mHealth for Antenatal Mental Health (AMHS)

Imperial College London

Status: Completed

Conditions: Depression; Pregnancy

Treatments: Other: Contextual questions; Other: Momentary questions; Other: Edinburgh Postnatal Depression Scale; Other: Whooley Questions

Study type: Observational

Funder types: Other

Identifiers

NCT02516982

15IC2687

Details and patient eligibility

About

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.

Full 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.

Enrollment: 946 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

946 participants in 4 patient groups

Screening - Scrolling layout

Description:

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.

Treatment:

Other: Edinburgh Postnatal Depression Scale

Other: Whooley Questions

Screening - Paging layout

Description:

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.

Treatment:

Other: Edinburgh Postnatal Depression Scale

Other: Whooley Questions

Retrospective plus momentary assessment

Description:

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.

Treatment:

Other: Edinburgh Postnatal Depression Scale

Other: Momentary questions

Other: Contextual questions

Retrospective assessment

Description:

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.

Treatment:

Other: Edinburgh Postnatal Depression Scale