Depression, PostpartumNCT02526407
The Impact of Creative Interventions on Symptoms of Postnatal Depression
A study testing Singing and Group play in people with Depression, Postpartum, run by Royal College of Music at 2 sites in United Kingdom.
Trial summary
Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating postnatal… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Singing and Group play
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 Oct 2015to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who have a child up to 9 months old
- Symptoms suggestive of PND at a minimum score of 10 on the EPDS
Who cannot join
- Outside the limits of the number of weeks pregnant/post birth
- Living outside England
- Refusal to participants
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Chelsea and Westminster Hospital
London, SW10 9HS
Centre for Performance Science, Royal College of Music
London, SW7 2BS
About this study
Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating postnatal depression, and flaws in the current pharmacological and psychological treatment models. Consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating postnatal depression.
This project is an ambitious programme of research that investigates the effects of music on postnatal depression through two phases: a questionnaire study and an intervention study. This record is for the intervention study. The questionnaire study has a separate record. We are accepting host hospital sites for both.
Read the detailed description
The study tests the effectiveness of singing interventions led by the Royal College of Music at Chelsea and Westminster Hospital as a psychosocial tool to reduce the occurrence and effects of postnatal depression. It triangulates psychological, physiological, and biological data in a randomised control design to provide a comprehensive insight into the intervention's effects in comparison to a more common psychosocial intervention for new mothers (play groups) and a control group of no psychosocial interventions. The study aims to recruit 50-80 women into each of the three interventions (150-240 total).
The study will used a mixed-method methodology comprising validated psychological scales, in-depth qualitative interviews and observations and biomarker analysis. If results are promising, there are plans in place to scale the singing intervention to more hospitals and community settings.
Phase B will be open to NHS sites within the region of Chelsea and Westminster Hospital London from which women could travel to the sessions to take part.
- Conditions
- Depression, Postpartum
- Being tested
- Singing, Group play
- Keywords
- postnatal depression, mental wellbeing, baby blues, mothers, music, alternative therapies
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SingingBehavioural
Sessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will learn songs with their babies and help to create new musical material together.
Group playBehavioural
Sessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will take part in group play activities.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants continue with usual care. No planned intervention. |
| Group play | Active comparator | Participants take part in 10 weeks of group play activities for one hour per week with their baby in a community setting alongside any usual care they may be receiving. Receives: Behavioral: Group play |
| Singing | Experimental | Participants take part in 10 weeks of group singing activities for one hour per week with their baby in a community setting alongside any usual care they may be receiving. Receives: Behavioral: Singing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postnatal depression
Measured with the Edinburgh Postnatal Depression Scale
Measured: Change from baseline at 6 weeks and 10 weeks
Secondary outcomes (4)
Mental wellbeing
Measured with the short Warwick-Edinburgh Mental Wellbeing Scale
Measured: Change from baseline at 6 weeks and 10 weeks
Self-esteem
Measured with the Rosenberg Self-esteem scale
Measured: Change from baseline at 6 weeks and 10 weeks
Social functioning
Measured with the Social Provisions Scale
Measured: Change from baseline at 6 weeks and 10 weeks
Inflammatory immune response
Measured with saliva samples to test for cortisol and cytokine activity
Measured: Change from baseline at 6 weeks and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start19 Oct 2015
- Primary completion31 Jul 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Music
- Sponsor type
- University, hospital or other
- Collaborators
- Chelsea and Westminster NHS Foundation Trust, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Aaron Williamon, PhD, Study chair, Royal College of Music / Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526407
- Sponsor's protocol ID
- SATB2015
- Status last verified
- Apr 2017
- First submitted
- 14 Aug 2015
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fancourt D, Perkins R. Creative interventions for symptoms of postnatal depression: A process evaluation of implementation. Arts Health. 2019 Feb;11(1):38-53. doi: 10.1080/17533015.2017.1413398. Epub 2018 Jan 23.
PubMed 31038038Perkins R, Yorke S, Fancourt D. How group singing facilitates recovery from the symptoms of postnatal depression: a comparative qualitative study. BMC Psychol. 2018 Aug 17;6(1):41. doi: 10.1186/s40359-018-0253-0.
PubMed 30119704Fancourt 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.
PubMed 29436333
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Creative Interventions on Symptoms of Postnatal Depression
- ClinicalTrials.gov ID
- NCT02526407
- Acronym / sponsor ID
- SATB2015
- Conditions
- Depression, Postpartum
- Keywords
- postnatal depression, mental wellbeing, baby blues, mothers, music, alternative therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Royal College of MusicUniversity, hospital or other
- Collaborators
- Chelsea and Westminster NHS Foundation Trust, Imperial College London
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating postnatal depression, and flaws in the current pharmacological and psychological treatment models. Consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating postnatal depression.
This project is an ambitious programme of research that investigates the effects of music on postnatal depression through two phases: a questionnaire study and an intervention study. This record is for the intervention study. The questionnaire study has a separate record. We are accepting host hospital sites for both.
Detailed description
The study tests the effectiveness of singing interventions led by the Royal College of Music at Chelsea and Westminster Hospital as a psychosocial tool to reduce the occurrence and effects of postnatal depression. It triangulates psychological, physiological, and biological data in a randomised control design to provide a comprehensive insight into the intervention's effects in comparison to a more common psychosocial intervention for new mothers (play groups) and a control group of no psychosocial interventions. The study aims to recruit 50-80 women into each of the three interventions (150-240 total).
The study will used a mixed-method methodology comprising validated psychological scales, in-depth qualitative interviews and observations and biomarker analysis. If results are promising, there are plans in place to scale the singing intervention to more hospitals and community settings.
Phase B will be open to NHS sites within the region of Chelsea and Westminster Hospital London from which women could travel to the sessions to take part.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants continue with usual care. No planned intervention. |
| Group play | Active comparator | Behavioral: Group playParticipants take part in 10 weeks of group play activities for one hour per week with their baby in a community setting alongside any usual care they may be receiving. |
| Singing | Experimental | Behavioral: SingingParticipants take part in 10 weeks of group singing activities for one hour per week with their baby in a community setting alongside any usual care they may be receiving. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who have a child up to 9 months old
- Symptoms suggestive of PND at a minimum score of 10 on the EPDS
Key exclusion criteria (3 listed)
- Outside the limits of the number of weeks pregnant/post birth
- Living outside England
- Refusal to participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SingingSessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will learn songs with their babies and help to create new musical material together. | Behavioural | Singing |
| Group playSessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will take part in group play activities. | Behavioural | Group play |
Primary outcome
Postnatal depression
Time frame: Change from baseline at 6 weeks and 10 weeks
Measured with the Edinburgh Postnatal Depression Scale
4 secondary outcomes
Mental wellbeing
Time frame: Change from baseline at 6 weeks and 10 weeks
Self-esteem
Time frame: Change from baseline at 6 weeks and 10 weeks
Social functioning
Time frame: Change from baseline at 6 weeks and 10 weeks
Inflammatory immune response
Time frame: Change from baseline at 6 weeks and 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Derived from this study: PubMed 31038038Fancourt D, Perkins R. Creative interventions for symptoms of postnatal depression: A process evaluation of implementation. Arts Health. 2019 Feb;11(1):38-53. doi: 10.1080/17533015.2017.1413398. Epub 2018 Jan 23.
- Derived from this study: PubMed 30119704Perkins R, Yorke S, Fancourt D. How group singing facilitates recovery from the symptoms of postnatal depression: a comparative qualitative study. BMC Psychol. 2018 Aug 17;6(1):41. doi: 10.1186/s40359-018-0253-0.
- Derived from this study: PubMed 29436333Fancourt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Williamon, PhD study chair
Royal College of Music / Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing and Group play in people with Depression, Postpartum, run by Royal College of Music at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postnatal depression (time frame: Change from baseline at 6 weeks and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526407, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.