Study Results
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View full resultsBasic Information
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COMPLETED
946 participants
OBSERVATIONAL
2015-10-31
2018-08-31
Brief Summary
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1. Implementing the recommendations of the Antenatal and postnatal mental health: clinical management and service guidance NICE guideline for recognising depression (i.e., Whooley questions followed by a validated screening instrument such as the Edinburgh Postnatal Depression Scale) during pregnancy using iPad Air tablets in the waiting area of general practices, midwifery services, or hospitals during antenatal clinics; and
2. Using a bespoke app running on pregnant women's own smartphones to monitor mood and symptoms of depression throughout pregnancy.
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Detailed Description
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We will use a parallel, randomised control trial study design. Participation in each part of the study (i.e., iPads in antenatal clinics, or app running on own handset) will be independent from each other. Those participants consenting to get involved in the part of the study assessing the use of iPads in antenatal clinics will be randomly assigned to complete (i) an app version of the Whooley questions and the Edinburgh Postnatal Depression Scale in which the questionnaires are presented using a scrolling layout (i.e., App screening - Scrolling), or (ii) an app version of the Whooley questions and the Edinburgh Postnatal Depression Scale in which the questionnaires are presented using a paging layout (i.e., App screening - Paging).
Participants consenting to get involved in the part of the study assessing the use of an app running on participants' own devices will be randomly allocated to one of two sampling protocols: (i) a prospective sampling protocol of 6 months consisting of the Edinburgh Postnatal Depression Scale and 5 momentary questions related to mood; or (ii) a prospective sampling protocol of 6 months consisting of the Edinburgh Postnatal Depression Scale.
We will utilise a block randomisation procedure (with blocks of 4) to generate our allocation sequence. Random numbers will be generated using Stata 13.0. Researchers conducting participant recruitment will not be involved in this randomisation procedure in order to avoid recruitment bias.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Screening - Scrolling layout
Participants will be asked to complete a survey consisting of three sections using an iPad Air tablet:
* Section 1: Demographic information survey
* Section 2: Whooley questions
* Section 3: Edinburgh Postnatal Depression Scale
All questions will be presented on a single screen. This means that participants will have to scroll vertically in order to answer all the questions.
Whooley Questions
The Whooley questions are a case-finding instrument for depression in primary care. This 2-question instrument screens for depressed mood and anhedonia that have been present during the past month. Respondents are required to answer Yes or No to each of these questions. An affirmative answer to any of them should be followed by further assessment, including the use of a validated screening instrument or referral to a general practitioner or a mental health practitioner.
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
Screening - Paging layout
Participants will be asked to complete a survey consisting of three sections using an iPad Air tablet:
* Section 1: Demographic information survey
* Section 2: Whooley questions
* Section 3: Edinburgh Postnatal Depression Scale
Only one question will be presented at any given time. This means that participants will have to navigate through multiple pages in order to answer all the questions.
Whooley Questions
The Whooley questions are a case-finding instrument for depression in primary care. This 2-question instrument screens for depressed mood and anhedonia that have been present during the past month. Respondents are required to answer Yes or No to each of these questions. An affirmative answer to any of them should be followed by further assessment, including the use of a validated screening instrument or referral to a general practitioner or a mental health practitioner.
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
Retrospective plus momentary assessment
Participants in this group will be asked to download and install an app onto their own smartphones. After that, they will be asked to complete a sampling protocol consisting of 6 consecutive days, once a month for 6 months. During the 6 assessment days, participants will be required to complete the Edinburgh Postnatal Depression Scale, 5 momentary questions on a 5-point pictorial scale, and 2 contextual questions.
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
Momentary questions
These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry.
Contextual questions
Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions.
Retrospective assessment
Participants in this group will be asked to download and install an app onto their own smartphones. After that, they will be asked to complete a sampling protocol consisting of one day a month for 6 months. The assessment days will consist of a single administration of the Edinburgh Postnatal Depression Scale.
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
Interventions
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Whooley Questions
The Whooley questions are a case-finding instrument for depression in primary care. This 2-question instrument screens for depressed mood and anhedonia that have been present during the past month. Respondents are required to answer Yes or No to each of these questions. An affirmative answer to any of them should be followed by further assessment, including the use of a validated screening instrument or referral to a general practitioner or a mental health practitioner.
Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
Momentary questions
These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry.
Contextual questions
Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Receiving treatment for any common mental health disorder
* Recent personal history of any common mental health disorder (i.e., within the past 12 months)
* Not comfortable reading and writing in English
Participants enrolled in the study assessing an app for the monitoring of mood and symptoms of depression need to own an iPhone or any Android-compatible smartphone.
18 Years
FEMALE
Yes
Sponsors
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Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Jose S Marcano Belisario
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Josip Car
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Cecily Morrison
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
John O'Donoghue
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Ajay Gupta
Role: STUDY_CHAIR
Imperial College London
Paul Ramchandani
Role: STUDY_CHAIR
Imperial College London
Gavin Doherty
Role: PRINCIPAL_INVESTIGATOR
University of Dublin, Trinity College
Kevin Doherty
Role: PRINCIPAL_INVESTIGATOR
University of Dublin, Trinity College
Locations
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East Lancashire
Blackburn, , United Kingdom
Royal Bolton Hospital
Bolton, , United Kingdom
Burton Hospitals
Burton, , United Kingdom
The Pennine Acute Hospitals
Crumpsall, , United Kingdom
Hinchinbrooke Hospital
Huntingdon, , United Kingdom
East Midlands CRN
Lincoln, , United Kingdom
Chelsea & Westminster Hospital
London, , United Kingdom
Hillingdon Hospitals
London, , United Kingdom
Northwick Park Hospital
London, , United Kingdom
West Middlesex Hospital
London, , United Kingdom
North of England
Newcastle, , United Kingdom
Shrewsburty & Telford Hospital
Shrewsbury, , United Kingdom
University Hospitals of North Midlands
Stoke-on-Trent, , United Kingdom
Wrightington, Wigan and Leigh NHS
Wigan, , United Kingdom
Countries
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References
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Marcano-Belisario JS, Gupta AK, O'Donoghue J, Morrison C, Car J. Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility study. BMJ Open. 2016 Jan 22;6(1):e009930. doi: 10.1136/bmjopen-2015-009930.
Marcano Belisario JS, Doherty K, O'Donoghue J, Ramchandani P, Majeed A, Doherty G, Morrison C, Car J. A bespoke mobile application for the longitudinal assessment of depression and mood during pregnancy: protocol of a feasibility study. BMJ Open. 2017 May 29;7(5):e014469. doi: 10.1136/bmjopen-2016-014469.
Marcano-Belisario JS, Gupta AK, O'Donoghue J, Ramchandani P, Morrison C, Car J. Implementation of depression screening in antenatal clinics through tablet computers: results of a feasibility study. BMC Med Inform Decis Mak. 2017 May 10;17(1):59. doi: 10.1186/s12911-017-0459-8.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15IC2687
Identifier Type: -
Identifier Source: org_study_id
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