Clinical trial NCT02526433: The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)
Official title: The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression, Postpartum
Keywords: depression
mental wellbeing
motherhood
music
alternative therapies
Lead sponsor: Royal College of Music
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2015-08-18
Enrollment: 2558
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in the final 3 months of pregnancy or the first 9 months post-birth

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Women who are more than 28 weeks pregnant OR up to 9 months post-birth

Exclusion Criteria:

* Outside the limits of the number of weeks pregnant/post birth
* Living outside England
* Refusal to participate

Primary outcomes:
measure: Depression
timeFrame: Retrospective measure since the date of completion of the previous questionnaire
Secondary outcomes:
measure: Mental wellbeing
timeFrame: Retrospective measure since the date of completion of the previous questionnaire
measure: Social functioning
timeFrame: Retrospective measure since the date of completion of the previous questionnaire
measure: Self-esteem
timeFrame: Retrospective measure since the date of completion of the previous questionnaire
measure: Further questions assessing health and wellbeing including perceived health, health service utilisation, mother-infant bond and creative participation
timeFrame: Retrospective measure since the date of completion of the previous questionnaire
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Performance Science, Royal College of Music
Study officials:
affiliation: Royal College of Music / Imperial College London
name: Aaron Williamon, PhD
role: STUDY_CHAIR
References: