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The Impact of Creative Interventions on Symptoms of Postnatal Depression

R

Royal College of Music

Status

Completed

Conditions

Depression, Postpartum

Treatments

Behavioral: Singing
Behavioral: Group play

Study type

Interventional

Funder types

Other

Identifiers

NCT02526407
SATB2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

153 participants in 3 patient groups

Control
No Intervention group
Description:
Participants continue with usual care. No planned intervention.
Group play
Active Comparator group
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.
Treatment:
Behavioral: Group play
Singing
Experimental group
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.
Treatment:
Behavioral: Singing

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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