Depression, Pregnancy
Conditions
Keywords
mHealth, Telemedicine, Perinatal depression, Screening, Edinburgh Postnatal Depression Scale, Whooley Questions, Data collection, Mood disorders, Mental health, Antenatal care, Prenatal Care
Brief 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.
Interventions
OTHERWhooley 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.
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.
OTHERMomentary questions
These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry.
OTHERContextual questions
Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions.
Sponsors
Imperial College London
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence With a 6-month Follow-up Protocol | 6 months | 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 |
| Median EPDS Scores According to Survey Layout | One-off assessment immediately after recruitment | 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. |
| Number of Participants at Each EPDS Scoring Interval According to Survey Layout | One-off assessment immediately after recruitment | 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. |
| Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout | One-off assessment immediately after recruitment | 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. |
| Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout | One-off assessment immediately after recruitment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Requesting Technical Assistance According to Survey Layout | One-off assessment immediately after recruitment | 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 |
| 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 | 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. |
| Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout | One-off assessment immediately after recruitment | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Phase 1: Scrolling vs Paging layouts - Recruitment dates: October 2015 to May 2016 Phase 2: Momentary vs Momentary plus Retrospective - Recruitment dates: April 2017 tp August 2017
Participants by arm
| Arm | Count |
|---|---|
| Screening - Scrolling Layout Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and Edinburgh Postnatal Depression Scale.
All questions were presented on a single screen. This means that participants had to scroll vertically to answer all the questions. | 305 |
| Screening - Paging Layout Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and Edinburgh Postnatal Depression Scale.
Only one question was displayed on the screen at any given time. This means that participants had to navigate through multiple pages in order to answer all the questions. | 292 |
| Retrospective Plus Momentary Assessment Participants in this group were asked to download and install an app onto their own smartphones. After that, they were asked to complete a sampling protocol consisting of 6 consecutive days, once a month for 6 months. During the 6 assessment days, participants were required to complete the Edinburgh Postnatal Depression Scale, 5 momentary questions on a 5-point pictorial scale, and 2 contextual questions. | 174 |
| Retrospective Assessment Participants in this group were asked to download and install an app onto their own smartphones. After that, they were asked to complete a sampling protocol consisting of one day a month for 6 months. The assessment days consisted of a single administration of the Edinburgh Postnatal Depression Scale. | 175 |
| Total | 946 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Called in to antenatal appointment | 32 | 35 | 0 | 0 |
| Overall Study | Did not install the app | 0 | 0 | 46 | 47 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Screening - Scrolling Layout | Screening - Paging Layout | Retrospective Plus Momentary Assessment | Retrospective Assessment | Total |
|---|---|---|---|---|---|
| Age, Customized Age group 18 - 22 years | 23 Participants | 19 Participants | 17 Participants | 10 Participants | 69 Participants |
| Age, Customized Age group 23 - 27 years | 51 Participants | 45 Participants | 32 Participants | 46 Participants | 174 Participants |
| Age, Customized Age group 28 - 32 years | 108 Participants | 113 Participants | 57 Participants | 63 Participants | 341 Participants |
| Age, Customized Age group 33 - 37 years | 87 Participants | 85 Participants | 49 Participants | 44 Participants | 265 Participants |
| Age, Customized Age group 38+ years | 36 Participants | 30 Participants | 19 Participants | 12 Participants | 97 Participants |
| Employment status Disability | 11 Participants | 6 Participants | 0 Participants | 0 Participants | 17 Participants |
| Employment status Full-time employment | 141 Participants | 148 Participants | 93 Participants | 82 Participants | 464 Participants |
| Employment status Part-time employment | 58 Participants | 54 Participants | 38 Participants | 40 Participants | 190 Participants |
| Employment status Seeking employment | 11 Participants | 19 Participants | 3 Participants | 8 Participants | 41 Participants |
| Employment status Self-employed | 30 Participants | 26 Participants | 16 Participants | 22 Participants | 94 Participants |
| Employment status Unemployed | 54 Participants | 39 Participants | 24 Participants | 23 Participants | 140 Participants |
| Highest educational achievement College degree or below | 108 Participants | 110 Participants | 31 Participants | 33 Participants | 282 Participants |
| Highest educational achievement None | 8 Participants | 6 Participants | 1 Participants | 8 Participants | 23 Participants |
| Highest educational achievement Other qualification | 9 Participants | 11 Participants | 49 Participants | 34 Participants | 103 Participants |
| Highest educational achievement Postgraduate degree | 56 Participants | 53 Participants | 0 Participants | 0 Participants | 109 Participants |
| Highest educational achievement University degree | 124 Participants | 112 Participants | 93 Participants | 100 Participants | 429 Participants |
| Race/Ethnicity, Customized Ethnich background Asian | 70 Participants | 51 Participants | 16 Participants | 15 Participants | 152 Participants |
| Race/Ethnicity, Customized Ethnich background Black | 20 Participants | 21 Participants | 0 Participants | 0 Participants | 41 Participants |
| Race/Ethnicity, Customized Ethnich background Mixed | 15 Participants | 13 Participants | 3 Participants | 1 Participants | 32 Participants |
| Race/Ethnicity, Customized Ethnich background Not disclosed | 3 Participants | 0 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnich background Other | 18 Participants | 17 Participants | 6 Participants | 6 Participants | 47 Participants |
| Race/Ethnicity, Customized Ethnich background White | 179 Participants | 190 Participants | 146 Participants | 153 Participants | 668 Participants |
| Relationship status Cohabiting | 74 Participants | 72 Participants | 0 Participants | 0 Participants | 146 Participants |
| Relationship status Divorced/widowed/separated | 3 Participants | 7 Participants | 2 Participants | 2 Participants | 14 Participants |
| Relationship status Married/civil partnership | 201 Participants | 187 Participants | 126 Participants | 116 Participants | 630 Participants |
| Relationship status Not disclosed | 3 Participants | 5 Participants | 10 Participants | 14 Participants | 32 Participants |
| Relationship status Single | 24 Participants | 21 Participants | 36 Participants | 43 Participants | 124 Participants |
| Sex/Gender, Customized Women | 305 Participants | 292 Participants | 174 Participants | 175 Participants | 946 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 273 | 0 / 257 | 0 / 174 | 0 / 175 |
| other Total, other adverse events | 23 / 273 | 8 / 257 | 25 / 174 | 26 / 175 |
| serious Total, serious adverse events | 0 / 273 | 0 / 257 | 0 / 174 | 0 / 175 |
Outcome results
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
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening - Scrolling Layout | Adherence With a 6-month Follow-up Protocol | 22 Participants |
| Screening - Paging Layout | Adherence With a 6-month Follow-up Protocol | 3 Participants |
p-value: 0.0001467Chi-squared, Corrected
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.
Time frame: One-off assessment immediately after recruitment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Screening - Scrolling Layout | Median EPDS Scores According to Survey Layout | 3 Score on a scale |
| Screening - Paging Layout | Median EPDS Scores According to Survey Layout | 3 Score on a scale |
p-value: 0.7Wilcoxon (Mann-Whitney)
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.
Time frame: One-off assessment immediately after recruitment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening - Scrolling Layout | Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout | 0 points | 268 Participants |
| Screening - Scrolling Layout | Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout | 1+ points | 5 Participants |
| Screening - Paging Layout | Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout | 0 points | 251 Participants |
| Screening - Paging Layout | Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout | 1+ points | 6 Participants |
p-value: 0.919Chi-squared, Corrected
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.
Time frame: One-off assessment immediately after recruitment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening - Scrolling Layout | Number of Participants at Each EPDS Scoring Interval According to Survey Layout | 0 - 9 points | 236 Participants |
| Screening - Scrolling Layout | Number of Participants at Each EPDS Scoring Interval According to Survey Layout | 10 - 12 points | 14 Participants |
| Screening - Scrolling Layout | Number of Participants at Each EPDS Scoring Interval According to Survey Layout | 13+ points | 23 Participants |
| Screening - Paging Layout | Number of Participants at Each EPDS Scoring Interval According to Survey Layout | 0 - 9 points | 225 Participants |
| Screening - Paging Layout | Number of Participants at Each EPDS Scoring Interval According to Survey Layout | 10 - 12 points | 24 Participants |
| Screening - Paging Layout | Number of Participants at Each EPDS Scoring Interval According to Survey Layout | 13+ points | 8 Participants |
p-value: 0.008Chi-squared, Corrected
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.
Time frame: One-off assessment immediately after recruitment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening - Scrolling Layout | Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout | 62 Participants |
| Screening - Paging Layout | Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout | 60 Participants |
p-value: 0.994Chi-squared, Corrected
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.
Time frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Screening - Scrolling Layout | Number of Requests for Technical Assistance by Type of Request and According to Survey Layout | Interface issues | 1 Requests for technical assistance |
| Screening - Scrolling Layout | Number of Requests for Technical Assistance by Type of Request and According to Survey Layout | Not recorded | 4 Requests for technical assistance |
| Screening - Scrolling Layout | Number of Requests for Technical Assistance by Type of Request and According to Survey Layout | Navigation issues | 0 Requests for technical assistance |
| Screening - Scrolling Layout | Number of Requests for Technical Assistance by Type of Request and According to Survey Layout | Clarification of questions | 14 Requests for technical assistance |
| Screening - Paging Layout | Number of Requests for Technical Assistance by Type of Request and According to Survey Layout | Interface issues | 1 Requests for technical assistance |
| Screening - Paging Layout | Number of Requests for Technical Assistance by Type of Request and According to Survey Layout | Clarification of questions | 11 Requests for technical assistance |
| Screening - Paging Layout | Number of Requests for Technical Assistance by Type of Request and According to Survey Layout | Navigation issues | 3 Requests for technical assistance |
| Screening - Paging Layout | Number of Requests for Technical Assistance by Type of Request and According to Survey Layout | Not recorded | 1 Requests for technical assistance |
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
Time frame: One-off assessment immediately after recruitment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening - Scrolling Layout | Proportion of Participants Requesting Technical Assistance According to Survey Layout | No requests | 254 Participants |
| Screening - Scrolling Layout | Proportion of Participants Requesting Technical Assistance According to Survey Layout | Requests made | 19 Participants |
| Screening - Paging Layout | Proportion of Participants Requesting Technical Assistance According to Survey Layout | No requests | 241 Participants |
| Screening - Paging Layout | Proportion of Participants Requesting Technical Assistance According to Survey Layout | Requests made | 16 Participants |
p-value: 0.869Chi-squared, Corrected
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.
Time frame: One-off assessment immediately after recruitment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Screening - Scrolling Layout | Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout | 285.5 Seconds |
| Screening - Paging Layout | Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout | 333 Seconds |
p-value: 0.024Wilcoxon (Mann-Whitney)