mHealth for Antenatal Mental Health

Depression Clinical Trial

— AMHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516982
• Other study ID #: 15IC2687
• Status: Completed
• Start date: October 2015
• Est. completion date: August 2018

Study information

• Verified date: September 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 946
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout	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.	One-off assessment immediately after recruitment
Primary	Median EPDS Scores According to Survey Layout	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.	One-off assessment immediately after recruitment
Primary	Number of Participants at Each EPDS Scoring Interval According to Survey Layout	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.	One-off assessment immediately after recruitment
Primary	Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout	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.	One-off assessment immediately after recruitment
Primary	Adherence With a 6-month Follow-up Protocol	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	6 months
Secondary	Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout	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.	One-off assessment immediately after recruitment
Secondary	Proportion of Participants Requesting Technical Assistance According to Survey Layout	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	One-off assessment immediately after recruitment
Secondary	Number of Requests for Technical Assistance by Type of Request and According to Survey Layout	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.	One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent