NCT02516982

mHealth for Antenatal Mental Health

Tablet Computers for Implementing NICE Antenatal Mental Health Guidelines - Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 946 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depression
• Pregnancy

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	Momentary questions	These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry.
OTHER	Contextual questions	Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions.

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-02-01
• Completion: 2018-08-01
• First posted: 2015-08-06
• Last updated: 2019-09-23
• Results posted: 2019-09-23

Locations

14 sites across 1 country: United Kingdom