NCT02526407

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 19, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

August 14, 2015

Last Update Submit

April 12, 2017

Conditions

Depression, Postpartum

Keywords

postnatal depressionmental wellbeingbaby bluesmothersmusicalternative therapies

Outcome Measures

Primary Outcomes (1)

  • Postnatal depression

    Measured with the Edinburgh Postnatal Depression Scale

    Change from baseline at 6 weeks and 10 weeks

Secondary Outcomes (4)

  • Mental wellbeing

    Change from baseline at 6 weeks and 10 weeks

  • Self-esteem

    Change from baseline at 6 weeks and 10 weeks

  • Social functioning

    Change from baseline at 6 weeks and 10 weeks

  • Inflammatory immune response

    Change from baseline at 6 weeks and 10 weeks

Study Arms (3)

Control

NO INTERVENTION

Participants continue with usual care. No planned intervention.

Group play

ACTIVE COMPARATOR

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

Singing

EXPERIMENTAL

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

Interventions

SingingBEHAVIORAL

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.

Singing
Group playBEHAVIORAL

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.

Group play

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chelsea and Westminster Hospital

London, SW10 9HS, United Kingdom

Location

Centre for Performance Science, Royal College of Music

London, SW7 2BS, United Kingdom

Location

Related Publications (3)

  • Fancourt D, Perkins R. Creative interventions for symptoms of postnatal depression: A process evaluation of implementation. Arts Health. 2019 Feb;11(1):38-53. doi: 10.1080/17533015.2017.1413398. Epub 2018 Jan 23.

    PMID: 31038038DERIVED

  • Perkins R, Yorke S, Fancourt D. How group singing facilitates recovery from the symptoms of postnatal depression: a comparative qualitative study. BMC Psychol. 2018 Aug 17;6(1):41. doi: 10.1186/s40359-018-0253-0.

    PMID: 30119704DERIVED

  • Fancourt D, Perkins R. Effect of singing interventions on symptoms of postnatal depression: three-arm randomised controlled trial. Br J Psychiatry. 2018 Feb;212(2):119-121. doi: 10.1192/bjp.2017.29.

    PMID: 29436333DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Singing

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhonationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Aaron Williamon, PhD

    Royal College of Music / Imperial College London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 18, 2015

Study Start

October 19, 2015

Primary Completion

July 31, 2016

Study Completion

September 30, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

GB(2)