The Impact of Creative Interventions on Symptoms of Postnatal Depression

NCT ID: NCT02526407

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-19

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Depression, Postpartum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Participants continue with usual care. No planned intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Group play

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Singing

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

Royal College of Music

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Williamon, PhD

Role: STUDY_CHAIR

Royal College of Music / Imperial College London

Locations

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Chelsea and Westminster Hospital

London, , United Kingdom

Site Status

Centre for Performance Science, Royal College of Music

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31038038 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30119704 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29436333 (View on PubMed)

Other Identifiers

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SATB2015

Identifier Type: -

Identifier Source: org_study_id

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