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

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ClinicalTrials.gov Identifier: NCT02526433
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Royal College of Music

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.


Condition or disease
Depression, Postpartum

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
Actual Enrollment : 2558 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)
Actual Study Start Date : October 19, 2015
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Depression [ Time Frame: Retrospective measure since the date of completion of the previous questionnaire ]
    Measured using the Edinburgh Postnatal Depression Scale


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women in the final 3 months of pregnancy or the first 9 months post-birth
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526433


Locations
United Kingdom
Centre for Performance Science, Royal College of Music
London, United Kingdom, SW7 2BS
Sponsors and Collaborators
Royal College of Music
Imperial College London
Investigators
Study Chair: Aaron Williamon, PhD Royal College of Music / Imperial College London

Responsible Party: Royal College of Music
ClinicalTrials.gov Identifier: NCT02526433     History of Changes
Other Study ID Numbers: SATB2015b
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Keywords provided by Royal College of Music:
depression
mental wellbeing
motherhood
music
alternative therapies

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications