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

April 12, 2017 updated by: Royal College of Music

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

2558

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, SW7 2BS
        • Centre for Performance Science, Royal College of Music

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women in the final 3 months of pregnancy or the first 9 months post-birth

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pregnancy women and new mothers
The study tracks what interventions women are already registered in and compares these with their mental wellbeing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Retrospective measure since the date of completion of the previous questionnaire
Measured using the Edinburgh Postnatal Depression Scale
Retrospective measure since the date of completion of the previous questionnaire

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental wellbeing
Time Frame: Retrospective measure since the date of completion of the previous questionnaire
Measured using the short Warwick-Edinburgh Mental Wellbeing Scale
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
Measured using the Social Provisions Scale
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
Measured using the Rosenberg Self-esteem Scale
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
A range of self-report questions
Retrospective measure since the date of completion of the previous questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Aaron Williamon, PhD, Royal College of Music / Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2015

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression, Postpartum

3
Subscribe