The Impact of Creative Interventions on Symptoms of Postnatal Depression

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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

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

  • United Kingdom
      • London, United Kingdom, SW10 9HS
        • Chelsea And Westminster Hospital
      • 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

Description

Inclusion Criteria:

  • Women who have a child up to 9 months old
  • Symptoms suggestive of PND at a minimum score of 10 on the EPDS

Exclusion Criteria:

  • Outside the limits of the number of weeks pregnant/post birth
  • Living outside England
  • Refusal to participants

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants continue with usual care. No planned intervention.
Active Comparator: Group play
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.
Behavioral: Group play
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.
Experimental: Singing
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.
Behavioral: Singing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postnatal depression
Time Frame: Change from baseline at 6 weeks and 10 weeks
Measured with the Edinburgh Postnatal Depression Scale
Change from baseline at 6 weeks and 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental wellbeing
Time Frame: Change from baseline at 6 weeks and 10 weeks
Measured with the short Warwick-Edinburgh Mental Wellbeing Scale
Change from baseline at 6 weeks and 10 weeks
Self-esteem
Time Frame: Change from baseline at 6 weeks and 10 weeks
Measured with the Rosenberg Self-esteem scale
Change from baseline at 6 weeks and 10 weeks
Social functioning
Time Frame: Change from baseline at 6 weeks and 10 weeks
Measured with the Social Provisions Scale
Change from baseline at 6 weeks and 10 weeks
Inflammatory immune response
Time Frame: Change from baseline at 6 weeks and 10 weeks
Measured with saliva samples to test for cortisol and cytokine activity
Change from baseline at 6 weeks and 10 weeks

Collaborators and Investigators

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

Sponsor

Royal College of Music

Collaborators

Imperial College London
Chelsea and Westminster NHS Foundation Trust

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 31, 2016

Study Completion (Actual)

September 30, 2016

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

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SATB2015

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.

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