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

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

Study Description

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 Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Royal College of Music
• ClinicalTrials.gov Identifier: NCT02526433
• Other Study ID Numbers: SATB2015b
• First Posted: August 18, 2015
• 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, Postpartum; Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases