The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)

Depression, Postpartum Clinical Trial

Official title:

The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526433
• Other study ID #: SATB2015b
• Status: Completed
• Phase: N/A
• First received: August 14, 2015
• Last updated: April 12, 2017
• Start date: October 19, 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: April 2017
• Source: Royal College of Music
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2558
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Locations

Country	Name	City	State
United Kingdom	Centre for Performance Science, Royal College of Music	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal College of Music	Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Measured using the Edinburgh Postnatal Depression Scale	Retrospective measure since the date of completion of the previous questionnaire
Secondary	Mental wellbeing	Measured using the short Warwick-Edinburgh Mental Wellbeing Scale	Retrospective measure since the date of completion of the previous questionnaire
Secondary	Social functioning	Measured using the Social Provisions Scale	Retrospective measure since the date of completion of the previous questionnaire
Secondary	Self-esteem	Measured using the Rosenberg Self-esteem Scale	Retrospective measure since the date of completion of the previous questionnaire
Secondary	Further questions assessing health and wellbeing including perceived health, health service utilisation, mother-infant bond and creative participation	A range of self-report questions	Retrospective measure since the date of completion of the previous questionnaire