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The Impact of Creative Interventions on Symptoms of Postnatal Depression

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ClinicalTrials.gov Identifier: NCT02526407
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : April 13, 2017
Sponsor:
Collaborators:
Chelsea and Westminster NHS Foundation Trust
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 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.


Condition or disease Intervention/treatment Phase
Depression, Postpartum Behavioral: Singing Behavioral: Group play Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of Creative Interventions on Symptoms of Postnatal Depression
Actual Study Start Date : October 19, 2015
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Participants continue with usual care. No planned intervention.
Active Comparator: Group play
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.
Behavioral: Group play
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.

Experimental: Singing
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.
Behavioral: Singing
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.




Primary Outcome Measures :
  1. Postnatal depression [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]
    Measured with the Edinburgh Postnatal Depression Scale


Secondary Outcome Measures :
  1. Mental wellbeing [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]
    Measured with the short Warwick-Edinburgh Mental Wellbeing Scale

  2. Self-esteem [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]
    Measured with the Rosenberg Self-esteem scale

  3. Social functioning [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]
    Measured with the Social Provisions Scale

  4. Inflammatory immune response [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]
    Measured with saliva samples to test for cortisol and cytokine activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT02526407


Locations
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United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9HS
Centre for Performance Science, Royal College of Music
London, United Kingdom, SW7 2BS
Sponsors and Collaborators
Royal College of Music
Chelsea and Westminster NHS Foundation Trust
Imperial College London
Investigators
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Study Chair: Aaron Williamon, PhD Royal College of Music / Imperial College London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal College of Music
ClinicalTrials.gov Identifier: NCT02526407     History of Changes
Other Study ID Numbers: SATB2015
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:
postnatal depression
mental wellbeing
baby blues
mothers
music
alternative therapies
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications