NCT02526433

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,558

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

August 14, 2015

Last Update Submit

April 12, 2017

Conditions

Keywords

depressionmental wellbeingmotherhoodmusicalternative therapies

Outcome Measures

Primary Outcomes (1)

  • Depression

    Measured using the Edinburgh Postnatal Depression Scale

    Retrospective measure since the date of completion of the previous questionnaire

Secondary Outcomes (4)

  • Mental wellbeing

    Retrospective measure since the date of completion of the previous questionnaire

  • Social functioning

    Retrospective measure since the date of completion of the previous questionnaire

  • Self-esteem

    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

    Retrospective measure since the date of completion of the previous questionnaire

Study Arms (1)

Pregnancy women and new mothers

The study tracks what interventions women are already registered in and compares these with their mental wellbeing.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Performance Science, Royal College of Music

London, SW7 2BS, United Kingdom

Location

MeSH Terms

Conditions

Depression, PostpartumDepression

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Aaron Williamon, PhD

    Royal College of Music / Imperial College London

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
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

January 31, 2017

Study Completion

January 31, 2017

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations