Trial Outcomes & Findings for mHealth for Antenatal Mental Health (NCT NCT02516982)
NCT ID: NCT02516982
Last Updated: 2019-09-23
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
946 participants
Primary outcome timeframe
One-off assessment immediately after recruitment
Results posted on
2019-09-23
Participant Flow
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
Participant milestones
| Measure |
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 the 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.
|
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 the 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.
|
Retrospective Plus Momentary Assessment
Participants in this group were asked to download and install an app onto their own smartphones. After that, they were be 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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
305
|
292
|
174
|
175
|
|
Overall Study
COMPLETED
|
273
|
257
|
126
|
125
|
|
Overall Study
NOT COMPLETED
|
32
|
35
|
48
|
50
|
Reasons for withdrawal
| Measure |
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 the 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.
|
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 the 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.
|
Retrospective Plus Momentary Assessment
Participants in this group were asked to download and install an app onto their own smartphones. After that, they were be 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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Called in to antenatal appointment
|
32
|
35
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
1
|
|
Overall Study
Did not install the app
|
0
|
0
|
46
|
47
|
Baseline Characteristics
mHealth for Antenatal Mental Health
Baseline characteristics by cohort
| Measure |
Screening - Scrolling Layout
n=305 Participants
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.
|
Screening - Paging Layout
n=292 Participants
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.
|
Retrospective Plus Momentary Assessment
n=174 Participants
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.
|
Retrospective Assessment
n=175 Participants
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.
|
Total
n=946 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age group · 18 - 22 years
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Age, Customized
Age group · 23 - 27 years
|
51 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
Age, Customized
Age group · 28 - 32 years
|
108 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
341 Participants
n=21 Participants
|
|
Age, Customized
Age group · 33 - 37 years
|
87 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
265 Participants
n=21 Participants
|
|
Age, Customized
Age group · 38+ years
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Women
|
305 Participants
n=5 Participants
|
292 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
946 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnich background · White
|
179 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
153 Participants
n=4 Participants
|
668 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnich background · Mixed
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnich background · Asian
|
70 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
152 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnich background · Black
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnich background · Other
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnich background · Not disclosed
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Relationship status
Single
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
124 Participants
n=21 Participants
|
|
Relationship status
Married/civil partnership
|
201 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
630 Participants
n=21 Participants
|
|
Relationship status
Cohabiting
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Relationship status
Divorced/widowed/separated
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Relationship status
Not disclosed
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Employment status
Full-time employment
|
141 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
464 Participants
n=21 Participants
|
|
Employment status
Part-time employment
|
58 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
190 Participants
n=21 Participants
|
|
Employment status
Self-employed
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Employment status
Seeking employment
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Employment status
Unemployed
|
54 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Employment status
Disability
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Highest educational achievement
Postgraduate degree
|
56 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Highest educational achievement
University degree
|
124 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
429 Participants
n=21 Participants
|
|
Highest educational achievement
College degree or below
|
108 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
282 Participants
n=21 Participants
|
|
Highest educational achievement
None
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Highest educational achievement
Other qualification
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: One-off assessment immediately after recruitmentComparison 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.
Outcome measures
| Measure |
Screening - Scrolling Layout
n=273 Participants
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.
|
Screening - Paging Layout
n=257 Participants
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.
|
|---|---|---|
|
Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout
|
62 Participants
|
60 Participants
|
PRIMARY outcome
Timeframe: One-off assessment immediately after recruitmentThis 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.
Outcome measures
| Measure |
Screening - Scrolling Layout
n=273 Participants
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.
|
Screening - Paging Layout
n=257 Participants
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.
|
|---|---|---|
|
Median EPDS Scores According to Survey Layout
|
3 Score on a scale
Interval 0.0 to 21.0
|
3 Score on a scale
Interval 0.0 to 17.0
|
PRIMARY outcome
Timeframe: One-off assessment immediately after recruitmentNumber 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.
Outcome measures
| Measure |
Screening - Scrolling Layout
n=273 Participants
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.
|
Screening - Paging Layout
n=257 Participants
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.
|
|---|---|---|
|
Number of Participants at Each EPDS Scoring Interval According to Survey Layout
0 - 9 points
|
236 Participants
|
225 Participants
|
|
Number of Participants at Each EPDS Scoring Interval According to Survey Layout
10 - 12 points
|
14 Participants
|
24 Participants
|
|
Number of Participants at Each EPDS Scoring Interval According to Survey Layout
13+ points
|
23 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: One-off assessment immediately after recruitmentNumber 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.
Outcome measures
| Measure |
Screening - Scrolling Layout
n=273 Participants
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.
|
Screening - Paging Layout
n=257 Participants
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.
|
|---|---|---|
|
Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout
0 points
|
268 Participants
|
251 Participants
|
|
Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout
1+ points
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThis 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
Outcome measures
| Measure |
Screening - Scrolling Layout
n=174 Participants
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.
|
Screening - Paging Layout
n=175 Participants
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.
|
|---|---|---|
|
Adherence With a 6-month Follow-up Protocol
|
22 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: One-off assessment immediately after recruitmentThis 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.
Outcome measures
| Measure |
Screening - Scrolling Layout
n=273 Participants
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.
|
Screening - Paging Layout
n=257 Participants
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.
|
|---|---|---|
|
Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout
|
285.5 Seconds
Interval 107.0 to 3444.0
|
333 Seconds
Interval 135.0 to 3146.0
|
SECONDARY outcome
Timeframe: One-off assessment immediately after recruitmentThis 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
Outcome measures
| Measure |
Screening - Scrolling Layout
n=273 Participants
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.
|
Screening - Paging Layout
n=257 Participants
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.
|
|---|---|---|
|
Proportion of Participants Requesting Technical Assistance According to Survey Layout
No requests
|
254 Participants
|
241 Participants
|
|
Proportion of Participants Requesting Technical Assistance According to Survey Layout
Requests made
|
19 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consentThis 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.
Outcome measures
| Measure |
Screening - Scrolling Layout
n=19 Requests for technical assistance
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.
|
Screening - Paging Layout
n=16 Requests for technical assistance
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.
|
|---|---|---|
|
Number of Requests for Technical Assistance by Type of Request and According to Survey Layout
Clarification of questions
|
14 Requests for technical assistance
|
11 Requests for technical assistance
|
|
Number of Requests for Technical Assistance by Type of Request and According to Survey Layout
Interface issues
|
1 Requests for technical assistance
|
1 Requests for technical assistance
|
|
Number of Requests for Technical Assistance by Type of Request and According to Survey Layout
Navigation issues
|
0 Requests for technical assistance
|
3 Requests for technical assistance
|
|
Number of Requests for Technical Assistance by Type of Request and According to Survey Layout
Not recorded
|
4 Requests for technical assistance
|
1 Requests for technical assistance
|
Adverse Events
Screening - Scrolling Layout
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Screening - Paging Layout
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Retrospective Plus Momentary Assessment
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Retrospective Assessment
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Screening - Scrolling Layout
n=273 participants at risk
Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and the 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.
|
Screening - Paging Layout
n=257 participants at risk
Participants were asked to complete the following surveys using an iPad in the waiting area of antenatal clinics: Demographic information survey; Whooley questions; and the 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.
|
Retrospective Plus Momentary Assessment
n=174 participants at risk
Participants in this group were asked to download and install an app onto their own smartphones. After that, they were be 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.
|
Retrospective Assessment
n=175 participants at risk
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.
|
|---|---|---|---|---|
|
Psychiatric disorders
Thirteen points or more on the EPDS during a six-month follow up
|
—
0/0 • 6 months
Participants did not receive a medical intervention. Therefore, no mortality or serious adverse events were expected in this trial. We defined adverse events as those pregnant women who scored above the recommended threshold for the EPDS (i.e., 13 points or more) and had to be referred to specialist mental health services as a result of this.
|
—
0/0 • 6 months
Participants did not receive a medical intervention. Therefore, no mortality or serious adverse events were expected in this trial. We defined adverse events as those pregnant women who scored above the recommended threshold for the EPDS (i.e., 13 points or more) and had to be referred to specialist mental health services as a result of this.
|
14.4%
25/174 • Number of events 37 • 6 months
Participants did not receive a medical intervention. Therefore, no mortality or serious adverse events were expected in this trial. We defined adverse events as those pregnant women who scored above the recommended threshold for the EPDS (i.e., 13 points or more) and had to be referred to specialist mental health services as a result of this.
|
14.9%
26/175 • Number of events 51 • 6 months
Participants did not receive a medical intervention. Therefore, no mortality or serious adverse events were expected in this trial. We defined adverse events as those pregnant women who scored above the recommended threshold for the EPDS (i.e., 13 points or more) and had to be referred to specialist mental health services as a result of this.
|
|
Psychiatric disorders
Thirteen points or more on the EPDS at baseline
|
8.4%
23/273 • Number of events 23 • 6 months
Participants did not receive a medical intervention. Therefore, no mortality or serious adverse events were expected in this trial. We defined adverse events as those pregnant women who scored above the recommended threshold for the EPDS (i.e., 13 points or more) and had to be referred to specialist mental health services as a result of this.
|
3.1%
8/257 • Number of events 8 • 6 months
Participants did not receive a medical intervention. Therefore, no mortality or serious adverse events were expected in this trial. We defined adverse events as those pregnant women who scored above the recommended threshold for the EPDS (i.e., 13 points or more) and had to be referred to specialist mental health services as a result of this.
|
3.4%
6/174 • Number of events 6 • 6 months
Participants did not receive a medical intervention. Therefore, no mortality or serious adverse events were expected in this trial. We defined adverse events as those pregnant women who scored above the recommended threshold for the EPDS (i.e., 13 points or more) and had to be referred to specialist mental health services as a result of this.
|
5.1%
9/175 • Number of events 9 • 6 months
Participants did not receive a medical intervention. Therefore, no mortality or serious adverse events were expected in this trial. We defined adverse events as those pregnant women who scored above the recommended threshold for the EPDS (i.e., 13 points or more) and had to be referred to specialist mental health services as a result of this.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place