mHealth for Antenatal Mental Health

NCT02516982 | Completed Results

• 1 other identifier: 15IC2687
• Study Type: observational
• Target: 946
• Locations: 1 country
• Sites: 14

Brief Summary

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

1. 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. 2.Using a bespoke app running on pregnant women's own smartphones to monitor mood and symptoms of depression throughout pregnancy.

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout

  One-off assessment immediately after recruitment

• Proportion of Participants Requesting Technical Assistance According to Survey Layout

  One-off assessment immediately after recruitment

• 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

Study Arms (4)

Screening - Scrolling layout

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.

Other: Whooley Questions; Other: Edinburgh Postnatal Depression Scale

Screening - Paging layout

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.

Other: Whooley Questions; Other: Edinburgh Postnatal Depression Scale

Retrospective plus momentary assessment

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.

Other: Edinburgh Postnatal Depression Scale; Other: Momentary questions; Other: Contextual questions

Retrospective assessment

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.

Other: Edinburgh Postnatal Depression Scale

Interventions

Whooley Questions OTHER

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.

Screening - Paging layout; Screening - Scrolling layout

Edinburgh Postnatal Depression Scale OTHER

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.

Retrospective assessment; Retrospective plus momentary assessment; Screening - Paging layout; Screening - Scrolling layout

Momentary questions OTHER

These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry.

Retrospective plus momentary assessment

Contextual questions OTHER

Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions.

Retrospective plus momentary assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women who are 18 years old or older.

You may qualify if:

• Pregnant women attending antenatal clinics

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (14)

East Lancashire

Blackburn, United Kingdom

Location

Royal Bolton Hospital

Bolton, United Kingdom

Location

Burton Hospitals

Burton, United Kingdom

Location

The Pennine Acute Hospitals

Crumpsall, United Kingdom

Location

Hinchinbrooke Hospital

Huntingdon, United Kingdom

Location

East Midlands CRN

Lincoln, United Kingdom

Location

Chelsea & Westminster Hospital

London, United Kingdom

Location

Hillingdon Hospitals

London, United Kingdom

Location

Northwick Park Hospital

London, United Kingdom

Location

West Middlesex Hospital

London, United Kingdom

Location

North of England

Newcastle, United Kingdom

Location

Shrewsburty & Telford Hospital

Shrewsbury, United Kingdom

Location

University Hospitals of North Midlands

Stoke-on-Trent, United Kingdom

Location

Wrightington, Wigan and Leigh NHS

Wigan, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 26801468 BACKGROUND

• 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.

  PMID: 28554914 BACKGROUND

• 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.

  PMID: 28490353 RESULT

MeSH Terms

Conditions

Depression; Mood Disorders; Psychological Well-Being

Interventions

Psychiatric Status Rating Scales

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr Josip Car
• Organization: Imperial College London

josip.car@imperial.ac.uk

+44(0)2075940799

Study Officials

• Jose S Marcano Belisario

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Josip Car

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Cecily Morrison

  Imperial College London

  PRINCIPAL INVESTIGATOR

• John O'Donoghue

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Ajay Gupta

  Imperial College London

  STUDY CHAIR

• Paul Ramchandani

  Imperial College London

  STUDY CHAIR

• Gavin Doherty

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

• Kevin Doherty

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: August 6, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 23, 2019
• Results First Posted: September 23, 2019

Record last verified: 2019-09

Locations

GB (14)