all participants are allocated to our online Melodies for Mums singing intervention.
|
|---|---|
|
To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Depression Using the Beck Depression Inventory (BDI).
Baseline
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18.9 score on a scale
Standard Error 6.6
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Depression Using the Beck Depression Inventory (BDI).
week 3
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15.1 score on a scale
Standard Error 7.5
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Depression Using the Beck Depression Inventory (BDI).
week 6
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13.0 score on a scale
Standard Error 8.6
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Depression Using the Beck Depression Inventory (BDI).
week 16
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12.3 score on a scale
Standard Error 8.4
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Depression Using the Beck Depression Inventory (BDI).
week 32
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11.6 score on a scale
Standard Error 8.1
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SECONDARY outcome
Timeframe: Compare changes between baseline and weeks 3, 6, 16, 32.Population: Change in Perceived Stress Scale score across entire study period (baseline, week 3, week 6, week 16, week 32) in single-arm group who received online Melodies for Mums singing intervention.
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 10-item questionnaire assessing one's perceived stress levels. Each question is scored 0-4 and totals from each question are summed to calculate total score, which can range from 0-40. Each question must be answered on a likert scale, ranging from 'never' (0) to 'very often', (4), whereby a higher score indicates greater stress.
Outcome measures
| Measure |
Singing group
n=37 Participants
This is a single-arm trial in which all participants are allocated to our online Melodies for Mums singing intervention.
|
|---|---|
|
To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Stress Using the Perceived Stress Scale (PSS)
Baseline
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29.0 score on a scale
Standard Error 5.7
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Stress Using the Perceived Stress Scale (PSS)
Week 3
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22.4 score on a scale
Standard Error 5.2
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Stress Using the Perceived Stress Scale (PSS)
Week 6
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19.7 score on a scale
Standard Error 5.3
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Stress Using the Perceived Stress Scale (PSS)
Week 16
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19.2 score on a scale
Standard Error 5.7
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Stress Using the Perceived Stress Scale (PSS)
Week 32
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19.1 score on a scale
Standard Error 6.1
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SECONDARY outcome
Timeframe: Compare changes between baseline and weeks 3, 6, 16, 32.Population: Change in Office for National Statistics Wellbeing Scale score between baseline and end of intervention
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 100 where for life satisfaction/worthwhile/happiness a higher score indicates greater wellbeing, and for anxiety a greater score indicates greater anxiety. Total scores can range from 0-100.
Outcome measures
| Measure |
Singing group
n=37 Participants
This is a single-arm trial in which all participants are allocated to our online Melodies for Mums singing intervention.
|
|---|---|
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Wellbeing Using the Office for National Statistics Wellbeing Scale (ONS):
Baseline life satisfaction
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50.0 score on a scale
Standard Error 23.0
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Wellbeing Using the Office for National Statistics Wellbeing Scale (ONS):
Week 6 life satisfaction
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72.8 score on a scale
Standard Error 11.7
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Wellbeing Using the Office for National Statistics Wellbeing Scale (ONS):
Baseline worthwhileness
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51.7 score on a scale
Standard Error 34.0
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To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Wellbeing Using the Office for National Statistics Wellbeing Scale (ONS):
Week 6 worthwhileness
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78.6 score on a scale
Standard Error 15.1
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SECONDARY outcome
Timeframe: Compare changes between baseline and weeks 3, 6, 16, 32.Population: Change in State Trait Anxiety Inventory score across entire study period (baseline, week 3, week 6, week 16, week 32) in single-arm group who received online Melodies for Mums singing intervention.
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. We have analysed the 'state' section of the STAI (STAI-S). The STAI-S consists of 20 questions, which can be scored from 1-4 and then summed. The range of possible scores 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.
Outcome measures
| Measure |
Singing group
n=37 Participants
This is a single-arm trial in which all participants are allocated to our online Melodies for Mums singing intervention.
|
|---|---|
|
To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Anxiety, Using the State-Trait Anxiety Scale (STAI)
Week 3
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41.7 score on a scale
Standard Error 26.8
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|
To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Anxiety, Using the State-Trait Anxiety Scale (STAI)
Baseline
|
48.4 score on a scale
Standard Error 27.1
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|
To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Anxiety, Using the State-Trait Anxiety Scale (STAI)
Week 6
|
37.1 score on a scale
Standard Error 26.8
|
|
To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Anxiety, Using the State-Trait Anxiety Scale (STAI)
Week 16
|
37.9 score on a scale
Standard Error 26.7
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|
To Assess Whether Online Singing Improves (Changes) Further Aspects of Mental Health, Including Anxiety, Using the State-Trait Anxiety Scale (STAI)
Week 32
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37.2 score on a scale
Standard Error 25.9
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SECONDARY outcome
Timeframe: Compare changes between baseline and week 6To 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
M4M Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place