mHealth for Antenatal Mental Health

NCT02516982 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 946

Last updated 2019-09-23

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Jose S Marcano Belisario · Imperial College London

  • Josip Car · Imperial College London

  • Cecily Morrison · Imperial College London

  • John O'Donoghue · Imperial College London

  • Ajay Gupta · Imperial College London

  • Paul Ramchandani · Imperial College London

  • Gavin Doherty · University of Dublin, Trinity College

  • Kevin Doherty · University of Dublin, Trinity College

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-02-28
Completion
2018-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02516982 on ClinicalTrials.gov