Clinical trial NCT02516982: mHealth for Antenatal Mental Health
Official title: Tablet Computers for Implementing NICE Antenatal Mental Health Guidelines - Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Pregnancy
Keywords: mHealth
Telemedicine
Perinatal depression
Screening
Edinburgh Postnatal Depression Scale
Whooley Questions
Data collection
Mood disorders
Mental health
Antenatal care
Prenatal Care
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 946
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who are 18 years old or older.

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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women attending antenatal clinics

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.

Primary outcomes:
measure: Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout
timeFrame: One-off assessment immediately after recruitment
measure: Median EPDS Scores According to Survey Layout
timeFrame: One-off assessment immediately after recruitment
measure: Number of Participants at Each EPDS Scoring Interval According to Survey Layout
timeFrame: One-off assessment immediately after recruitment
measure: Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout
timeFrame: One-off assessment immediately after recruitment
measure: Adherence With a 6-month Follow-up Protocol
timeFrame: 6 months
Secondary outcomes:
measure: Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout
timeFrame: One-off assessment immediately after recruitment
measure: Proportion of Participants Requesting Technical Assistance According to Survey Layout
timeFrame: One-off assessment immediately after recruitment
measure: Number of Requests for Technical Assistance by Type of Request and According to Survey Layout
timeFrame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent
Other outcomes:
Locations:
city: Blackburn
country: United Kingdom
facility: East Lancashire
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Burton
country: United Kingdom
facility: Burton Hospitals
city: Crumpsall
country: United Kingdom
facility: The Pennine Acute Hospitals
city: Huntingdon
country: United Kingdom
facility: Hinchinbrooke Hospital
city: Lincoln
country: United Kingdom
facility: East Midlands CRN
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
city: London
country: United Kingdom
facility: Hillingdon Hospitals
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: London
country: United Kingdom
facility: West Middlesex Hospital
city: Newcastle
country: United Kingdom
facility: North of England
city: Shrewsbury
country: United Kingdom
facility: Shrewsburty & Telford Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands
city: Wigan
country: United Kingdom
facility: Wrightington, Wigan and Leigh NHS
Study officials:
affiliation: Imperial College London
name: Jose S Marcano Belisario
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Josip Car
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Cecily Morrison
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: John O'Donoghue
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Ajay Gupta
role: STUDY_CHAIR
affiliation: Imperial College London
name: Paul Ramchandani
role: STUDY_CHAIR
affiliation: University of Dublin, Trinity College
name: Gavin Doherty
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College
name: Kevin Doherty
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.