mHealth for Antenatal Mental Health

Completed

• Conditions: Pregnancy; Depression
• Interventions: Other: Whooley Questions; Other: Edinburgh Postnatal Depression Scale; Other: Momentary questions; Other: Contextual questions

• Registration Number: NCT02516982
• Lead Sponsor: Imperial College London

Brief Summary

The aim of this study is to determine the feasibility of using mobile technology for:

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.

Detailed Description

As part of our first aim, we will assess the psychometric properties of the Whooley questions, by comparing the answers given to these questions against the scores obtained on the Edinburgh Postnatal Depression Scale, and we will manipulate the survey questionnaire layout of the Whooley Questions and the Edinburgh Postnatal Depression Scale in order to ensure that this survey design choice does not affect data quality. As part of our second aim, we will compare two prospective sampling protocols on patient compliance and engagement with the app.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-06
• Study Start: 2015-10
• Primary Completion: 2018-02
• Study Completion: 2018-08
• Results First Submitted: 2019-05-13
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-20
• Last Update Submitted: 2019-09-20
• Results First Posted: 2019-09-23
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 946

Inclusion Criteria

• Pregnant women attending antenatal clinics

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Exclusion Criteria

• Diagnosis of any common mental health disorder (i.e., depression or anxiety disorders) as specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening - Scrolling layout	Whooley Questions	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.
Screening - Scrolling layout	Edinburgh Postnatal Depression Scale	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.
Screening - Paging layout	Whooley Questions	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.
Retrospective plus momentary assessment	Edinburgh Postnatal Depression Scale	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.
Retrospective plus momentary assessment	Contextual questions	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.
Retrospective assessment	Edinburgh Postnatal Depression Scale	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.
Screening - Paging layout	Edinburgh Postnatal Depression Scale	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.
Retrospective plus momentary assessment	Momentary questions	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.

Primary Outcome Measures

Name	Time	Method
Adherence With a 6-month Follow-up Protocol	6 months	This outcome was measured on the retrospective plus momentary assessment and retrospective assessment groups only. Participants who completed at least one expected assessment during each sampling period
Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout	One-off assessment immediately after recruitment	Number of participants scoring 1 point or more on question 10 of the Edinburgh Postnatal Depression Scale, which deals with thoughts of self-harm. This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups.
Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout	One-off assessment immediately after recruitment	Comparison of the number of participants answering affirmatively to at least one Whooley question in each experimental group. This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups.
Median EPDS Scores According to Survey Layout	One-off assessment immediately after recruitment	This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups. Median scores on the Edinburgh Postnatal Depression Scale according to group allocation. The EPDS consists of 10 questions each rated on a 4-point scale ranging from 0 to 3 points. Overall scores are obtained by adding the scores of all the individual questions, and range from 0 points to 30 points. Overall scores of 0 to 9 points suggest a low risk of perinatal depression. Overall scores between 10 and 12 points suggest an increased risk of perinatal depression. Overall scores of 13 points or more suggest that the respondent is likely to have met the diagnostic criteria for perinatal depression. Moreover, scores of 1 point or more on question 10 of the EPDS ought to be explored further as this question deals with ideas of self-harm.
Number of Participants at Each EPDS Scoring Interval According to Survey Layout	One-off assessment immediately after recruitment	Number of participants scoring at each of the scoring intervals that have been reported for the Edinburgh Postnatal Depression Scale: 0 to 9 points - low risk; 10 to 12 points - moderate risk; 13 points or more - high risk. This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups.

Secondary Outcome Measures

Name	Time	Method
Number of Requests for Technical Assistance by Type of Request and According to Survey Layout	One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent	This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups. Total number of requests for technical assistance made in each experimental group according to type of request.
Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout	One-off assessment immediately after recruitment	This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups. Time elapsed (in seconds) between the participants starting to read the basic instructions on how to complete the survey questionnaires and the participant completing the EPDS. These actions will be indicated by participants pressing the Start button on the device screen and when a message acknowledging that they have completed the survey questionnaires is displayed on the device screen. This component will be broken down further into the individual survey questionnaires that participants will be required to complete (i.e., personal demographic information, Whooley questions, and EPDS). In addition, we will account for the time that participants spend experiencing problems, distractions or making requests for help or clarification.
Proportion of Participants Requesting Technical Assistance According to Survey Layout	One-off assessment immediately after recruitment	This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups. Number of participants who made no requests for technical assistance, and those who requested technical assistance

Trial Locations

Locations (14)

Burton Hospitals; 🇬🇧 Burton, United Kingdom

The Pennine Acute Hospitals; 🇬🇧 Crumpsall, United Kingdom

Hinchinbrooke Hospital; 🇬🇧 Huntingdon, 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

University Hospitals of North Midlands; 🇬🇧 Stoke-on-Trent, United Kingdom

Wrightington, Wigan and Leigh NHS; 🇬🇧 Wigan, United Kingdom

Royal Bolton Hospital; 🇬🇧 Bolton, United Kingdom

Shrewsburty & Telford Hospital; 🇬🇧 Shrewsbury, United Kingdom

East Lancashire; 🇬🇧 Blackburn, United Kingdom

East Midlands CRN; 🇬🇧 Lincoln, United Kingdom