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Completed

NCT Number: NCT02526433

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

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.

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Key information

Conditions

Depression, Postpartum Behavior Behavioral Symptoms Depression Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre for Performance Science, Royal College of Music

London, SW7 2BS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Depression

    Time frame: Retrospective measure since the date of completion of the previous questionnaire

    Measured using the Edinburgh Postnatal Depression Scale

Secondary outcomes

  1. Mental wellbeing

    Time frame: Retrospective measure since the date of completion of the previous questionnaire

    Measured using the short Warwick-Edinburgh Mental Wellbeing Scale

  2. Social functioning

    Time frame: Retrospective measure since the date of completion of the previous questionnaire

    Measured using the Social Provisions Scale

  3. Self-esteem

    Time frame: Retrospective measure since the date of completion of the previous questionnaire

    Measured using the Rosenberg Self-esteem Scale

  4. 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

Sponsors and collaborators

Lead sponsor

Royal College of Music

Other

Collaborators

  • Imperial College London

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2015
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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