Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact of Creative Interventions on Symptoms of Postnatal Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 14, 2015
First Posted Date  ICMJE August 18, 2015
Last Update Posted Date April 13, 2017
Actual Study Start Date  ICMJE October 19, 2015
Actual Primary Completion Date July 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
Postnatal depression [ Time Frame: Change from baseline at 6 weeks and 10 weeks ]
Measured with the Edinburgh Postnatal Depression Scale
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
Postnatal depression [ Time Frame: Change from baseline at 6 weeks, 10 weeks and 3 month follow-up ]
Measured with the Edinburgh Postnatal Depression Scale
Change History Complete list of historical versions of study NCT02526407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
  • 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 Measures  ICMJE
 (submitted: August 14, 2015)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of Creative Interventions on Symptoms of Postnatal Depression
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Depression, Postpartum
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Group play
  • 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.
    Intervention: Behavioral: Singing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2017)
153
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2015)
240
Actual Study Completion Date  ICMJE September 30, 2016
Actual Primary Completion Date July 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02526407
Other Study ID Numbers  ICMJE SATB2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royal College of Music
Study Sponsor  ICMJE Royal College of Music
Collaborators  ICMJE
  • Chelsea and Westminster NHS Foundation Trust
  • Imperial College London
Investigators  ICMJE
Study Chair: Aaron Williamon, PhD Royal College of Music / Imperial College London
PRS Account Royal College of Music
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP