Intrusive Memories of Traumatic Event(s)
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALBrief 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).
Sponsors
Wellcome Trust
Uppsala University
Intensive Care Society
University of Nottingham
P1vital Products Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 or above. * Able to read, write and speak in English. * Worked in a clinical role in an NHS Intensive Care Unit or equivalent during the COVID-19 pandemic (e.g. as a member of ICU staff or deployed to work in the ICU during the pandemic) * Experienced at least one traumatic event related to their work during the COVID-19 pandemic, meeting criterion A of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for Post-Traumatic Stress Disorder (PTSD): exposure to actual or threatened death, serious injury, or sexual violence by directly experiencing the traumatic event(s) or witnessing, in person, the event(s) as it occurred to others * Experience intrusive memories of the traumatic event(s). * Experienced at least three intrusive memories in the week prior to screening. * Have internet access. * Willing and able to provide informed consent and complete study procedures (including briefly listing their intrusive memories (without going into any detail), and playing the brief digital imagery-competing task with particular mental rotation instructions, and completing an online intrusive memory diary). * Willing and able to be contacted by the research team during the study period.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Intrusive Memories of Traumatic Event(s) | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Condition Indicator (SCI) | Baseline, 4 weeks and 8 weeks | 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). |
| 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | Baseline, 4 weeks and 8 weeks | 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. |
| Scale of Work Engagement and Burnout (SWEBO) | Time Frame: Baseline, 4 weeks and 8 weeks | 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). |
| Sickness Absence | Baseline, 4 weeks and 8 weeks | 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. |
| Intention to Leave Job | Baseline, 4 weeks and 8 weeks | 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. |
| Weekly Work Pattern, Number of Days Worked | Baseline, 4 weeks and 8 weeks | One item asses the number of days worked in the last week (both with responses from 0 to 7 days). |
| Weekly Work Pattern, Number of Night Shifts Worked | Baseline, 4 weeks and 8 weeks | One item asses the number of night shifts worked in the last week (both with responses from 0 to 7). |
| Number of Intrusive Memories of Traumatic Event(s) | Run-in/screening week (immediate intervention arm), week 4 (both arms) and week 8 (delayed intervention arm) | 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). |
| Intrusive Memory Ratings, Ordinal Items | Baseline, 4 weeks and 8 weeks | 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. |
| Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline, 4 weeks and 8 weeks | 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'). |
| Intrusive Memory Ratings, Duration of Interference | Baseline, 4 weeks and 8 weeks | 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'). |
| Impact of Event Scale-Revised (IES-R) | Baseline, 4 weeks and 8 weeks | 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. |
| PTSD Checklist for DSM-5 (PCL-5) 4-item Version | Baseline, 4 weeks and 8 weeks | 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). |
| Generalised Anxiety Disorder 2-item Scale (GAD-2) | Baseline, 4 weeks and 8 weeks | 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). |
| Patient Health Questionnaire 2-item Version (PHQ-2) | Baseline, 4 weeks and 8 weeks | 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). |
| Psychological Outcome Profiles (PSYCHLOPS) | Baseline, 4 weeks and 8 weeks | 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. |
| World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | Baseline, 4 weeks and 8 weeks | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Support From Managers and From Family/Friends | Baseline | 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 |
| Optimisation Assessment | Baseline, 4 weeks and 8 weeks | Rates of recruitment, intervention use/adherence, outcome measure completion and participant attrition will be assessed. |
| Feedback Questionnaire | Week 4 (immediate intervention arm), Week 8 (delayed intervention arm) | 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. |
| Optional Qualitative Interview | Week 5 (immediate intervention arm), Week 9 (delayed intervention arm) | 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. |
| Changes to Health and Work - Discrete Outcomes | 4 weeks and 8 weeks (both arms) | 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). |
| Changes to Health and Work - Continuous Outcomes | 4 weeks and 8 weeks (both arms) | 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). |
Countries
United Kingdom
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 43 |
| 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). | 43 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Baseline Questionnaires | Lost to Follow-up | 0 | 0 | 1 |
| Baseline Questionnaires | Withdrawal by Subject | 0 | 0 | 1 |
| Delayed Arm Receive Intervention | Withdrawal by Subject | 0 | 1 | 0 |
| Run-In/Screening Week | Lost to Follow-up | 0 | 0 | 6 |
| Run-In/Screening Week | Recorded fewer than three intrusive memories | 0 | 0 | 7 |
| Run-In/Screening Week | Withdrawal by Subject | 0 | 0 | 1 |
| Week 4 Primary Outcome | Did not complete week 4 diary but not lost to follow-up | 1 | 0 | 0 |
| Week 4 Primary Outcome | Lost to Follow-up | 3 | 2 | 0 |
| Week 4 Primary Outcome | Withdrawal by Subject | 0 | 2 | 0 |
| Week 4 Secondary Outcomes | Lost to Follow-up | 3 | 0 | 0 |
| Week 4 Secondary Outcomes | Secondary questionnaires missing/partially complete | 5 | 1 | 0 |
| Week 4 Secondary Outcomes | Withdrawal by Subject | 1 | 0 | 0 |
| Week 8 - Other Secondary Outcomes | Lost to Follow-up | 2 | 0 | 0 |
| Week 8 - Other Secondary Outcomes | Secondary questionnaires partially complete | 0 | 3 | 0 |
| Week 8 Replication After Crossover | Lost to Follow-up | 0 | 4 | 0 |
| Week 8 Replication After Crossover | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Immediate Intervention Arm | Delayed Intervention Arm | Total |
|---|---|---|---|
| Age, Continuous | 37.4 years STANDARD_DEVIATION 9.8 | 39.9 years STANDARD_DEVIATION 9.9 | 38.7 years STANDARD_DEVIATION 9.9 |
| Employment Status Other | 1 Participants | 0 Participants | 1 Participants |
| Employment Status Other categories (Jobseeking; Student; Retired) | 0 Participants | 0 Participants | 0 Participants |
| Employment Status Sick leave | 1 Participants | 0 Participants | 1 Participants |
| Employment Status Working full time | 34 Participants | 32 Participants | 66 Participants |
| Employment Status Working part time | 6 Participants | 10 Participants | 16 Participants |
| Experiences of Prior Trauma How many traumatic events that were not work-related have you experienced/witnessed during COVID-19? | 4.5 Number of events experienced/witnessed STANDARD_DEVIATION 15.6 | 10.2 Number of events experienced/witnessed STANDARD_DEVIATION 46.2 | 7.3 Number of events experienced/witnessed STANDARD_DEVIATION 34.4 |
| Experiences of Prior Trauma How many work-related traumatic events have you experienced/witnessed during COVID-19? | 35.9 Number of events experienced/witnessed STANDARD_DEVIATION 58 | 38.4 Number of events experienced/witnessed STANDARD_DEVIATION 80.9 | 37.1 Number of events experienced/witnessed STANDARD_DEVIATION 70 |
| Health Background Are you receiving any current treatments/medications for these? No | 26 Participants | 25 Participants | 51 Participants |
| Health Background Are you receiving any current treatments/medications for these? Yes | 15 Participants | 17 Participants | 32 Participants |
| Health Background Do you have any current physical health problems e.g. diabetes, heart problems? No | 33 Participants | 33 Participants | 66 Participants |
| Health Background Do you have any current physical health problems e.g. diabetes, heart problems? Yes | 8 Participants | 9 Participants | 17 Participants |
| Health Background Has anyone in your close family been treated for/diagnosed with any mental health problems? No | 27 Participants | 26 Participants | 53 Participants |
| Health Background Has anyone in your close family been treated for/diagnosed with any mental health problems? Yes | 14 Participants | 16 Participants | 30 Participants |
| Health Background Have you been treated for/diagnosed with any mental health problems e.g. depression, anxiety, PTSD? No | 19 Participants | 18 Participants | 37 Participants |
| Health Background Have you been treated for/diagnosed with any mental health problems e.g. depression, anxiety, PTSD? Yes | 22 Participants | 24 Participants | 46 Participants |
| Marital Status Divorced or separated | 3 Participants | 1 Participants | 4 Participants |
| Marital Status Living apart from partner | 1 Participants | 0 Participants | 1 Participants |
| Marital Status Married or cohabiting | 25 Participants | 28 Participants | 53 Participants |
| Marital Status Other categories (Widowed; Other) | 0 Participants | 0 Participants | 0 Participants |
| Marital Status Single | 13 Participants | 13 Participants | 26 Participants |
| NHS Job Role Allied Health Professionals | 3 Participants | 1 Participants | 4 Participants |
| NHS Job Role Doctors | 8 Participants | 11 Participants | 19 Participants |
| NHS Job Role Healthcare Support Worker | 2 Participants | 1 Participants | 3 Participants |
| NHS Job Role Health Informatics | 0 Participants | 1 Participants | 1 Participants |
| NHS Job Role Nursing | 29 Participants | 28 Participants | 57 Participants |
| NHS Job Role Other/unknown | 0 Participants | 1 Participants | 1 Participants |
| NHS Job Role Pharmacy | 1 Participants | 0 Participants | 1 Participants |
| Perceived threat to self/other Perceived life threat to self | 4.7 units on a 10-point Likert scale STANDARD_DEVIATION 3.4 | 5.3 units on a 10-point Likert scale STANDARD_DEVIATION 3.4 | 5.0 units on a 10-point Likert scale STANDARD_DEVIATION 3.4 |
| Perceived threat to self/other Perceived life threat to someone else | 9.1 units on a 10-point Likert scale STANDARD_DEVIATION 1.4 | 8.3 units on a 10-point Likert scale STANDARD_DEVIATION 2.8 | 8.7 units on a 10-point Likert scale STANDARD_DEVIATION 2.3 |
| Peritraumatic Distress Inventory | 30.5 Total Score of Items STANDARD_DEVIATION 10.2 | 28.6 Total Score of Items STANDARD_DEVIATION 9.9 | 29.6 Total Score of Items STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized Ethnicity Asian - Any other Asian background | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Asian - Indian | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Black - African | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed - Any other mixed background | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Other - Any other ethnic group | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Other categories (see publication for specification of other categories) | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown - Not stated | 8 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Ethnicity White - Any other White background | 9 Participants | 14 Participants | 23 Participants |
| Race/Ethnicity, Customized Ethnicity White - British | 18 Participants | 18 Participants | 36 Participants |
| Race/Ethnicity, Customized Ethnicity White - Irish | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Gender Man | 8 Participants | 7 Participants | 15 Participants |
| Sex/Gender, Customized Gender Other (Transwoman; Transman; Gender-variant/non-binary; Other Identity; Prefer not to answer) | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Gender Woman | 34 Participants | 35 Participants | 69 Participants |
| Timeframe of work-related traumatic events experienced at baseline Between 1-3 months ago | 8 Participants | 7 Participants | 15 Participants |
| Timeframe of work-related traumatic events experienced at baseline More than 3 months ago | 22 Participants | 24 Participants | 46 Participants |
| Timeframe of work-related traumatic events experienced at baseline Ongoing exposure to traumatic events is part of my job during the COVID-19 pandemic | 33 Participants | 37 Participants | 70 Participants |
| Timeframe of work-related traumatic events experienced at baseline Within the last 24 hours | 3 Participants | 4 Participants | 7 Participants |
| Timeframe of work-related traumatic events experienced at baseline Within the past month | 7 Participants | 8 Participants | 15 Participants |
| Types of Work-Related Traumatic Events Experienced A severe or unsuccessful resuscitation | 26 Participants | 32 Participants | 58 Participants |
| Types of Work-Related Traumatic Events Experienced A traumatic or tragic death of a patient | 38 Participants | 40 Participants | 78 Participants |
| Types of Work-Related Traumatic Events Experienced A traumatic or tragic event where a patient reminded you of yourself, a family member or friend | 29 Participants | 31 Participants | 60 Participants |
| Types of Work-Related Traumatic Events Experienced Being faced with suicide / suicide attempt | 14 Participants | 18 Participants | 32 Participants |
| Types of Work-Related Traumatic Events Experienced Event involving extremely distressed/grieving relatives of patients | 37 Participants | 33 Participants | 70 Participants |
| Types of Work-Related Traumatic Events Experienced Event involving sudden increased risk of COVID-19 infection | 23 Participants | 29 Participants | 52 Participants |
| Types of Work-Related Traumatic Events Experienced Other | 5 Participants | 2 Participants | 7 Participants |
| Types of Work-Related Traumatic Events Experienced Situation where the care of a patient failed or did not go as planned | 33 Participants | 31 Participants | 64 Participants |
| Types of Work-Related Traumatic Events Experienced Threats or violence against healthcare professionals | 26 Participants | 13 Participants | 39 Participants |
| Types of Work-Related Traumatic Events Experienced Witnessing events surrounding colleague who has fallen ill or died of COVID-19 | 19 Participants | 18 Participants | 37 Participants |
| Work and Employment, Number of hours worked per week | 37.9 Hours (per week) STANDARD_DEVIATION 13.3 | 37.8 Hours (per week) STANDARD_DEVIATION 9.2 | 37.8 Hours (per week) STANDARD_DEVIATION 11.4 |
| Work and Employment, Time as healthcare professional (years) | 13.0 Years STANDARD_DEVIATION 8.6 | 16.4 Years STANDARD_DEVIATION 10.8 | 14.7 Years STANDARD_DEVIATION 9.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 43 | 0 / 102 |
| other Total, other adverse events | 4 / 78 | 2 / 43 | 0 / 102 |
| serious Total, serious adverse events | 1 / 78 | 0 / 43 | 0 / 102 |
Outcome results
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.
Time frame: Week 4
Population: All analyses were completed on an intention-to-treat basis as a between-group comparison.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Immediate Intervention Arm | Number of Intrusive Memories of Traumatic Event(s) | Run-in/screening week | 14.5 Number of intrusive memories |
| Immediate Intervention Arm | Number of Intrusive Memories of Traumatic Event(s) | Week 4 (Primary Outcome) | 1.0 Number of intrusive memories |
| Delayed Intervention Arm | Number of Intrusive Memories of Traumatic Event(s) | Run-in/screening week | 14.0 Number of intrusive memories |
| Delayed Intervention Arm | Number of Intrusive Memories of Traumatic Event(s) | Week 4 (Primary Outcome) | 10.0 Number of intrusive memories |
Comparison: For more information on analysis models see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0p-value: <=0.00195% CI: [0.2, 0.48]Regression, Poisson
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.
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | Baseline | 66.03 units on a scale | Standard Deviation 19.4 |
| Immediate Intervention Arm | 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | Week 4 | 78.68 units on a scale | Standard Deviation 13.52 |
| Immediate Intervention Arm | 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | Week 8 | 76.29 units on a scale | Standard Deviation 14.83 |
| Delayed Intervention Arm | 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | Baseline | 67.83 units on a scale | Standard Deviation 19.3 |
| Delayed Intervention Arm | 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | Week 4 | 65.13 units on a scale | Standard Deviation 21.51 |
| Delayed Intervention Arm | 5-level European Quality of Life 5 Dimension (EQ-5D-5L) | Week 8 | 78.23 units on a scale | Standard Deviation 18.17 |
Comparison: ITT analysis for 5-level European Quality of Life 5 Dimension (EQ-5D-5L) (treatment effects for between-arm comparisons) at week 4.p-value: <=0.0195% CI: [4.61, 20.04]Regression, Multilevel Linear
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).
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Generalised Anxiety Disorder 2-item Scale (GAD-2) | Baseline | 3.83 Total score of 2-item scale measure | Standard Deviation 1.8 |
| Immediate Intervention Arm | Generalised Anxiety Disorder 2-item Scale (GAD-2) | Week 4 | 2.07 Total score of 2-item scale measure | Standard Deviation 1.91 |
| Immediate Intervention Arm | Generalised Anxiety Disorder 2-item Scale (GAD-2) | Week 8 | 1.65 Total score of 2-item scale measure | Standard Deviation 1.98 |
| Delayed Intervention Arm | Generalised Anxiety Disorder 2-item Scale (GAD-2) | Baseline | 3.07 Total score of 2-item scale measure | Standard Deviation 1.81 |
| Delayed Intervention Arm | Generalised Anxiety Disorder 2-item Scale (GAD-2) | Week 4 | 2.84 Total score of 2-item scale measure | Standard Deviation 1.79 |
| Delayed Intervention Arm | Generalised Anxiety Disorder 2-item Scale (GAD-2) | Week 8 | 1.29 Total score of 2-item scale measure | Standard Deviation 1.55 |
Comparison: ITT analysis for Generalised Anxiety Disorder 2-item scale (GAD-2) (treatment effects for between-arm comparisons) at week 4.p-value: <=0.0595% CI: [-1.68, -0.17]Regression, Multilevel Linear
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.
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Baseline - Avoidance Subscale | 2.22 score on a scale | Standard Deviation 0.83 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 8 - Total Score | 0.78 score on a scale | Standard Deviation 0.66 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 4 - Avoidance Subscale | 1.95 score on a scale | Standard Deviation 0.7 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 8 - Intrusion Subscale | 0.85 score on a scale | Standard Deviation 0.71 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 8 - Avoidance Subscale | 0.87 score on a scale | Standard Deviation 0.83 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Baseline - Intrusion Subscale | 2.43 score on a scale | Standard Deviation 0.8 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Baseline - Hyperarousal Subscale | 1.83 score on a scale | Standard Deviation 0.93 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 4 - Total Score | 1.70 score on a scale | Standard Deviation 0.56 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 4 - Hyperarousal Subscale | 1.27 score on a scale | Standard Deviation 0.68 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 4 - Intrusion Subscale | 1.86 score on a scale | Standard Deviation 0.67 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 8 - Hyperarousal Subscale | 0.60 score on a scale | Standard Deviation 0.63 |
| Immediate Intervention Arm | Impact of Event Scale-Revised (IES-R) | Baseline - Total Score | 2.17 score on a scale | Standard Deviation 0.71 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 8 - Hyperarousal Subscale | 0.41 score on a scale | Standard Deviation 0.55 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Baseline - Total Score | 2.24 score on a scale | Standard Deviation 0.77 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 4 - Total Score | 0.83 score on a scale | Standard Deviation 0.58 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 8 - Total Score | 0.58 score on a scale | Standard Deviation 0.59 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Baseline - Intrusion Subscale | 2.52 score on a scale | Standard Deviation 0.91 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 4 - Intrusion Subscale | 0.87 score on a scale | Standard Deviation 0.63 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Baseline - Avoidance Subscale | 2.19 score on a scale | Standard Deviation 0.81 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 4 - Avoidance Subscale | 1.06 score on a scale | Standard Deviation 0.75 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 8 - Avoidance Subscale | 0.68 score on a scale | Standard Deviation 0.76 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Baseline - Hyperarousal Subscale | 2.03 score on a scale | Standard Deviation 0.96 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 4 - Hyperarousal Subscale | 0.53 score on a scale | Standard Deviation 0.52 |
| Delayed Intervention Arm | Impact of Event Scale-Revised (IES-R) | Week 8 - Intrusion Subscale | 0.62 score on a scale | Standard Deviation 0.62 |
Comparison: ITT analysis for Impact of Event Scale-Revised Avoidance Subscale (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [-1.09, -0.42]Regression, Multilevel Linear
Comparison: ITT analysis for Impact of Event Scale-Revised Total Score (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [-1.08, -0.53]Regression, Multilevel Linear
Comparison: ITT analysis for Impact of Event Scale-Revised Intrusion Subscale (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [-1.27, -0.62]Regression, Multilevel Linear
Comparison: ITT analysis for Impact of Event Scale-Revised Hyperarousal Subscale (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [-0.97, -0.44]Regression, Multilevel Linear
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.
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Intention to Leave Job | Baseline | 8.65 Total score of 3-item scale measure | Standard Deviation 3.79 |
| Immediate Intervention Arm | Intention to Leave Job | Week 4 | 9.36 Total score of 3-item scale measure | Standard Deviation 4.63 |
| Immediate Intervention Arm | Intention to Leave Job | Week 8 | 9.94 Total score of 3-item scale measure | Standard Deviation 4.62 |
| Delayed Intervention Arm | Intention to Leave Job | Baseline | 9.19 Total score of 3-item scale measure | Standard Deviation 3.62 |
| Delayed Intervention Arm | Intention to Leave Job | Week 4 | 10.32 Total score of 3-item scale measure | Standard Deviation 3.35 |
| Delayed Intervention Arm | Intention to Leave Job | Week 8 | 10.26 Total score of 3-item scale measure | Standard Deviation 3.86 |
Comparison: ITT analysis for Intention to leave job (treatment effects for between-arm comparisons) at week 4.p-value: >0.0595% CI: [-2.2, 0.49]Regression, Multilevel Linear
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').
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | <1min | 17 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | 1-5mins | 21 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | 6-10mins | 3 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | 11-30mins | 1 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | 31-60mins | 1 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | +60mins | 0 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | <1min | 15 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | 1-5mins | 19 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | 6-10mins | 3 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | 11-30mins | 1 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | 31-60mins | 0 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | +60mins | 0 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | <1min | 23 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | 1-5mins | 4 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | 6-10mins | 2 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | 11-30mins | 1 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | 31-60mins | 0 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | +60mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | 1-5mins | 4 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | <1min | 16 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | 11-30mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | 1-5mins | 17 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | +60mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | 6-10mins | 9 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | 31-60mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | 11-30mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | 6-10mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | 31-60mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | +60mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Baseline - Each time, for (approximately) how long did they interfere with what you were doing? | +60mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | 31-60mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | <1min | 27 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | <1min | 27 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | 1-5mins | 8 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 8 - Each time, for (approximately) how long did they interfere with what you were doing? | 11-30mins | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Duration of Interference | Week 4 - Each time, for (approximately) how long did they interfere with what you were doing? | 6-10mins | 0 Participants |
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').
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Never | 0 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once | 0 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Twice | 1 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Every other day | 14 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once a day | 7 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Several times a day | 18 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Many times a day | 3 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Never | 0 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once | 1 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Twice | 2 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Every other day | 10 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once a day | 7 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Several times a day | 15 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Many times a day | 3 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Never | 7 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once | 12 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Twice | 3 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Every other day | 4 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once a day | 1 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Several times a day | 2 Participants |
| Immediate Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Many times a day | 1 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Every other day | 6 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Never | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once a day | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once | 1 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once a day | 4 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Twice | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Twice | 7 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Every other day | 6 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Several times a day | 2 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once a day | 6 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Many times a day | 0 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Several times a day | 28 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Many times a day | 1 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Baseline - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Many times a day | 1 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Every other day | 5 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Never | 11 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Never | 14 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once | 6 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Several times a day | 2 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 4 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Twice | 5 Participants |
| Delayed Intervention Arm | Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week | Week 8 - Approximately how often did intrusive memories of the traumatic event pop into your mind? | Once | 3 Participants |
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.
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How much did they disrupt your concentration? | 5.95 score on a scale | Standard Deviation 1.72 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8 - How much did they interfere with what you were doing? | 2.27 score on a scale | Standard Deviation 2.08 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How distressing were your intrusive memories? | 5.53 score on a scale | Standard Deviation 1.94 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How much did your intrusive memories affect your work functioning? | 4.53 score on a scale | Standard Deviation 2.75 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8 - How much did they disrupt your concentration? | 2.67 score on a scale | Standard Deviation 2.19 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How much did your intrusive memories affect your work functioning? | 3.97 score on a scale | Standard Deviation 2.81 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How much did they disrupt your concentration? | 6.70 score on a scale | Standard Deviation 1.88 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8 - How much did your intrusive memories affect your work functioning? | 1.93 score on a scale | Standard Deviation 2.27 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How much did they interfere with what you were doing? | 5.42 score on a scale | Standard Deviation 2.3 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How much did your intrusive memories affect your functioning in other areas of your life? | 5.30 score on a scale | Standard Deviation 2.53 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8- How distressing were your intrusive memories? | 2.87 score on a scale | Standard Deviation 2.67 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How much did your intrusive memories affect your functioning in other areas of your life? | 4.42 score on a scale | Standard Deviation 2.78 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How much did they interfere with what you were doing? | 5.13 score on a scale | Standard Deviation 1.99 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8 - How much did your intrusive memories affect your functioning in other areas of your life? | 1.53 score on a scale | Standard Deviation 1.83 |
| Immediate Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How distressing were your intrusive memories? | 6.00 score on a scale | Standard Deviation 1.83 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8 - How much did your intrusive memories affect your functioning in other areas of your life? | 1.58 score on a scale | Standard Deviation 2.57 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How distressing were your intrusive memories? | 6.02 score on a scale | Standard Deviation 1.83 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How distressing were your intrusive memories? | 2.86 score on a scale | Standard Deviation 2.45 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8- How distressing were your intrusive memories? | 2.00 score on a scale | Standard Deviation 2.44 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How much did they disrupt your concentration? | 7.05 score on a scale | Standard Deviation 2.29 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How much did they disrupt your concentration? | 2.74 score on a scale | Standard Deviation 2.76 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8 - How much did they disrupt your concentration? | 1.97 score on a scale | Standard Deviation 2.4 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How much did they interfere with what you were doing? | 5.95 score on a scale | Standard Deviation 2.26 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How much did they interfere with what you were doing? | 2.26 score on a scale | Standard Deviation 2.32 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8 - How much did they interfere with what you were doing? | 1.55 score on a scale | Standard Deviation 2.01 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How much did your intrusive memories affect your work functioning? | 4.71 score on a scale | Standard Deviation 2.64 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How much did your intrusive memories affect your work functioning? | 1.71 score on a scale | Standard Deviation 2.63 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 8 - How much did your intrusive memories affect your work functioning? | 1.00 score on a scale | Standard Deviation 1.65 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Baseline - How much did your intrusive memories affect your functioning in other areas of your life? | 5.55 score on a scale | Standard Deviation 2.21 |
| Delayed Intervention Arm | Intrusive Memory Ratings, Ordinal Items | Week 4 - How much did your intrusive memories affect your functioning in other areas of your life? | 1.89 score on a scale | Standard Deviation 2.35 |
Comparison: ITT analysis for Intrusive memory ratings, 'How distressing were your intrusive memories?' (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/s41398-023-02578-0p-value: <=0.00195% CI: [-3.72, -1.54]Regression, Multilevel Linear
Comparison: 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/s41398-023-02578-0p-value: <=0.00195% CI: [-4.28, -2.15]Regression, Multilevel Linear
Comparison: 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/s41398-023-02578-0p-value: <=0.00195% CI: [-3.9, -1.95]Regression, Multilevel Linear
Comparison: 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/s41398-023-02578-0p-value: <=0.00195% CI: [-3.22, -1.08]Regression, Multilevel Linear
Comparison: 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/s41398-023-02578-0p-value: <=0.00195% CI: [-3.67, -1.51]Regression, Multilevel Linear
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).
Time frame: Run-in/screening week (immediate intervention arm), week 4 (both arms) and week 8 (delayed intervention arm)
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Immediate Intervention Arm | Number of Intrusive Memories of Traumatic Event(s) | Run-in/screening week | 14.00 Number of intrusive memories |
| Immediate Intervention Arm | Number of Intrusive Memories of Traumatic Event(s) | Week 4 | 10.00 Number of intrusive memories |
| Immediate Intervention Arm | Number of Intrusive Memories of Traumatic Event(s) | Week 8 (Delayed Arm Only) | 1.00 Number of intrusive memories |
| Delayed Intervention Arm | Number of Intrusive Memories of Traumatic Event(s) | Run-in/screening week | 14.50 Number of intrusive memories |
| Delayed Intervention Arm | Number of Intrusive Memories of Traumatic Event(s) | Week 4 | 1.00 Number of intrusive memories |
Comparison: Within the comparator arm, where participants had delayed access to the intervention (i.e., delayed arm crossover), the number of intrusive memories in week 8 was compared to week 4. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0p-value: <=0.00195% CI: [0.21, 0.45]Regression, Poisson
Comparison: 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/s41398-023-02578-0p-value: <0.00195% CI: [0.1, 0.45]Regression, Poisson
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).
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Patient Health Questionnaire 2-item Version (PHQ-2) | Baseline | 2.76 Total score of 2-item scale measure | Standard Deviation 1.48 |
| Immediate Intervention Arm | Patient Health Questionnaire 2-item Version (PHQ-2) | Week 4 | 1.53 Total score of 2-item scale measure | Standard Deviation 1.5 |
| Immediate Intervention Arm | Patient Health Questionnaire 2-item Version (PHQ-2) | Week 8 | 1.23 Total score of 2-item scale measure | Standard Deviation 1.61 |
| Delayed Intervention Arm | Patient Health Questionnaire 2-item Version (PHQ-2) | Baseline | 2.26 Total score of 2-item scale measure | Standard Deviation 1.82 |
| Delayed Intervention Arm | Patient Health Questionnaire 2-item Version (PHQ-2) | Week 4 | 1.92 Total score of 2-item scale measure | Standard Deviation 1.62 |
| Delayed Intervention Arm | Patient Health Questionnaire 2-item Version (PHQ-2) | Week 8 | 1.23 Total score of 2-item scale measure | Standard Deviation 1.87 |
Comparison: ITT analysis for Patient Health Questionnaire 2-item version (PHQ-2) (treatment effects for between-arm comparisons) at week 4.p-value: >0.0595% CI: [-1.23, 0.19]Regression, Multilevel Linear
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.
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Psychological Outcome Profiles (PSYCHLOPS) | Baseline | 14.20 Total score of 4-item scale measure | Standard Deviation 3.3 |
| Immediate Intervention Arm | Psychological Outcome Profiles (PSYCHLOPS) | Week 4 | 6.97 Total score of 4-item scale measure | Standard Deviation 4.78 |
| Immediate Intervention Arm | Psychological Outcome Profiles (PSYCHLOPS) | Week 8 | 5.65 Total score of 4-item scale measure | Standard Deviation 4.29 |
| Delayed Intervention Arm | Psychological Outcome Profiles (PSYCHLOPS) | Week 8 | 6.03 Total score of 4-item scale measure | Standard Deviation 4.13 |
| Delayed Intervention Arm | Psychological Outcome Profiles (PSYCHLOPS) | Baseline | 13.29 Total score of 4-item scale measure | Standard Deviation 2.94 |
| Delayed Intervention Arm | Psychological Outcome Profiles (PSYCHLOPS) | Week 4 | 12.13 Total score of 4-item scale measure | Standard Deviation 3.57 |
Comparison: ITT analysis for Psychological Outcome Profiles (PSYCHLOPS) (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [-8.48, -4.51]Regression, Multilevel Linear
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).
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | PTSD Checklist for DSM-5 (PCL-5) 4-item Version | Baseline | 8.71 Total score of 4-item scale measure | Standard Deviation 3.64 |
| Immediate Intervention Arm | PTSD Checklist for DSM-5 (PCL-5) 4-item Version | Week 4 | 4.26 Total score of 4-item scale measure | Standard Deviation 2.86 |
| Immediate Intervention Arm | PTSD Checklist for DSM-5 (PCL-5) 4-item Version | Week 8 | 2.35 Total score of 4-item scale measure | Standard Deviation 3.13 |
| Delayed Intervention Arm | PTSD Checklist for DSM-5 (PCL-5) 4-item Version | Baseline | 8.0 Total score of 4-item scale measure | Standard Deviation 3.27 |
| Delayed Intervention Arm | PTSD Checklist for DSM-5 (PCL-5) 4-item Version | Week 4 | 6.74 Total score of 4-item scale measure | Standard Deviation 2.62 |
| Delayed Intervention Arm | PTSD Checklist for DSM-5 (PCL-5) 4-item Version | Week 8 | 2.87 Total score of 4-item scale measure | Standard Deviation 2.53 |
Comparison: ITT analysis for PTSD Checklist for DSM-5 (PCL-5) 4-item version (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [-3.52, -1.07]Regression, Multilevel Linear
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).
Time frame: Time Frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Baseline - Work Engagement Subscale | 2.19 score on a scale | Standard Deviation 0.53 |
| Immediate Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Week 4 - Work Engagement Subscale | 2.10 score on a scale | Standard Deviation 0.48 |
| Immediate Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Week 8 - Work Engagement Subscale | 2.50 score on a scale | Standard Deviation 0.62 |
| Immediate Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Baseline - Burnout Subscale | 2.33 score on a scale | Standard Deviation 0.5 |
| Immediate Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Week 4 - Burnout Subscale | 2.40 score on a scale | Standard Deviation 0.61 |
| Immediate Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Week 8 - Burnout Subscale | 1.97 score on a scale | Standard Deviation 0.61 |
| Delayed Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Week 4 - Burnout Subscale | 1.80 score on a scale | Standard Deviation 0.54 |
| Delayed Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Baseline - Work Engagement Subscale | 2.03 score on a scale | Standard Deviation 0.46 |
| Delayed Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Baseline - Burnout Subscale | 2.45 score on a scale | Standard Deviation 0.54 |
| Delayed Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Week 4 - Work Engagement Subscale | 2.59 score on a scale | Standard Deviation 0.66 |
| Delayed Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Week 8 - Burnout Subscale | 1.82 score on a scale | Standard Deviation 0.56 |
| Delayed Intervention Arm | Scale of Work Engagement and Burnout (SWEBO) | Week 8 - Work Engagement Subscale | 2.66 score on a scale | Standard Deviation 0.69 |
Comparison: ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Subscale (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [0.2, 0.71]Regression, Multilevel Linear
Comparison: ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Subscale (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [-0.87, -0.34]Regression, Multilevel Linear
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.
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Sickness Absence | Baseline | 3.80 Number of sick days | Standard Deviation 6.91 |
| Immediate Intervention Arm | Sickness Absence | Week 4 | 3.79 Number of sick days | Standard Deviation 7.36 |
| Immediate Intervention Arm | Sickness Absence | Week 8 | 1.42 Number of sick days | Standard Deviation 5.16 |
| Delayed Intervention Arm | Sickness Absence | Baseline | 3.21 Number of sick days | Standard Deviation 6.62 |
| Delayed Intervention Arm | Sickness Absence | Week 4 | 3.45 Number of sick days | Standard Deviation 7.61 |
| Delayed Intervention Arm | Sickness Absence | Week 8 | 1.65 Number of sick days | Standard Deviation 5.47 |
Comparison: ITT analysis for Sickness absence (treatment effects for between-arm comparisons) at week 4.p-value: >0.0595% CI: [0.64, 3.51]Regression, Multilevel Poisson
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).
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Sleep Condition Indicator (SCI) | Baseline | 12.37 Total score of 8-item scale measure | Standard Deviation 7.75 |
| Immediate Intervention Arm | Sleep Condition Indicator (SCI) | Week 4 | 19.13 Total score of 8-item scale measure | Standard Deviation 8.27 |
| Immediate Intervention Arm | Sleep Condition Indicator (SCI) | Week 8 | 20.65 Total score of 8-item scale measure | Standard Deviation 7.75 |
| Delayed Intervention Arm | Sleep Condition Indicator (SCI) | Baseline | 12.71 Total score of 8-item scale measure | Standard Deviation 6.62 |
| Delayed Intervention Arm | Sleep Condition Indicator (SCI) | Week 4 | 12.71 Total score of 8-item scale measure | Standard Deviation 6.06 |
| Delayed Intervention Arm | Sleep Condition Indicator (SCI) | Week 8 | 19.23 Total score of 8-item scale measure | Standard Deviation 7.55 |
Comparison: ITT analysis for Sleep Condition Indicator (SCI) (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [2.56, 8.2]Regression, Multilevel Linear
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).
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Weekly Work Pattern, Number of Days Worked | Baseline - On how many days did you work this week? | 3.14 Days worked | Standard Deviation 1.81 |
| Immediate Intervention Arm | Weekly Work Pattern, Number of Days Worked | Week 4 - On how many days did you work this week? | 3.26 Days worked | Standard Deviation 1.78 |
| Immediate Intervention Arm | Weekly Work Pattern, Number of Days Worked | Week 8 - On how many days did you work this week? | 2.83 Days worked | Standard Deviation 1.58 |
| Delayed Intervention Arm | Weekly Work Pattern, Number of Days Worked | Baseline - On how many days did you work this week? | 3.21 Days worked | Standard Deviation 1.8 |
| Delayed Intervention Arm | Weekly Work Pattern, Number of Days Worked | Week 4 - On how many days did you work this week? | 2.66 Days worked | Standard Deviation 2.13 |
| Delayed Intervention Arm | Weekly Work Pattern, Number of Days Worked | Week 8 - On how many days did you work this week? | 3.48 Days worked | Standard Deviation 1.84 |
Comparison: ITT analysis for number of days worked (treatment effects for between-arm comparisons) at week 4.p-value: >0.0595% CI: [0.6, 1.07]Regression, Multilevel Poisson
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).
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Weekly Work Pattern, Number of Night Shifts Worked | Baseline | 0.65 Nights worked | Standard Deviation 1.07 |
| Immediate Intervention Arm | Weekly Work Pattern, Number of Night Shifts Worked | Week 4 | 0.55 Nights worked | Standard Deviation 1.01 |
| Immediate Intervention Arm | Weekly Work Pattern, Number of Night Shifts Worked | Week 8 | 0.57 Nights worked | Standard Deviation 0.97 |
| Delayed Intervention Arm | Weekly Work Pattern, Number of Night Shifts Worked | Baseline | 1.0 Nights worked | Standard Deviation 1.36 |
| Delayed Intervention Arm | Weekly Work Pattern, Number of Night Shifts Worked | Week 4 | 0.83 Nights worked | Standard Deviation 1.25 |
| Delayed Intervention Arm | Weekly Work Pattern, Number of Night Shifts Worked | Week 8 | 0.77 Nights worked | Standard Deviation 1.18 |
Comparison: ITT analysis for number of nights worked (treatment effects for between-arm comparisons) at week 4.p-value: <0.0595% CI: [0.57, 2.09]Regression, Multilevel Poisson
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).
Time frame: Baseline, 4 weeks and 8 weeks
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | Baseline | 25.0 Total score of 12-item scale measure | Standard Deviation 15.23 |
| Immediate Intervention Arm | World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | Week 4 | 13.54 Total score of 12-item scale measure | Standard Deviation 11.94 |
| Immediate Intervention Arm | World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | Week 8 | 10.76 Total score of 12-item scale measure | Standard Deviation 10.65 |
| Delayed Intervention Arm | World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | Baseline | 21.88 Total score of 12-item scale measure | Standard Deviation 14.96 |
| Delayed Intervention Arm | World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | Week 4 | 22.37 Total score of 12-item scale measure | Standard Deviation 14.4 |
| Delayed Intervention Arm | World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | Week 8 | 11.90 Total score of 12-item scale measure | Standard Deviation 14.55 |
Comparison: ITT analysis for World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0) (treatment effects for between-arm comparisons) at week 4.p-value: <=0.00195% CI: [-15.06, -4.5]Regression, Multilevel Linear
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).
Time frame: 4 weeks and 8 weeks (both arms)
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Arm | Changes to Health and Work - Continuous Outcomes | Week 4 - How many new work-related traumatic events have you experienced/witnessed? | 3.2 Number of events experienced/witnessed | Standard Deviation 6.7 |
| Immediate Intervention Arm | Changes to Health and Work - Continuous Outcomes | Week 8 - How many new work-related traumatic events have you experienced/witnessed? | 1.5 Number of events experienced/witnessed | Standard Deviation 3.8 |
| Immediate Intervention Arm | Changes to Health and Work - Continuous Outcomes | Week 4 - How many new traumatic events that were not work-related have you experienced/witnessed? | 0.2 Number of events experienced/witnessed | Standard Deviation 0.6 |
| Immediate Intervention Arm | Changes to Health and Work - Continuous Outcomes | Week 8 - How many new traumatic events that were not work-related have you experienced/witnessed? | 0.1 Number of events experienced/witnessed | Standard Deviation 0.3 |
| Delayed Intervention Arm | Changes to Health and Work - Continuous Outcomes | Week 8 - How many new traumatic events that were not work-related have you experienced/witnessed? | 0.4 Number of events experienced/witnessed | Standard Deviation 1.08 |
| Delayed Intervention Arm | Changes to Health and Work - Continuous Outcomes | Week 4 - How many new work-related traumatic events have you experienced/witnessed? | 1.6 Number of events experienced/witnessed | Standard Deviation 2.8 |
| Delayed Intervention Arm | Changes to Health and Work - Continuous Outcomes | Week 4 - How many new traumatic events that were not work-related have you experienced/witnessed? | 0.1 Number of events experienced/witnessed | Standard Deviation 0.5 |
| Delayed Intervention Arm | Changes to Health and Work - Continuous Outcomes | Week 8 - How many new work-related traumatic events have you experienced/witnessed? | 2.3 Number of events experienced/witnessed | Standard Deviation 3.5 |
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).
Time frame: 4 weeks and 8 weeks (both arms)
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Immediate Intervention Arm | Changes to Health and Work - Discrete Outcomes | Week 4 - Have you experienced or witnessed any new work-related traumatic events? | Yes | 19 Participants |
| Immediate Intervention Arm | Changes to Health and Work - Discrete Outcomes | Week 4 - Have you experienced or witnessed any new work-related traumatic events? | No | 19 Participants |
| Immediate Intervention Arm | Changes to Health and Work - Discrete Outcomes | Week 8 -Have you experienced or witnessed any new work-related traumatic events? | Yes | 9 Participants |
| Immediate Intervention Arm | Changes to Health and Work - Discrete Outcomes | Week 8 -Have you experienced or witnessed any new work-related traumatic events? | No | 22 Participants |
| Delayed Intervention Arm | Changes to Health and Work - Discrete Outcomes | Week 8 -Have you experienced or witnessed any new work-related traumatic events? | No | 15 Participants |
| Delayed Intervention Arm | Changes to Health and Work - Discrete Outcomes | Week 4 - Have you experienced or witnessed any new work-related traumatic events? | Yes | 11 Participants |
| Delayed Intervention Arm | Changes to Health and Work - Discrete Outcomes | Week 8 -Have you experienced or witnessed any new work-related traumatic events? | Yes | 16 Participants |
| Delayed Intervention Arm | Changes to Health and Work - Discrete Outcomes | Week 4 - Have you experienced or witnessed any new work-related traumatic events? | No | 17 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.
Time frame: Week 4 (immediate intervention arm), Week 8 (delayed intervention arm)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Arm | Feedback Questionnaire | 63.79 Total summed score of 8-items | Standard Deviation 11.54 |
| Delayed Intervention Arm | Feedback Questionnaire | 65.14 Total summed score of 8-items | Standard Deviation 13.58 |
Other Pre-specified
Optimisation Assessment
Rates of recruitment, intervention use/adherence, outcome measure completion and participant attrition will be assessed.
Time frame: Baseline, 4 weeks and 8 weeks
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.
Time frame: Week 5 (immediate intervention arm), Week 9 (delayed intervention arm)
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
Time frame: Baseline
Population: Analyses were completed on an intention-to-treat basis. Please see Participant Flow.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | Moderately | 9 Participants |
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | Not at all | 1 Participants |
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | A little bit | 15 Participants |
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | Quite a bit | 7 Participants |
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | Moderately | 10 Participants |
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | Not at all | 6 Participants |
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | Quite a bit | 9 Participants |
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | Extremely | 4 Participants |
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | Extremely | 11 Participants |
| Immediate Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | A little bit | 10 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | Extremely | 13 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | Not at all | 9 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | A little bit | 14 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | Moderately | 10 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | Quite a bit | 7 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your supervisors/managers? | Extremely | 2 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | Not at all | 1 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | A little bit | 2 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | Moderately | 11 Participants |
| Delayed Intervention Arm | Support From Managers and From Family/Friends | How well supported have you been by your family & friends? | Quite a bit | 15 Participants |