Clinical Trial: The Impact of Creative Interventions on Symptoms of Postnatal Depression

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Impact of Creative Interventions on Symptoms of Postnatal Depression

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 Summary:

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.


Sponsor: Royal College of Music

Current Primary Outcome: Postnatal depression [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]

Measured with the Edinburgh Postnatal Depression Scale


Original Primary Outcome: Postnatal depression [ Time Frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up ]

Measured with the Edinburgh Postnatal Depression Scale


Current Secondary Outcome:

  • Mental wellbeing [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]
    Measured with the short Warwick-Edinburgh Mental Wellbeing Scale
  • Self-esteem [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]
    Measured with the Rosenberg Self-esteem scale
  • Social functioning [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]
    Measured with the Social Provisions Scale
  • 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


Original Secondary Outcome:

  • Self-esteem [ Time Frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up ]
    Measured with the Rosenberg Self-esteem scale
  • Social functioning [ Time Frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up ]
    Measured with the Social Provisions Scale
  • Mental wellbeing [ Time Frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up ]
    Measured with the Warwick-Edinburgh Mental Wellbeing Scale
  • Inflammatory immune response [ Time Frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up ]
    Measured with saliva samples to test for cortisol and cytokine activity


Information By: Royal College of Music

Dates:
Date Received: August 14, 2015
Date Started: October 19, 2015
Date Completion:
Last Updated: April 12, 2017
Last Verified: April 2017