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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| Uppsala University | OTHER |
| Intensive Care Society | UNKNOWN |
| University of Nottingham |
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Intensive care unit (ICU) staff are frequently exposed to traumatic events at work (e.g., witnessing patients die), amplified by the COVID-19 pandemic. A significant proportion experience intrusive memories of these events that pop suddenly into mind: these imagery-based memories can disrupt functioning and contribute to posttraumatic stress disorder. Previous research has shown that a brief behavioural intervention can reduce the number of intrusive memories after a traumatic event. In this study we aim to optimise a brief digital intervention to help reduce the number of intrusive memories experienced by ICU staff (primary outcome). We will explore if it can improve work functioning and wellbeing (secondary outcomes). We will recruit approximately 150 ICU staff with intrusive memories of events experienced during the COVID-19 pandemic.
The study is funded by the Wellcome Trust (223016/Z/21/Z).
A statistical analysis plan was prepared prior to the first interim analysis for the outcomes that guided study optimisation, i.e., primarily the primary outcome.
A second statistical analysis plan was prepared prior to the end of the study, outlining the standard (frequentist) statistical approaches used to analyse the primary, secondary and tertiary data.
Regular monitoring performed by P1vital Products to verify that the study is conducted and data are generated, documented and reported in compliance with the protocol, GCP and the applicable regulatory requirements.
Quality assurance representatives from the Sponsor may carry out an audit of the study in compliance with regulatory guidelines and relevant standard operating procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate intervention arm | Experimental | Immediate access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome). |
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| Delayed intervention arm | Experimental | Usual care for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome), followed by access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief digital imagery-competing task intervention | Behavioral | First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions. Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Intrusive Memories of Traumatic Event(s) | Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days at week 4 (i.e., Day 22-28). To control for the number of intrusive memories recorded by participants in each experimental group during the run-in/screening week, we included the baseline count of intrusive memories (along with binary arm status) as fixed effect covariates in the Poisson regression model used for primary analysis. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Intrusive Memories of Traumatic Event(s) | Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days. Total number of intrusive memories reported in Week 4 compared to run-in/screening week for the immediate intervention group and Week 8 compared to Week 4 for the delayed intervention group (i.e., within-group comparisons). | Run-in/screening week (immediate intervention arm), week 4 (both arms) and week 8 (delayed intervention arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes to Health and Work - Discrete Outcomes | The 6-item questionnaire will be used to assess the occurrence of any new traumatic events (presented below); any additional stressful life events (e.g. relationship problems, financial problems), new treatments received, social support received, changes to the job, or changes to the number of hours worked per week since the last assessment (see Supplementary Table 4 in Iyadurai et al., 2023). |
Inclusion criteria:
Exclusion criteria:
• Have fewer than three intrusive memories during the run-in week.
We will not exclude those undergoing other treatment for PTSD or its symptoms, so the study is as inclusive as possible to meet the challenges ICU staff are facing during the COVID-19 pandemic.
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| Name | Affiliation | Role |
|---|---|---|
| Emily Holmes | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P1vital Products Limited | Wallingford | Oxfordshire | OX10 8BA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37658043 | Background | Iyadurai L, Highfield J, Kanstrup M, Markham A, Ramineni V, Guo B, Jaki T, Kingslake J, Goodwin GM, Summers C, Bonsall MB, Holmes EA. Reducing intrusive memories after trauma via an imagery-competing task intervention in COVID-19 intensive care staff: a randomised controlled trial. Transl Psychiatry. 2023 Sep 1;13(1):290. doi: 10.1038/s41398-023-02578-0. | |
| 37100869 |
| Label | URL |
|---|---|
| Published paper of primary outcome results (Bayesian analysis) | View source |
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An anonymised database of individual participant data, along with a data dictionary, as well as the Clinical Study Report (which will include summarised anonymised participant data), will be shared on the Open Science Framework.
Study Protocol and Statistical Analysis Plan were made available on the Open Science Framework prior to LPLV. An executive summary of the Clinical Study Report was shared following publication. These together with supporting information (see below) are available indefinitely and with no end date on Open Science Framework Platform.
Anonymised research data will be made available on open science frame work (OSF) indefinitely.
OSF is an open source web application that is freely accessible to public and scientific community.
OSF links are:
Protocol, Optimisation SAP (Bayesian) and Descriptive SAP (Frequentist):
Bayesian paper analysis scripts, database and data code book:
Frequentist paper analysis scripts, database and data code book: https://osf.io/j9v2z/
106 Participants provided informed consent to participate. 4 participants did not meeting inclusion criteria after which 102 commenced run-in week intrusive memory diary.
88 participants were eligible after run-in week. 1 participant became lost to follow-up and 1 participant withdrew.
86 Participants were randomised (n=43 immediate arm; n=43 delayed arm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Intervention Arm | Immediate access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome). Brief digital imagery-competing task intervention: First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions. Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring). |
| FG001 | Delayed Intervention Arm | Usual care for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome), followed by access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks. Brief digital imagery-competing task intervention: First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions. Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring). |
| FG002 | Participants Who Commenced run-in Week But Were Not Randomised. | This study used a run-in week to establish a baseline number of intrusive memories over a seven-day period. Participants were randomised if they completed the run-in week and recorded at least three intrusive memories during the run-in week, and completed baseline questionnaires. As such, not all participants who commenced the run-in week completed baseline questionnaire and thus could not be randomised to either the immediate or delayed intervention arms. No data are available for those participants were not randomised. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Run-In/Screening Week |
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| Baseline Questionnaires |
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| Immediate Arm Receive Intervention |
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| Week 4 Primary Outcome |
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| Week 4 Secondary Outcomes |
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| Delayed Arm Receive Intervention |
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| Week 8 Replication After Crossover |
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| Week 8 - Other Secondary Outcomes |
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All participants randomised to an intervention condition (groups combined, n=86)
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Intervention Arm | Immediate access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome). Brief digital imagery-competing task intervention: First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions. Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring). |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Intrusive Memories of Traumatic Event(s) | Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days at week 4 (i.e., Day 22-28). To control for the number of intrusive memories recorded by participants in each experimental group during the run-in/screening week, we included the baseline count of intrusive memories (along with binary arm status) as fixed effect covariates in the Poisson regression model used for primary analysis. | All analyses were completed on an intention-to-treat basis as a between-group comparison. | Posted | Median | 95% Confidence Interval | Number of intrusive memories | Week 4 |
|
Adverse events were surveyed throughout the trial from enrolment to 8-weeks.
All participants were asked to report adverse events, including any additional stressful life events or regarding new treatments, with both passive (could be reported throughout the trial) and active surveillance (open ended questions at 4 and 8 weeks).
All adverse events and serious adverse events were unrelated to the study intervention or procedures.
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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 | Received Digital Imagery-Competing Task Intervention | Brief digital imagery-competing task intervention: First session guided by a researcher. Included a memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions. Thereafter, option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring). Immediate arm participants received access to the brief digital imagery-competing task intervention plus symptom monitoring for 8 weeks. Delayed arm participants received access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks (after 4 weeks of usual care). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest infection with reduced foetal movement | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Participant admitted to hospital: 'chest infection with reduced foetal movement'. No SAE or AE was related to the study intervention or procedures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Amy Beckenstrom | P1vital Products Ltd | +44(0)1865 522 030 | abeckenstrom@p1vital.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2022 | Nov 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 20, 2022 | Nov 29, 2023 | SAP_001.pdf |
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| OTHER |
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| Intrusive Memory Ratings, Ordinal Items | The 9-item questionnaire assesses a number of intrusive memories characteristics. These characteristics include frequency (7-point categorical response from 'never' to 'many times a day); distress (0=not at all to 10=extremely); disruption to concentration (0=not at all to 10=extremely); interference with what you were doing (how much (0=not at all to 10=extremely) and for how long (6-point categorical response from '<1min' to '+60mins')); impact on work functioning (0=not at all to 10=extremely) and in what ways (open text response)); impact on functioning in other areas of life (how much (0= not at all to 10 = extremely) and in what ways (open text response)). Five quantitative outcomes are presented here. For two further ordinal items, frequency and duration of interference, please see below. | Baseline, 4 weeks and 8 weeks |
| Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | The 9-item questionnaire assesses a number of intrusive memories characteristics. Five ordinal items are presented separately (see "Intrusive Memory Ratings, ordinal items"). Here we present one of the two categorical items. This item assesses the frequency of intrusive memories over the past week (7-point categorical response from 'never' to 'many times a day'). | Baseline, 4 weeks and 8 weeks |
| Intrusive Memory Ratings, Duration of Interference | The 9-item questionnaire assesses a number of intrusive memories characteristics. Five ordinal items are presented separately (see "Intrusive Memory Ratings, ordinal items"). Here we present one of the two categorical items. This item assesses the duration for which an intrusive memory interfered with with what participants were doing (6-point categorical response from '<1min' to '+60mins'). | Baseline, 4 weeks and 8 weeks |
| Impact of Event Scale-Revised (IES-R) | This 22-item questionnaire assesses subjective distress after a traumatic event (with reference to the events for which participants are taking part in the study). Items are rated for how distressing they have been during the past 7 days on a 5-point ordinal scale ranging from 0 ("not at all") to 4 ("extremely"). The measure consists of three subscales with subscale and total scores calculated as the mean of all items: intrusion subscale (8-items, score range 0-4), avoidance subscale (8-items, score range 0-4) and hyperarousal subscale (6-items, score range 0-4), and total score (all 22-items, score range 0-4). We will analyse total score as the mean of all 22-items, and subscales as the mean of items in each subscale separately. Higher scores indicate higher levels of subjective distress after a traumatic event. | Baseline, 4 weeks and 8 weeks |
| PTSD Checklist for DSM-5 (PCL-5) 4-item Version | This shortened 4-item version of the PCL-5 assesses symptoms of PTSD over the last month. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total score ranges from 0 to 16 (cut-off for possible PTSD is 10 or above). | Baseline, 4 weeks and 8 weeks |
| Sleep Condition Indicator (SCI) | This 8-item scale measures sleep problems against the DSM-5 criteria for insomnia disorder. Item responses are each scored 0-4, with scores from 0 to 2 indicating threshold criteria for insomnia disorder. Total score ranges 0-32, with a higher score indicating better sleep (cut-off for possible insomnia disorder is a total score from 0 to 2). | Baseline, 4 weeks and 8 weeks |
| Generalised Anxiety Disorder 2-item Scale (GAD-2) | Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible GAD is 3 or above). | Baseline, 4 weeks and 8 weeks |
| Patient Health Questionnaire 2-item Version (PHQ-2) | This 2-item short-form self-report measure assesses symptoms of depression. Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible major depressive disorder is 3 or above). | Baseline, 4 weeks and 8 weeks |
| Psychological Outcome Profiles (PSYCHLOPS) | This measure consists of 4 questions that are scored and designed to assess the impact of a person's intrusive memories. Questions 1b, 2b, 3b, and 4 are scored. These have a six-point ordinal scale ranging from 0 to 5 and are summed to generate a total score from 0 to 20. Higher values indicate the person is more severely affected. | Baseline, 4 weeks and 8 weeks |
| World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | The 12-item, self-report version of the WHODAS 2.0 will be used to assess difficulties in relation to the impact of intrusive memories. Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 (none) to 4 (extreme or cannot do). The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points). | Baseline, 4 weeks and 8 weeks |
| 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief measure for assessing general quality of life and health status. Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale. 5 items are scored on a 5-point ordinal scale from 'no problem' (1) to 'highest level of problems' (5). Respondents also self-rate their overall health today on a visual analogue scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Scores are analysed separately (not summed). Here we present the 'overall health' visual analogue scale item. | Baseline, 4 weeks and 8 weeks |
| Scale of Work Engagement and Burnout (SWEBO) | This 19-item self-report measure assesses work engagement and burnout. Respondents rate how often they have felt each descriptive item in the past two weeks, from 1 (not at all) to 4 (all the time). The work engagement subscale consists of 10-items assessing three dimensions (attentiveness, vigour, and dedication) with each dimension consisting of 4-, 3-, and 3-items respectively. Greater scores indicate a higher (i.e., better) degree of work engagement. The burnout subscale consists of 9-items assessing three dimensions (Engagement, Exhaustion, and Disengagement), with each dimension consisting of 3-items. Greater scores indicate a higher (i.e., functionally worse) degree of burnout. A mean score is calculated for the work engagement and burnout subscales, from individual items (for both subscales, scores range 1-4). | Time Frame: Baseline, 4 weeks and 8 weeks |
| Sickness Absence | Single item assessing self-reported number of sick days taken from work in the last 4 weeks. Total scoring includes total number of sick days. | Baseline, 4 weeks and 8 weeks |
| Intention to Leave Job | This 3 items questionnaire is used to assess participants' intention to leave their job e.g. "I think a lot about leaving the job", each rated from 1 (strongly agree) to 5 (strongly disagree). The total score ranges 3 to 15, with a lower score indicating stronger intention to leave the job. | Baseline, 4 weeks and 8 weeks |
| Weekly Work Pattern, Number of Days Worked | One item asses the number of days worked in the last week (both with responses from 0 to 7 days). | Baseline, 4 weeks and 8 weeks |
| Weekly Work Pattern, Number of Night Shifts Worked | One item asses the number of night shifts worked in the last week (both with responses from 0 to 7). | Baseline, 4 weeks and 8 weeks |
| 4 weeks and 8 weeks (both arms) |
| Changes to Health and Work - Continuous Outcomes | The 6-item questionnaire will be used to assess the occurrence of any new traumatic events (presented below); any additional stressful life events (e.g. relationship problems, financial problems), new treatments received, social support received, changes to the job, or changes to the number of hours worked per week since the last assessment (see Supplementary Table 4 in Iyadurai et al., 2023). | 4 weeks and 8 weeks (both arms) |
| Support From Managers and From Family/Friends | The 2 item questionnaire asks "During the COVID-19 pandemic, how well supported have you been by your supervisors/managers?" and "how well supported have you been by your family and friends?" The response is rated as "not at all", "quite a bit", "moderately", "quite a bit", or "extremely" | Baseline |
| Optimisation Assessment | Rates of recruitment, intervention use/adherence, outcome measure completion and participant attrition will be assessed. | Baseline, 4 weeks and 8 weeks |
| Feedback Questionnaire | This measure assesses participants' feedback for the intervention. Eight quantitative items assess how easy, helpful, distressing, burdensome and acceptable participants found the intervention, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within NHS ICUs, with each rated on a 11-point ordinal scale from 0 (not at all) to 10 (very). For all items, a higher score indicates greater acceptability for the intervention. The two items assessing distress and burden are reverse coded such that higher scores (e.g., 10) indicate lower distress and burden respectively. A total score of all eight ordinal items (range 0-80) is calculated as the sum of items. | Week 4 (immediate intervention arm), Week 8 (delayed intervention arm) |
| Optional Qualitative Interview | Qualitative interview will consist of a number of questions designed to gain an in-depth understanding of participants' experience of using the intervention, including acceptability, improvement suggestions, training/psychoeducation materials, potential barriers/facilitators to recruitment and uptake, and support needed for remote intervention delivery. | Week 5 (immediate intervention arm), Week 9 (delayed intervention arm) |
| Ramineni V, Millroth P, Iyadurai L, Jaki T, Kingslake J, Highfield J, Summers C, Bonsall MB, Holmes EA. Treating intrusive memories after trauma in healthcare workers: a Bayesian adaptive randomised trial developing an imagery-competing task intervention. Mol Psychiatry. 2023 Jul;28(7):2985-2994. doi: 10.1038/s41380-023-02062-7. Epub 2023 Apr 26. |
| Published paper of primary outcome results (Frequentist analysis) | View source |
| Withdrawal by Subject |
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Only participants in the Delayed Intervention Arm received their allocated intervention at this stage (after crossover). |
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| BG001 | Delayed Intervention Arm | Usual care for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome), followed by access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks. Brief digital imagery-competing task intervention: First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions. Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Total n observed for data is 84 (delayed arm n=42; immediate arm n=42) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Total n observed for data is 84 (delayed arm n=42; immediate arm n=42) | Count of Participants | Participants |
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| Marital Status | Total n observed for data is 84 (delayed arm n=42; immediate arm n=42) | Count of Participants | Participants |
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| Work and Employment, Number of hours worked per week | Total n observed for data is 84 (delayed arm n=42; immediate arm n=42) | Mean | Standard Deviation | Hours (per week) |
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| Work and Employment, Time as healthcare professional (years) | Total n observed for data is 84 (delayed arm n=42; immediate arm n=42) | Mean | Standard Deviation | Years |
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| Employment Status | Total n observed for data is 84 (delayed arm n=42; immediate arm n=42) | Count of Participants | Participants |
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| NHS Job Role | Count of Participants | Participants |
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| Health Background | Total n observed for data is 83 (delayed arm n=42; immediate arm n=41) | Count of Participants | Participants |
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| Experiences of Prior Trauma | Total n observed for data is 84 (delayed arm n=42; immediate arm n=42) | Mean | Standard Deviation | Number of events experienced/witnessed |
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| Types of Work-Related Traumatic Events Experienced | Total n observed for data is 84 (delayed arm n=42; immediate arm n=42). Note, categories below are not mutually exclusive as participants may have experienced multiple categories of potentially traumatic events. | Count of Participants | Participants |
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| Timeframe of work-related traumatic events experienced at baseline | Please note, outcome options are not necessarily mutually exclusive. | Count of Participants | Participants |
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| Perceived threat to self/other | Participants are asked to rate "to what extent did you feel your life was in danger?" and "to what extent did you think that someone else's life was in danger?" on a 10-point Likert scale from 0 (not at all) to 10 (extremely). This is based on the assessment of perceived life threat used in previous prospective studies following trauma (Blanchard et al., 1995), as used in Iyadurai et al. (2018). | Total n observed for data is 84 (delayed arm n=42; immediate arm n=41) | Mean | Standard Deviation | units on a 10-point Likert scale |
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| Peritraumatic Distress Inventory | This 13-item measure assesses the extent to which participants experienced a number of emotional reactions during the trauma (DSM-IV, criterion A2). Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and a total score is calculated as a sum of all 13-items (range 0-52). Higher scores indicate a higher level of distress. | Total n observed for data is 84 (delayed arm n=42; immediate arm n=41) | Mean | Standard Deviation | Total Score of Items |
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| OG001 | Delayed Intervention Arm | Usual care for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome), followed by access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks. Brief digital imagery-competing task intervention: First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions. Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring). |
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| Secondary | Number of Intrusive Memories of Traumatic Event(s) | Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days. Total number of intrusive memories reported in Week 4 compared to run-in/screening week for the immediate intervention group and Week 8 compared to Week 4 for the delayed intervention group (i.e., within-group comparisons). | Analyses were completed on an intention-to-treat basis. After crossover, a within-subjects comparison pre-post intervention (week 4 - week 8) was completed for the comparator delayed intervention group. Please see participant flow. | Posted | Median | Inter-Quartile Range | Number of intrusive memories | Run-in/screening week (immediate intervention arm), week 4 (both arms) and week 8 (delayed intervention arm) |
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| Secondary | Intrusive Memory Ratings, Ordinal Items | The 9-item questionnaire assesses a number of intrusive memories characteristics. These characteristics include frequency (7-point categorical response from 'never' to 'many times a day); distress (0=not at all to 10=extremely); disruption to concentration (0=not at all to 10=extremely); interference with what you were doing (how much (0=not at all to 10=extremely) and for how long (6-point categorical response from '<1min' to '+60mins')); impact on work functioning (0=not at all to 10=extremely) and in what ways (open text response)); impact on functioning in other areas of life (how much (0= not at all to 10 = extremely) and in what ways (open text response)). Five quantitative outcomes are presented here. For two further ordinal items, frequency and duration of interference, please see below. | Analyses were completed on an intention-to-treat basis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks and 8 weeks |
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| Secondary | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | The 9-item questionnaire assesses a number of intrusive memories characteristics. Five ordinal items are presented separately (see "Intrusive Memory Ratings, ordinal items"). Here we present one of the two categorical items. This item assesses the frequency of intrusive memories over the past week (7-point categorical response from 'never' to 'many times a day'). | Analyses were completed on an intention-to-treat basis. | Posted | Count of Participants | Participants | Baseline, 4 weeks and 8 weeks |
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| Secondary | Intrusive Memory Ratings, Duration of Interference | The 9-item questionnaire assesses a number of intrusive memories characteristics. Five ordinal items are presented separately (see "Intrusive Memory Ratings, ordinal items"). Here we present one of the two categorical items. This item assesses the duration for which an intrusive memory interfered with with what participants were doing (6-point categorical response from '<1min' to '+60mins'). | Analyses were completed on an intention-to-treat basis. | Posted | Count of Participants | Participants | Baseline, 4 weeks and 8 weeks |
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| Secondary | Impact of Event Scale-Revised (IES-R) | This 22-item questionnaire assesses subjective distress after a traumatic event (with reference to the events for which participants are taking part in the study). Items are rated for how distressing they have been during the past 7 days on a 5-point ordinal scale ranging from 0 ("not at all") to 4 ("extremely"). The measure consists of three subscales with subscale and total scores calculated as the mean of all items: intrusion subscale (8-items, score range 0-4), avoidance subscale (8-items, score range 0-4) and hyperarousal subscale (6-items, score range 0-4), and total score (all 22-items, score range 0-4). We will analyse total score as the mean of all 22-items, and subscales as the mean of items in each subscale separately. Higher scores indicate higher levels of subjective distress after a traumatic event. | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks and 8 weeks |
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| Secondary | PTSD Checklist for DSM-5 (PCL-5) 4-item Version | This shortened 4-item version of the PCL-5 assesses symptoms of PTSD over the last month. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total score ranges from 0 to 16 (cut-off for possible PTSD is 10 or above). | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Total score of 4-item scale measure | Baseline, 4 weeks and 8 weeks |
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| Secondary | Sleep Condition Indicator (SCI) | This 8-item scale measures sleep problems against the DSM-5 criteria for insomnia disorder. Item responses are each scored 0-4, with scores from 0 to 2 indicating threshold criteria for insomnia disorder. Total score ranges 0-32, with a higher score indicating better sleep (cut-off for possible insomnia disorder is a total score from 0 to 2). | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Total score of 8-item scale measure | Baseline, 4 weeks and 8 weeks |
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| Secondary | Generalised Anxiety Disorder 2-item Scale (GAD-2) | Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible GAD is 3 or above). | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Total score of 2-item scale measure | Baseline, 4 weeks and 8 weeks |
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| Secondary | Patient Health Questionnaire 2-item Version (PHQ-2) | This 2-item short-form self-report measure assesses symptoms of depression. Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible major depressive disorder is 3 or above). | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Total score of 2-item scale measure | Baseline, 4 weeks and 8 weeks |
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| Secondary | Psychological Outcome Profiles (PSYCHLOPS) | This measure consists of 4 questions that are scored and designed to assess the impact of a person's intrusive memories. Questions 1b, 2b, 3b, and 4 are scored. These have a six-point ordinal scale ranging from 0 to 5 and are summed to generate a total score from 0 to 20. Higher values indicate the person is more severely affected. | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Total score of 4-item scale measure | Baseline, 4 weeks and 8 weeks |
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| Secondary | World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | The 12-item, self-report version of the WHODAS 2.0 will be used to assess difficulties in relation to the impact of intrusive memories. Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 (none) to 4 (extreme or cannot do). The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points). | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Total score of 12-item scale measure | Baseline, 4 weeks and 8 weeks |
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| Secondary | 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief measure for assessing general quality of life and health status. Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale. 5 items are scored on a 5-point ordinal scale from 'no problem' (1) to 'highest level of problems' (5). Respondents also self-rate their overall health today on a visual analogue scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Scores are analysed separately (not summed). Here we present the 'overall health' visual analogue scale item. | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks and 8 weeks |
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| Secondary | Scale of Work Engagement and Burnout (SWEBO) | This 19-item self-report measure assesses work engagement and burnout. Respondents rate how often they have felt each descriptive item in the past two weeks, from 1 (not at all) to 4 (all the time). The work engagement subscale consists of 10-items assessing three dimensions (attentiveness, vigour, and dedication) with each dimension consisting of 4-, 3-, and 3-items respectively. Greater scores indicate a higher (i.e., better) degree of work engagement. The burnout subscale consists of 9-items assessing three dimensions (Engagement, Exhaustion, and Disengagement), with each dimension consisting of 3-items. Greater scores indicate a higher (i.e., functionally worse) degree of burnout. A mean score is calculated for the work engagement and burnout subscales, from individual items (for both subscales, scores range 1-4). | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | score on a scale | Time Frame: Baseline, 4 weeks and 8 weeks |
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| Secondary | Sickness Absence | Single item assessing self-reported number of sick days taken from work in the last 4 weeks. Total scoring includes total number of sick days. | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Number of sick days | Baseline, 4 weeks and 8 weeks |
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| Secondary | Intention to Leave Job | This 3 items questionnaire is used to assess participants' intention to leave their job e.g. "I think a lot about leaving the job", each rated from 1 (strongly agree) to 5 (strongly disagree). The total score ranges 3 to 15, with a lower score indicating stronger intention to leave the job. | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Total score of 3-item scale measure | Baseline, 4 weeks and 8 weeks |
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| Secondary | Weekly Work Pattern, Number of Days Worked | One item asses the number of days worked in the last week (both with responses from 0 to 7 days). | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Days worked | Baseline, 4 weeks and 8 weeks |
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| Secondary | Weekly Work Pattern, Number of Night Shifts Worked | One item asses the number of night shifts worked in the last week (both with responses from 0 to 7). | Analyses were completed on an intention-to-treat basis. | Posted | Mean | Standard Deviation | Nights worked | Baseline, 4 weeks and 8 weeks |
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| Other Pre-specified | Changes to Health and Work - Discrete Outcomes | The 6-item questionnaire will be used to assess the occurrence of any new traumatic events (presented below); any additional stressful life events (e.g. relationship problems, financial problems), new treatments received, social support received, changes to the job, or changes to the number of hours worked per week since the last assessment (see Supplementary Table 4 in Iyadurai et al., 2023). | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Count of Participants | Participants | 4 weeks and 8 weeks (both arms) |
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| Other Pre-specified | Changes to Health and Work - Continuous Outcomes | The 6-item questionnaire will be used to assess the occurrence of any new traumatic events (presented below); any additional stressful life events (e.g. relationship problems, financial problems), new treatments received, social support received, changes to the job, or changes to the number of hours worked per week since the last assessment (see Supplementary Table 4 in Iyadurai et al., 2023). | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Mean | Standard Deviation | Number of events experienced/witnessed | 4 weeks and 8 weeks (both arms) |
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| Other Pre-specified | Support From Managers and From Family/Friends | The 2 item questionnaire asks "During the COVID-19 pandemic, how well supported have you been by your supervisors/managers?" and "how well supported have you been by your family and friends?" The response is rated as "not at all", "quite a bit", "moderately", "quite a bit", or "extremely" | Analyses were completed on an intention-to-treat basis. Please see Participant Flow. | Posted | Count of Participants | Participants | Baseline |
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| Other Pre-specified | Optimisation Assessment | Rates of recruitment, intervention use/adherence, outcome measure completion and participant attrition will be assessed. | Not Posted | Baseline, 4 weeks and 8 weeks | Participants |
| Other Pre-specified | Feedback Questionnaire | This measure assesses participants' feedback for the intervention. Eight quantitative items assess how easy, helpful, distressing, burdensome and acceptable participants found the intervention, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within NHS ICUs, with each rated on a 11-point ordinal scale from 0 (not at all) to 10 (very). For all items, a higher score indicates greater acceptability for the intervention. The two items assessing distress and burden are reverse coded such that higher scores (e.g., 10) indicate lower distress and burden respectively. A total score of all eight ordinal items (range 0-80) is calculated as the sum of items. | Posted | Mean | Standard Deviation | Total summed score of 8-items | Week 4 (immediate intervention arm), Week 8 (delayed intervention arm) |
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| Other Pre-specified | Optional Qualitative Interview | Qualitative interview will consist of a number of questions designed to gain an in-depth understanding of participants' experience of using the intervention, including acceptability, improvement suggestions, training/psychoeducation materials, potential barriers/facilitators to recruitment and uptake, and support needed for remote intervention delivery. | Not Posted | Week 5 (immediate intervention arm), Week 9 (delayed intervention arm) | Participants |
| 0 |
| 78 |
| 1 |
| 78 |
| 4 |
| 78 |
| EG001 | Usual Care (i.e., Delayed Arm, Randomisation - Week 4) | Delayed arm participants could continue to access usual care for 4 weeks from randomisation. After 4-weeks, participants then received access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks. | 0 | 43 | 0 | 43 | 2 | 43 |
| EG002 | Run-In Period | At baseline, participants completed a daily online intrusive memory diary for 7 days to record the number of intrusive memories to work-related traumatic events. Those who reported at least 3 intrusive memories during the baseline week were asked to complete questionnaires and were randomised. The total number of intrusive memories that each participant recorded was included as a baseline covariate in the statistical modelling. | 0 | 102 | 0 | 102 | 0 | 102 |
|
Not provided
Not provided
Not provided
| Other (Transwoman; Transman; Gender-variant/non-binary; Other Identity; Prefer not to answer) |
|
| White - Any other White background |
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| Mixed - Any other mixed background |
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| Asian - Indian |
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| Asian - Any other Asian background |
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| Black - African |
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| Other - Any other ethnic group |
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| Unknown - Not stated |
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| Other categories (see publication for specification of other categories) |
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| Married or cohabiting |
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| Divorced or separated |
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| Other categories (Widowed; Other) |
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| Sick leave |
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| Other |
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| Other categories (Jobseeking; Student; Retired) |
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| Health Informatics |
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| Healthcare Support Worker |
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| Nursing |
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| Other/unknown |
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| Pharmacy |
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| No |
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| No |
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| No |
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| Week 4 |
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| Week 8 (Delayed Arm Only) |
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| Superiority |
Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the delayed intervention arm, comparing pre-intervention (week 4) to post-intervention (week 8). |
For full results see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0 |
| Within the immediate intervention arm, where participants had immediate access to the intervention, the number of intrusive memories in Week 4 was compared to the run-in/screening week. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0 | Regression, Poisson | Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention. | <0.001 | No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05. | Incidence Rate Ratio | 0.22 | 2-Sided | 95 | 0.10 | 0.45 | Superiority | Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the immediate intervention arm, comparing pre-intervention (run-in/screening week) to post-intervention (week 4). |
| Week 4 - How distressing were your intrusive memories? |
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| Week 8- How distressing were your intrusive memories? |
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| Baseline - How much did they disrupt your concentration? |
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| Week 4 - How much did they disrupt your concentration? |
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| Week 8 - How much did they disrupt your concentration? |
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| Baseline - How much did they interfere with what you were doing? |
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| Week 4 - How much did they interfere with what you were doing? |
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| Week 8 - How much did they interfere with what you were doing? |
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| Baseline - How much did your intrusive memories affect your work functioning? |
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| Week 4 - How much did your intrusive memories affect your work functioning? |
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| Week 8 - How much did your intrusive memories affect your work functioning? |
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| Baseline - How much did your intrusive memories affect your functioning in other areas of your life? |
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| Week 4 - How much did your intrusive memories affect your functioning in other areas of your life? |
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| Week 8 - How much did your intrusive memories affect your functioning in other areas of your life? |
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Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures. |
Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| ITT analysis for Intrusive memory ratings, 'How much did they disrupt your concentration?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0 | Regression, Multilevel Linear | <= 0.001 | No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -3.21 | 2-Sided | 95 | -4.28 | -2.15 | Superiority | Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures. | Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| ITT analysis for Intrusive memory ratings, 'How much did they interfere with what you were doing?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0 | Regression, Multilevel Linear | <= 0.001 | No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -2.92 | 2-Sided | 95 | -3.90 | -1.95 | Superiority | Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures. | Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your work functioning?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0 | Regression, Multilevel Linear | <= 0.001 | No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -2.15 | 2-Sided | 95 | -3.22 | -1.08 | Superiority | Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures. | Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your functioning in other areas of your life?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0 | Regression, Multilevel Linear | <= 0.001 | No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -2.59 | 2-Sided | 95 | -3.67 | -1.51 | Superiority | Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures. | Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Once |
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| Twice |
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| Every other day |
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| Once a day |
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| Several times a day |
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| Many times a day |
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| Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? |
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| Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? |
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| 1-5mins |
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| 6-10mins |
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| 11-30mins |
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| 31-60mins |
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| +60mins |
|
| Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? |
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| Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? |
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| Week 4 - Total Score |
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| Week 8 - Total Score |
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| Baseline - Intrusion Subscale |
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| Week 4 - Intrusion Subscale |
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| Week 8 - Intrusion Subscale |
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| Baseline - Avoidance Subscale |
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| Week 4 - Avoidance Subscale |
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| Week 8 - Avoidance Subscale |
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| Baseline - Hyperarousal Subscale |
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| Week 4 - Hyperarousal Subscale |
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| Week 8 - Hyperarousal Subscale |
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Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| ITT analysis for Impact of Event Scale-Revised Intrusion Subscale (treatment effects for between-arm comparisons) at week 4. | Regression, Multilevel Linear | <= 0.001 | No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -0.95 | 2-Sided | 95 | -1.27 | -0.62 | Superiority | Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures. | Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| ITT analysis for Impact of Event Scale-Revised Avoidance Subscale (treatment effects for between-arm comparisons) at week 4. | Regression, Multilevel Linear | <= 0.001 | No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -0.75 | 2-Sided | 95 | -1.09 | -0.42 | Superiority | Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures. | Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| ITT analysis for Impact of Event Scale-Revised Hyperarousal Subscale (treatment effects for between-arm comparisons) at week 4. | Regression, Multilevel Linear | <= 0.001 | No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -0.70 | 2-Sided | 95 | -0.97 | -0.44 | Superiority | Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures. | Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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|
Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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|
Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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Please see Iyadurai et al., 2023 for EQ-5D-5L subscale comparisons and Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 - Work Engagement Subscale |
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| Week 8 - Work Engagement Subscale |
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| Baseline - Burnout Subscale |
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| Week 4 - Burnout Subscale |
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| Week 8 - Burnout Subscale |
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Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Subscale (treatment effects for between-arm comparisons) at week 4. | Regression, Multilevel Linear | <= 0.001 | No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05. | Mean Difference (Final Values) | -0.61 | 2-Sided | 95 | -0.87 | -0.34 | Superiority | Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures. | Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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|
Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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|
Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 - On how many days did you work this week? |
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| Week 8 - On how many days did you work this week? |
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|
Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| Week 4 |
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| Week 8 |
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|
Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0) |
| No |
|
| Week 8 -Have you experienced or witnessed any new work-related traumatic events? |
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| Week 8 - How many new work-related traumatic events have you experienced/witnessed? |
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| Week 4 - How many new traumatic events that were not work-related have you experienced/witnessed? |
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| Week 8 - How many new traumatic events that were not work-related have you experienced/witnessed? |
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| Moderately |
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| Quite a bit |
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| Extremely |
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| How well supported have you been by your family & friends? |
|