Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-25 @ 11:07 PM
Study NCT ID:
NCT02526433
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2015-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2558}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-12', 'studyFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2015-08-14', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Retrospective measure since the date of completion of the previous questionnaire', 'description': 'Measured using the Edinburgh Postnatal Depression Scale'}], 'secondaryOutcomes': [{'measure': 'Mental wellbeing', 'timeFrame': 'Retrospective measure since the date of completion of the previous questionnaire', 'description': 'Measured using the short Warwick-Edinburgh Mental Wellbeing Scale'}, {'measure': 'Social functioning', 'timeFrame': 'Retrospective measure since the date of completion of the previous questionnaire', 'description': 'Measured using the Social Provisions Scale'}, {'measure': 'Self-esteem', 'timeFrame': 'Retrospective measure since the date of completion of the previous questionnaire', 'description': 'Measured using the Rosenberg Self-esteem Scale'}, {'measure': 'Further questions assessing health and wellbeing including perceived health, health service utilisation, mother-infant bond and creative participation', 'timeFrame': 'Retrospective measure since the date of completion of the previous questionnaire', 'description': 'A range of self-report questions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['depression', 'mental wellbeing', 'motherhood', 'music', 'alternative therapies'], 'conditions': ['Depression, Postpartum']}, 'descriptionModule': {'briefSummary': '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 PND, 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 PND.\n\nThis project is an ambitious programme of research that investigates links between the mental health of women in the later stages of pregnancy and first 9 months post birth and their use of psychosocial interventions including music.', 'detailedDescription': 'The study uses an online questionnaire to achieve a cross-sectional view of the mental health of women across England in the final stages of pregnancy and the first 9 months post birth, how much and in what ways music is used by these women, and whether there are any associations between music and mental health. The study aims to recruit between 1,000 and 5,000 women to take the anonymous questionnaire. However, women who complete the questionnaire while still pregnant will be invited to complete three further questionnaires shortly post-birth and 3 months later to gather longitudinal data to analyse change across pregnancy into post-birth (aiming for 500 of the 1,000 undertaking this repeated measurement).\n\nPhase A of the study will be open to NHS sites around England to take part.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women in the final 3 months of pregnancy or the first 9 months post-birth', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who are more than 28 weeks pregnant OR up to 9 months post-birth\n\nExclusion Criteria:\n\n* Outside the limits of the number of weeks pregnant/post birth\n* Living outside England\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT02526433', 'briefTitle': 'The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Music'}, 'officialTitle': 'The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)', 'orgStudyIdInfo': {'id': 'SATB2015b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnancy women and new mothers', 'description': 'The study tracks what interventions women are already registered in and compares these with their mental wellbeing.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW7 2BS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Centre for Performance Science, Royal College of Music', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Aaron Williamon, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Royal College of Music / Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Music', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}