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The aim of this study is to determine the feasibility of using mobile technology for:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening - Scrolling layout | Participants will be asked to complete a survey consisting of three sections using an iPad Air tablet:
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 | Participants will be asked to complete a survey consisting of three sections using an iPad Air tablet:
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 | 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. |
| |
| Retrospective assessment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whooley Questions | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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Pregnant women who are 18 years old or older.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Ajay Gupta | Imperial College London | Study Chair |
| Paul Ramchandani | Imperial College London | Study Chair |
| Gavin Doherty | University of Dublin, Trinity College | Principal Investigator |
| Kevin Doherty | University of Dublin, Trinity College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Lancashire | Blackburn | United Kingdom | ||||
| Royal Bolton Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26801468 | Background | 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. | |
| 28554914 | Background | Marcano 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2017 |
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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.
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| Edinburgh Postnatal Depression Scale | Other | 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. |
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| Momentary questions | Other | These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry. |
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| Contextual questions | Other | Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions. |
|
| 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 | 6 months |
| 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 | 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. | One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent |
| Bolton |
| United Kingdom |
| Burton Hospitals | Burton | United Kingdom |
| The Pennine Acute Hospitals | Crumpsall | United Kingdom |
| Hinchinbrooke Hospital | Huntingdon | United Kingdom |
| East Midlands CRN | Lincoln | United Kingdom |
| Chelsea & Westminster Hospital | London | United Kingdom |
| Hillingdon Hospitals | London | United Kingdom |
| Northwick Park Hospital | London | United Kingdom |
| West Middlesex Hospital | London | United Kingdom |
| North of England | Newcastle | United Kingdom |
| Shrewsburty & Telford Hospital | Shrewsbury | United Kingdom |
| University Hospitals of North Midlands | Stoke-on-Trent | United Kingdom |
| Wrightington, Wigan and Leigh NHS | Wigan | United Kingdom |
| 28490353 | Result | Marcano-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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Relationship status | Count of Participants | Participants |
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| Employment status | Count of Participants | Participants |
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| Highest educational achievement | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Posted | Count of Participants | Participants | One-off assessment immediately after recruitment |
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| 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. | Posted | Median | Full Range | Score on a scale | One-off assessment immediately after recruitment |
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| 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. | Posted | Count of Participants | Participants | One-off assessment immediately after recruitment |
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| 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. | Posted | Count of Participants | Participants | One-off assessment immediately after recruitment |
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| 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 | Posted | Count of Participants | Participants | 6 months |
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| 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. | Posted | Median | Full Range | Seconds | One-off assessment immediately after recruitment |
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| 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 | Posted | Count of Participants | Participants | One-off assessment immediately after recruitment |
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| 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. | Posted | Number | Requests for technical assistance | One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent | Requests for technical assistance | Requests for technical assistance |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 273 | 0 | 273 | 23 | 273 |
| EG001 | 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. | 0 | 257 | 0 | 257 | 8 | 257 |
| EG002 | 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. | 0 | 174 | 0 | 174 | 25 | 174 |
| EG003 | 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. | 0 | 175 | 0 | 175 | 26 | 175 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thirteen points or more on the EPDS at baseline | Psychiatric disorders | Systematic Assessment | Scoring 13 points or more on the EPDS |
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| Thirteen points or more on the EPDS during a six-month follow up | Psychiatric disorders | Systematic Assessment | Scoring 13 points or more on the EPDS at any point during 6 month follow-up |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Josip Car | Imperial College London | +44(0)2075940799 | josip.car@imperial.ac.uk |
| May 13, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D019964 | Mood Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D011569 | Psychiatric Status Rating Scales |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| 23 - 27 years |
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| 28 - 32 years |
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| 33 - 37 years |
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| 38+ years |
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| Mixed |
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| Asian |
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| Black |
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| Other |
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| Not disclosed |
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| Married/civil partnership |
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| Cohabiting |
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| Divorced/widowed/separated |
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| Not disclosed |
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| Part-time employment |
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| Self-employed |
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| Seeking employment |
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| Unemployed |
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| Disability |
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| University degree |
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| College degree or below |
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| None |
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| Other qualification |
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