Depression, PostpartumNCT02526433
The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)
An observational study of Depression, Postpartum, run by Royal College of Music at 1 site 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 PND, and… 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
- How many people
- 2,558 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2015to 31 Jan 2017
- Phase
- Observational
- 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
Study population: Women in the final 3 months of pregnancy or the first 9 months post-birth
Who may be able to join
- Women who are more than 28 weeks pregnant OR up to 9 months post-birth
Who cannot join
- Outside the limits of the number of weeks pregnant/post birth
- Living outside England
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
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 PND, 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 PND.
This project is an ambitious programme of research that investigates links between the mental health of women in the later stages of pregnancy and first 9 months post birth and their use of psychosocial interventions including music.
Read the detailed description
The study uses an online questionnaire to achieve a cross-sectional view of the mental health of women across England in the final stages of pregnancy and the first 9 months post birth, how much and in what ways music is used by these women, and whether there are any associations between music and mental health. The study aims to recruit between 1,000 and 5,000 women to take the anonymous questionnaire. However, women who complete the questionnaire while still pregnant will be invited to complete three further questionnaires shortly post-birth and 3 months later to gather longitudinal data to analyse change across pregnancy into post-birth (aiming for 500 of the 1,000 undertaking this repeated measurement).
Phase A of the study will be open to NHS sites around England to take part.
- Conditions
- Depression, Postpartum
- Keywords
- depression, mental wellbeing, motherhood, music, alternative therapies
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy women and new mothers | The study tracks what interventions women are already registered in and compares these with their mental wellbeing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Measured using the Edinburgh Postnatal Depression Scale
Measured: Retrospective measure since the date of completion of the previous questionnaire
Secondary outcomes (4)
Mental wellbeing
Measured using the short Warwick-Edinburgh Mental Wellbeing Scale
Measured: Retrospective measure since the date of completion of the previous questionnaire
Social functioning
Measured using the Social Provisions Scale
Measured: Retrospective measure since the date of completion of the previous questionnaire
Self-esteem
Measured using the Rosenberg Self-esteem Scale
Measured: Retrospective measure since the date of completion of the previous questionnaire
Further questions assessing health and wellbeing including perceived health, health service utilisation, mother-infant bond and creative participation
A range of self-report questions
Measured: Retrospective measure since the date of completion of the previous questionnaire
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 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Music
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT02526433
- Sponsor's protocol ID
- SATB2015b
- Status last verified
- Apr 2017
- First submitted
- 14 Aug 2015
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 (Cohort Study)
- ClinicalTrials.gov ID
- NCT02526433
- Acronym / sponsor ID
- SATB2015b
- Conditions
- Depression, Postpartum
- Keywords
- depression, mental wellbeing, motherhood, music, alternative therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,558 participants (actual)
- Lead sponsor
- Royal College of MusicUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (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 PND, 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 PND.
This project is an ambitious programme of research that investigates links between the mental health of women in the later stages of pregnancy and first 9 months post birth and their use of psychosocial interventions including music.
Detailed description
The study uses an online questionnaire to achieve a cross-sectional view of the mental health of women across England in the final stages of pregnancy and the first 9 months post birth, how much and in what ways music is used by these women, and whether there are any associations between music and mental health. The study aims to recruit between 1,000 and 5,000 women to take the anonymous questionnaire. However, women who complete the questionnaire while still pregnant will be invited to complete three further questionnaires shortly post-birth and 3 months later to gather longitudinal data to analyse change across pregnancy into post-birth (aiming for 500 of the 1,000 undertaking this repeated measurement).
Phase A of the study will be open to NHS sites around England to take part.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy women and new mothers | – | –The study tracks what interventions women are already registered in and compares these with their mental wellbeing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women in the final 3 months of pregnancy or the first 9 months post-birth
Key inclusion criteria (1 listed)
- Women who are more than 28 weeks pregnant OR up to 9 months post-birth
Key exclusion criteria (3 listed)
- Outside the limits of the number of weeks pregnant/post birth
- Living outside England
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression
Time frame: Retrospective measure since the date of completion of the previous questionnaire
Measured using the Edinburgh Postnatal Depression Scale
4 secondary outcomes
Mental wellbeing
Time frame: Retrospective measure since the date of completion of the previous questionnaire
Social functioning
Time frame: Retrospective measure since the date of completion of the previous questionnaire
Self-esteem
Time frame: Retrospective measure since the date of completion of the previous questionnaire
Further questions assessing health and wellbeing including perceived health, health service utilisation, mother-infant bond and creative participation
Time frame: Retrospective measure since the date of completion of the previous questionnaire
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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Postpartum, run by Royal College of Music at 1 site 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 1 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 1 site 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?
Depression (time frame: Retrospective measure since the date of completion of the previous questionnaire). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.