N/A
N=946
mHealth for Antenatal Mental Health
Depression · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02516982 ↗Enrolled (actual)
946
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout — 62; 60 Participants — p=0.994
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Whooley Questions (Other); Edinburgh Postnatal Depression Scale (Other); Momentary questions (Other); Contextual questions (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Imperial College London
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout |
62; 60 | 0.994 |
| PRIMARY Median EPDS Scores According to Survey Layout |
3; 3 | 0.7 |
| PRIMARY Number of Participants at Each EPDS Scoring Interval According to Survey Layout |
236; 225; 14; 24; 23; 8 | 0.008 sig |
| PRIMARY Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout |
268; 251; 5; 6 | 0.919 |
| PRIMARY Adherence With a 6-month Follow-up Protocol |
22; 3 | 0.0001467 sig |
| SECONDARY Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout |
285.5; 333 | 0.024 sig |
| SECONDARY Proportion of Participants Requesting Technical Assistance According to Survey Layout |
254; 241; 19; 16 | 0.869 |
| SECONDARY Number of Requests for Technical Assistance by Type of Request and According to Survey Layout |
14; 11; 1; 1; 0; 3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02516982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.