DepressionAMHSNCT02516982
mHealth for Antenatal Mental Health
An observational study of Depression and Pregnancy, run by Imperial College London at 14 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Pregnancy
- What is being tested?
- Whooley Questions, Edinburgh Postnatal Depression Scale and Momentary questions
- Type of treatment
- Pill or oral medicine
- How many people
- 946 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- Oct 2015to Aug 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women who are 18 years old or older.
Who may be able to join
- Pregnant women attending antenatal clinics
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
East Lancashire
Blackburn
Royal Bolton Hospital
Bolton
Burton Hospitals
Burton
The Pennine Acute Hospitals
Crumpsall
Hinchinbrooke Hospital
Huntingdon
East Midlands CRN
Lincoln
Chelsea & Westminster Hospital
London
Hillingdon Hospitals
London
Northwick Park Hospital
London
West Middlesex Hospital
London
North of England
Newcastle
Shrewsburty & Telford Hospital
Shrewsbury
University Hospitals of North Midlands
Stoke-on-Trent
Wrightington, Wigan and Leigh NHS
Wigan
About this study
Official title: Tablet Computers for Implementing NICE Antenatal Mental Health Guidelines - Feasibility Study
The aim of this study is to determine the feasibility of using mobile technology for:
- 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
- Using a bespoke app running on pregnant women's own smartphones to monitor mood and symptoms of depression throughout pregnancy.
Read the 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.
- Conditions
- Depression, Pregnancy
- Being tested
- Whooley Questions, Edinburgh Postnatal Depression Scale, Momentary questions, Contextual questions
- Keywords
- mHealth, Telemedicine, Perinatal depression, Screening, Edinburgh Postnatal Depression Scale, Whooley Questions, Data collection, Mood disorders, Mental health, Antenatal care, Prenatal Care
- Medical subject headings
- Depression, Mood Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whooley QuestionsOther
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.
Edinburgh Postnatal Depression ScaleOther
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.
Momentary questionsOther
These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry.
Contextual questionsOther
Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Edinburgh Postnatal Depression Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 months
Secondary outcomes (3)
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.
Measured: One-off assessment immediately after recruitment
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
Measured: One-off assessment immediately after recruitment
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.
Measured: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 946 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose S Marcano Belisario, Principal investigator, Imperial College LondonJosip Car, Principal investigator, Imperial College LondonCecily Morrison, Principal investigator, Imperial College LondonJohn O'Donoghue, Principal investigator, Imperial College LondonAjay Gupta, Study chair, Imperial College LondonPaul Ramchandani, Study chair, Imperial College LondonGavin Doherty, Principal investigator, University of Dublin, Trinity CollegeKevin Doherty, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516982
- Sponsor's protocol ID
- 15IC2687
- Acronym
- AMHS
- Status last verified
- Sep 2019
- First submitted
- 20 Jul 2015
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26801468Marcano 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.
PubMed 28554914Marcano-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.
PubMed 28490353
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tablet Computers for Implementing NICE Antenatal Mental Health Guidelines - Feasibility Study
- ClinicalTrials.gov ID
- NCT02516982
- Acronym / sponsor ID
- AMHS / 15IC2687
- Conditions
- Depression, Pregnancy
- Keywords
- mHealth, Telemedicine, Perinatal depression, Screening, Edinburgh Postnatal Depression Scale, Whooley Questions, Data collection, Mood disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 946 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Posted 23 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the feasibility of using mobile technology for:
- 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
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Screening - Scrolling layout | – | Other: Whooley Questions, Other: Edinburgh Postnatal Depression ScaleParticipants 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. |
| Screening - Paging layout | – | Other: Whooley Questions, Other: Edinburgh Postnatal Depression ScaleParticipants 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. |
| Retrospective plus momentary assessment | – | Other: Edinburgh Postnatal Depression Scale, Other: Momentary questions, Other: Contextual questionsParticipants 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. |
| Retrospective assessment | – | Other: Edinburgh Postnatal Depression ScaleParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who are 18 years old or older.
Key inclusion criteria (1 listed)
- Pregnant women attending antenatal clinics
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whooley QuestionsThe 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 | Screening - Paging layout, Screening - Scrolling layout |
| Edinburgh Postnatal Depression ScaleThe 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 | Retrospective assessment, Retrospective plus momentary assessment, Screening - Paging layout, Screening - Scrolling layout |
| Momentary questionsThese will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry. | Other | Retrospective plus momentary assessment |
| Contextual questionsTwo questions asking for participants' location and activity at the time they were asked to complete the momentary questions. | Other | Retrospective plus momentary assessment |
Primary outcome
Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout
Time frame: 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.
Median EPDS Scores According to Survey Layout
Time frame: 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
Time frame: 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
Time frame: 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.
Adherence With a 6-month Follow-up Protocol
Time frame: 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
3 secondary outcomes
Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout
Time frame: One-off assessment immediately after recruitment
Proportion of Participants Requesting Technical Assistance According to Survey Layout
Time frame: One-off assessment immediately after recruitment
Number of Requests for Technical Assistance by Type of Request and According to Survey Layout
Time frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26801468Marcano-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.
- Background: PubMed 28554914Marcano 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.
- Results publication: PubMed 28490353Marcano-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose S Marcano Belisario principal investigator
Imperial College London
Josip Car principal investigator
Imperial College London
Cecily Morrison principal investigator
Imperial College London
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Pregnancy, run by Imperial College London at 14 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout (time frame: One-off assessment immediately after recruitment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02516982, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.