Intrusive Memories of Traumatic Event(s)
Conditions
Brief summary
Frontline healthcare 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: they can disrupt functioning and can contribute to post-traumatic 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 will test the effect of a digital imagery-competing task, a digital music-listening task and treatment as usual (TAU) for National Health Service (NHS) staff with intrusive memories of work-related traumatic events from the pandemic. We test the effect on the number of intrusive memories (primary outcome), and other clinical symptoms (PTSD, anxiety, depression, and insomnia), in addition to work functioning, general functioning and quality of life (secondary outcomes). Intervention feasibility, acceptability and implementation will also be explored (additional outcomes). We will recruit approximately 150 NHS staff (via the Intensive Care Society, social media and direct advertising by NHS Trusts) with intrusive memories of traumatic 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 will be prepared prior to the first interim analysis using Bayesian analyses for statistical inference. Regular monitoring will be 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
First session guided by a researcher: A memory cue followed by playing a computer game with mental rotation instructions. Option to engage in self-administered/guided sessions after the first session.
BEHAVIORALBrief digital music-listening task
First session guided by a researcher: Information about the composer's music followed by listening to classical music. Option to engage in self-administered/guided sessions after the first session.
OTHERTreatment As Usual
Access to routine care that participants would otherwise receive if having intrusive memories of traumatic events.
Sponsors
P1vital Products Limited
Wellcome Trust
Uppsala University
Intensive Care Society (Communication Department)
University of Nottingham
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 with COVID-19 patients in the NHS during the COVID-19 pandemic. * Experienced at least one traumatic event related to their clinical work during the COVID- 9 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 * Willing and able to be contacted by the research team during the study period. * Have not taken part in a previous study of this intervention from this research team
Exclusion criteria
• Have fewer than three intrusive memories during the run-in week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Intrusive Memories of Traumatic Event(s) | Run-in/screening week, Week 4 (all arms) | Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Intrusive Memories of Traumatic Event(s) | Run-in/Screening week, Weeks 12 and 24 (all arms) | Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days. |
| PTSD Checklist for DSM-5 (PCL-5) | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | This 20-item measure assesses symptoms of PTSD over the last week. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Scores are summed to give a total severity score (ranging 0 to 80), with greater scores indicating greater symptom severity. |
| Sleep Condition Indicator (SCI) | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | This 2-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 0-8, with a higher score indicating better sleep. |
| Generalised Anxiety Disorder 2-item Scale (GAD-2) | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | This 2-item short-form self-report measure assesses symptoms of anxiety. 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, with greater scores indicating greater symptom severity. |
| Patient Health Questionnaire 2-item Version (PHQ-2) | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | 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, with greater scores indicating greater symptom severity. |
| Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Total Score | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | This 19-item self-report measure assesses work engagement and burnout. The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication). The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness). Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time). The work engagement subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work engagement. |
| Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Total Score | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | This 19-item self-report measure assesses work engagement and burnout. The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication). The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness). Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time). The work burnout subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work burnout. |
| Sickness Absence | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | Single item assessing self-reported number of sick days taken from work in the last 4 weeks. |
| Intention to Leave Job | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | 3 items 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. |
| 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Mobility | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The mobility item is scored on a 5-point ordinal scale from "I have no problems in walking about" to "I am unable to walk about". |
| 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Self Care | Baseline, Week 4, Week 12 and Week 24 | The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The self care item is scored on a 5-point ordinal scale from "I have no problems washing or dressing myself" to "I am unable to wash or dress myself". |
| 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Usual Activities | Baseline, Week 4, Week 12 and Week 24 | The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The usual activities item is scored on a 5-point ordinal scale from "I have no problems doing my usual activities" to "I am unable to do my usual activities". |
| 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Pain / Discomfort | Baseline, Week 4, Week 12 and Week 24 | The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The pain / discomfort item is scored on a 5-point ordinal scale from "I have no pain or discomfort" to "I have extreme pain or discomfort". |
| 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Anxiety / Depression | Baseline, Week 4, Week 12 and Week 24 | The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The anxiety / depression item is scored on a 5-point ordinal scale from "I am not anxious or depressed" to "I am extremely anxious or depressed". |
| 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Overall Health | Baseline, Week 4, Week 12 and Week 24 | The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief measure for assessing general quality of life and health status. Respondents 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). |
| World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0) | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | 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), with greater scores indicating greater impairment. |
| Intrusive Memory Ratings: Item 1. Approximately How Often Did Intrusive Memories of the Traumatic Event Pop Into Your Mind? | Baseline, 4 weeks, 12 weeks and 24 weeks (all arms) | This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '\<1min' to '\>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present Item 1 assessing the frequency of intrusive memories on a 7-point scale from 'never' to 'many times a day'. Other items from this questionnaire are presented below. |
| Intrusive Memory Ratings: Item 4a. Duration of Interference | Baseline, Week 4, Week 12 and Week 24 (all arms) | This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '\<1min' to '\>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present Item 4a assessing the for how long intrusive memories interfered with what participants were doing on a 7-point scale from '\<1 min' to '\>60 mins'. Other items from this questionnaire are presented below. |
| Intrusive Memory Ratings: Distress (Item 2), Disruption to Concentration (Item 3), Interference (Item 4), Impact on Work Functioning (Item 5), and Impact on Functioning in Other Areas of Life (Item 7) | Baseline, Week 4, Week 12 and Week 24 (all arms) | This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '\<1min' to '\>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present data for the five items scored on an 11-point scale (0=not at all to 10=extremely) assessing distress (Item 2), disruption to concentration (Item 3), interference (Item 4), impact on work functioning (Item 5), and impact on functioning in other areas of life (Item 7). |
Countries
United Kingdom
Contacts
STUDY_DIRECTOREmily Holmes
Uppsala University (UU), Sweden
PRINCIPAL_INVESTIGATORAmy Beckenstrom
P1vital Products, Wallingford
Participant flow
Recruitment details
Between 08 December 2022 and 15 September 2023, 176 participants were screened via online questionnaires, with 122 eligible participants subsequently providing informed consent and commencing the run-in/screening week.
Pre-assignment details
Prior to randomisation, nine participants were excluded for having fewer than three IMs in the baseline IM diary, eight were lost to follow-up, and six withdrew prior to randomisation. These participants are detailed in the 'Run-in week only (non-randomised)' arm in the Participant Flow.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.2 Years STANDARD_DEVIATION 10.2 |
| Categories of Work-Related Traumatic Events Experienced A severe or unsuccessful resuscitation | 15 Participants |
| Categories of Work-Related Traumatic Events Experienced A traumatic or tragic death of a patient | 35 Participants |
| Categories of Work-Related Traumatic Events Experienced A traumatic or tragic event where a patient reminded you of yourself, a family member or friend | 64 Participants |
| Categories of Work-Related Traumatic Events Experienced Being faced with suicide / suicide attempt | 15 Participants |
| Categories of Work-Related Traumatic Events Experienced Event involving extremely distressed/grieving relatives of patients | 29 Participants |
| Categories of Work-Related Traumatic Events Experienced Event involving sudden increased risk of COVID-19 infection | 26 Participants |
| Categories of Work-Related Traumatic Events Experienced Other | 7 Participants |
| Categories of Work-Related Traumatic Events Experienced Situation where the care of a patient failed or did not go as planned | 72 Participants |
| Categories of Work-Related Traumatic Events Experienced Threats or violence against healthcare professionals | 19 Participants |
| Categories of Work-Related Traumatic Events Experienced Witnessing events surrounding colleague who has fallen ill or died of COVID-19 | 23 Participants |
| Employment status Other | 4 Participants |
| Employment status Retired | 1 Participants |
| Employment status Sick leave | 1 Participants |
| Employment status Student | 3 Participants |
| Employment status Working full time | 74 Participants |
| Employment status Working part time | 3 Participants |
| Experiences of Prior Trauma Number of non-work-related traumatic events experienced/witnessed during COVID-19. | 2.2 Number of events STANDARD_DEVIATION 4.8 |
| Experiences of Prior Trauma Number of work-related traumatic events experienced/witnessed during COVID-19. | 50.8 Number of events STANDARD_DEVIATION 94.2 |
| Health Background Are you receiving any current treatments/medications for these? No | 24 Participants |
| Health Background Are you receiving any current treatments/medications for these? Yes | 15 Participants |
| Health Background Current mental health problem No | 11 Participants |
| Health Background Current mental health problem Yes | 16 Participants |
| Health Background Have you been treated for/diagnosed with any mental health problems? No | 29 Participants |
| Health Background Have you been treated for/diagnosed with any mental health problems? Yes | 70 Participants |
| Health Background Past mental health problem No | 9 Participants |
| Health Background Past mental health problem Yes | 41 Participants |
| Highest level of education Bachelor's degree or equivalent | 28 Participants |
| Highest level of education Master's degree | 4 Participants |
| Highest level of education Secondary school (to age 16) | 1 Participants |
| Highest level of education Sixth form or equivalent (to age 18) | 3 Participants |
| Hours working per week | 33.8 Hours (per week) STANDARD_DEVIATION 13.5 |
| Marital Status Divorced or separated | 2 Participants |
| Marital Status Living apart from partner | 7 Participants |
| Marital Status Married or cohabiting | 21 Participants |
| Marital Status Other | 0 Participants |
| Marital Status Single | 7 Participants |
| Marital Status Widowed | 0 Participants |
| NHS Job Role Allied Health Professionals | 4 Participants |
| NHS Job Role Doctors | 1 Participants |
| NHS Job Role Healthcare Support Worker | 3 Participants |
| NHS Job Role Missing | 31 Participants |
| NHS Job Role Nursing | 47 Participants |
| NHS Job Role Other/unknown | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Chinese | 0 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White | 34 Participants |
| Region of Enrollment United Kingdom | 40 Participants |
| Sex/Gender, Customized Gender-variant/non-binary | 1 Participants |
| Sex/Gender, Customized Man | 2 Participants |
| Sex/Gender, Customized Other | 1 Participants |
| Sex/Gender, Customized Woman | 34 Participants |
| Time as healthcare professional | 15.6 Years STANDARD_DEVIATION 9.4 |
| Timeframe of Work-Related Traumatic Events Experienced Between 1-3 months ago Not selected | 97 Participants |
| Timeframe of Work-Related Traumatic Events Experienced Between 1-3 months ago Selected | 0 Participants |
| Timeframe of Work-Related Traumatic Events Experienced More than 3 months ago Not selected | 4 Participants |
| Timeframe of Work-Related Traumatic Events Experienced More than 3 months ago Selected | 24 Participants |
| Timeframe of Work-Related Traumatic Events Experienced Ongoing exposure to traumatic events is part of my job during the COVID-19 pandemic Not selected | 12 Participants |
| Timeframe of Work-Related Traumatic Events Experienced Ongoing exposure to traumatic events is part of my job during the COVID-19 pandemic Selected | 8 Participants |
| Timeframe of Work-Related Traumatic Events Experienced Within the last 24 hours Not selected | 38 Participants |
| Timeframe of Work-Related Traumatic Events Experienced Within the last 24 hours Selected | 1 Participants |
| Timeframe of Work-Related Traumatic Events Experienced Within the past month Not selected | 39 Participants |
| Timeframe of Work-Related Traumatic Events Experienced Within the past month Selected | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 40 | 0 / 20 | 0 / 122 |
| other Total, other adverse events | 6 / 39 | 2 / 40 | 0 / 20 | 3 / 122 |
| serious Total, serious adverse events | 3 / 39 | 3 / 40 | 0 / 20 | 0 / 122 |
Outcome results
None listed