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Trial record 29 of 200 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

mHealth for Antenatal Mental Health (AMHS)

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ClinicalTrials.gov Identifier: NCT02516982
Recruitment Status : Recruiting
First Posted : August 6, 2015
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Depression Pregnancy Other: Whooley Questions Other: Edinburgh Postnatal Depression Scale Other: Momentary questions Other: Contextual questions

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

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Tablet Computers for Implementing NICE Antenatal Mental Health Guidelines - Feasibility Study
Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.

Other: Whooley Questions
The Whooley questions are a case-finding instrument for depression in primary care. This 2-question instrument screens for depressed mood and anhedonia that have been present during the past month. Respondents are required to answer Yes or No to each of these questions. An affirmative answer to any of them should be followed by further assessment, including the use of a validated screening instrument or referral to a general practitioner or a mental health practitioner.
Other: Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
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.

Other: Whooley Questions
The Whooley questions are a case-finding instrument for depression in primary care. This 2-question instrument screens for depressed mood and anhedonia that have been present during the past month. Respondents are required to answer Yes or No to each of these questions. An affirmative answer to any of them should be followed by further assessment, including the use of a validated screening instrument or referral to a general practitioner or a mental health practitioner.
Other: Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
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.
Other: Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
Other: Momentary questions
These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry.
Other: Contextual questions
Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions.
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.
Other: Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.


Outcome Measures

Primary Outcome Measures :
  1. Positive predictive value of the Whooley questions [ Time Frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent ]
    Overall, we will calculate the number of pregnant women who answered Yes to any of the Whooley questions AND who scored 10 points or higher on the Edinburgh Postnatal Depression Scale (EPDS), as a proportion of the total number of pregnant women who answered Yes to any of the Whooley questions regardless of their EPDS scores.

  2. Negative predictive value of the Whooley questions [ Time Frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent ]
    Overall, we will calculate the number of pregnant women who answered No to both Whooley questions AND who scored 9 points or lower on the Edinburgh Postnatal Depression Scale (EPDS), as a proportion of the total number of pregnant women who answered No to both Whooley questions regardless of their EPDS scores.

  3. False Omission Rate of the Whooley questions [ Time Frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent ]
    Overall, we will calculate the number of pregnant women who answered No to both Whooley questions AND who scored 10 points or higher on the Edinburgh Postnatal Depression Scale (EPDS), as a proportion of the total number of pregnant women who answered No to both Whooley questions regardless of their EPDS scores.

  4. Adherence to sampling protocol [ Time Frame: Assessed after 6 months ]
    Proportion of expected assessments that were completed as a proportion of the total number of expected assessments.


Secondary Outcome Measures :
  1. Mean overall scores on the Edinburgh Postnatal Depression Scale [ Time Frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent ]
  2. Breakoff rates [ Time Frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent ]
    Proportion of participants who interrupt the survey completion process before reaching the end of the survey questionnaires (i.e., breakoff rates). In such eventualities, we will document the reason for breakoff.

  3. Time needed to complete survey questionnaires [ Time Frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent ]
    This will be the 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.

  4. Proportion of complete records [ Time Frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent ]
    A complete record will be defined as one in which no question was left unanswered. Leaving unanswered questions will not be possible due to the implementation of validation procedures. Therefore, data completeness will be indicated by the breakoff rates.


Other Outcome Measures:
  1. Proportion of participants requesting help [ Time Frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent ]
    We will document the requests for help made by each participant, as well as the nature of the request. We will categorise participants into 3 groups: (i) one request for help; (ii) between 2 and 4 requests for help; and (iii) 5 or more requests for help. Subsequently, for each experimental group, we will compute the proportion of participants falling within each category.

  2. Proportion of each type of request for help [ Time Frame: One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent ]
    We will document the requests for help made by each participant. We will conduct a content analysis of these requests in order to categorise them according to their nature. For each experimental group, we will compute the proportion of participants making each type of request.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women who are 18 years old or older.
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516982


Contacts
Contact: Jose S Marcano Belisario +44(0)2075940771 jose.marcano@imperial.ac.uk

Locations
United Kingdom
East Lancashire Active, not recruiting
Blackburn, United Kingdom
Royal Bolton Hospital Active, not recruiting
Bolton, United Kingdom
Burton Hospitals Recruiting
Burton, United Kingdom
Contact: Jane Radford         
Contact: Anne Hogg         
The Pennine Acute Hospitals Active, not recruiting
Crumpsall, United Kingdom
Hinchinbrooke Hospital Recruiting
Huntingdon, United Kingdom
Contact: Tara Pauley         
Contact: Charlotte Clayton         
East Midlands CRN Completed
Lincoln, United Kingdom
Chelsea & Westminster Hospital Recruiting
London, United Kingdom
Contact: Minna Meritahti         
Hillingdon Hospitals Active, not recruiting
London, United Kingdom
Northwick Park Hospital Completed
London, United Kingdom
West Middlesex Hospital Active, not recruiting
London, United Kingdom
North of England Recruiting
Newcastle, United Kingdom
Contact: Siobhan Limerick         
Shrewsburty & Telford Hospital Active, not recruiting
Shrewsbury, United Kingdom
University Hospitals of North Midlands Recruiting
Stoke-on-Trent, United Kingdom
Contact: Anna Fleming         
Wrightington, Wigan and Leigh NHS Active, not recruiting
Wigan, United Kingdom
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Jose S Marcano Belisario Imperial College London
Principal Investigator: Josip Car Imperial College London
Principal Investigator: Cecily Morrison Imperial College London
Principal Investigator: John O'Donoghue Imperial College London
Study Chair: Ajay Gupta Imperial College London
Study Chair: Paul Ramchandani Imperial College London
Principal Investigator: Gavin Doherty Trinity College Dublin
Principal Investigator: Kevin Doherty Trinity College Dublin
More Information

Publications:
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02516982     History of Changes
Other Study ID Numbers: 15IC2687
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Imperial College London:
Mental health
mHealth
Telemedicine
Perinatal depression
Screening
Edinburgh Postnatal Depression Scale
Whooley Questions
Data collection
Mood disorders
Antenatal care
Prenatal Care

Additional relevant MeSH terms:
Depression
Behavioral Symptoms