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The Impact of Creative Interventions on Symptoms of Postnatal Depression

Primary Purpose

Depression, Postpartum

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Singing
Group play
Sponsored by
Royal College of Music
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression, Postpartum focused on measuring postnatal depression, mental wellbeing, baby blues, mothers, music, alternative therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Chelsea and Westminster Hospital
  • Centre for Performance Science, Royal College of Music

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control

Group play

Singing

Arm Description

Participants continue with usual care. No planned intervention.

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.

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.

Outcomes

Primary Outcome Measures

Postnatal depression
Measured with the Edinburgh Postnatal Depression Scale

Secondary Outcome Measures

Mental wellbeing
Measured with the short Warwick-Edinburgh Mental Wellbeing Scale
Self-esteem
Measured with the Rosenberg Self-esteem scale
Social functioning
Measured with the Social Provisions Scale
Inflammatory immune response
Measured with saliva samples to test for cortisol and cytokine activity

Full Information

First Posted
August 14, 2015
Last Updated
April 12, 2017
Sponsor
Royal College of Music
Collaborators
Chelsea and Westminster NHS Foundation Trust, Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT02526407
Brief Title
The Impact of Creative Interventions on Symptoms of Postnatal Depression
Official Title
The Impact of Creative Interventions on Symptoms of Postnatal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 19, 2015 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal College of Music
Collaborators
Chelsea and Westminster NHS Foundation Trust, Imperial College London

4. Oversight

Data Monitoring Committee
No

5. 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 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.
Detailed Description
The study tests the effectiveness of singing interventions led by the Royal College of Music at Chelsea and Westminster Hospital as a psychosocial tool to reduce the occurrence and effects of postnatal depression. It triangulates psychological, physiological, and biological data in a randomised control design to provide a comprehensive insight into the intervention's effects in comparison to a more common psychosocial intervention for new mothers (play groups) and a control group of no psychosocial interventions. The study aims to recruit 50-80 women into each of the three interventions (150-240 total). The study will used a mixed-method methodology comprising validated psychological scales, in-depth qualitative interviews and observations and biomarker analysis. If results are promising, there are plans in place to scale the singing intervention to more hospitals and community settings. Phase B will be open to NHS sites within the region of Chelsea and Westminster Hospital London from which women could travel to the sessions to take part.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum
Keywords
postnatal depression, mental wellbeing, baby blues, mothers, music, alternative therapies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants continue with usual care. No planned intervention.
Arm Title
Group play
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Singing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Singing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group play
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postnatal depression
Description
Measured with the Edinburgh Postnatal Depression Scale
Time Frame
Change from baseline at 6 weeks and 10 weeks
Secondary Outcome Measure Information:
Title
Mental wellbeing
Description
Measured with the short Warwick-Edinburgh Mental Wellbeing Scale
Time Frame
Change from baseline at 6 weeks and 10 weeks
Title
Self-esteem
Description
Measured with the Rosenberg Self-esteem scale
Time Frame
Change from baseline at 6 weeks and 10 weeks
Title
Social functioning
Description
Measured with the Social Provisions Scale
Time Frame
Change from baseline at 6 weeks and 10 weeks
Title
Inflammatory immune response
Description
Measured with saliva samples to test for cortisol and cytokine activity
Time Frame
Change from baseline at 6 weeks and 10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women who have a child up to 9 months old Symptoms suggestive of PND at a minimum score of 10 on the EPDS Exclusion Criteria: Outside the limits of the number of weeks pregnant/post birth Living outside England Refusal to participants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Williamon, PhD
Organizational Affiliation
Royal College of Music / Imperial College London
Official's Role
Study Chair
Facility Information:
Facility Name
Chelsea and Westminster Hospital
City
London
ZIP/Postal Code
SW10 9HS
Country
United Kingdom
Facility Name
Centre for Performance Science, Royal College of Music
City
London
ZIP/Postal Code
SW7 2BS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31038038
Citation
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.
Results Reference
derived
PubMed Identifier
30119704
Citation
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.
Results Reference
derived
PubMed Identifier
29436333
Citation
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.
Results Reference
derived

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The Impact of Creative Interventions on Symptoms of Postnatal Depression

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