A Brief Cognitive Task Intervention for NHS Staff Affected by COVID-19 Trauma (GAINS-2 Study)
Study Details
Study Description
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 lead to post-traumatic stress disorder. Previous research has shown that a brief behavioural intervention can reduce the number of intrusive memories people have after a traumatic event. In this study we will test the efficacy of the imagery-competing task against an alternative brief cognitive task (a 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 and 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 the NHS Trusts) with intrusive memories of traumatic events they have experienced during the COVID-19 pandemic.
The study is funded by the Wellcome Trust (223016/Z/21/Z).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A statistical analysis plan will be prepared prior to the first interim analysis using Bayesian analyses for statistical inference. For primary and secondary outcomes, the posterior probability distribution of the effect size and its 95% credible interval will be reported. Intention-to-treat analysis will include all participants who have been randomised.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brief imagery-competing task Intervention Completing a guided digital task by participants through accessing a brief digital imagery-competing task for the first time while having the option of researcher support for the first 4 weeks and retaining access to the task for the reminder of the study duration. |
Behavioral: Brief imagery-competing task
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).
|
| Experimental: Brief music-listening task Intervention Completing a guided digital task by participants through accessing a brief digital music listening task for the first time while having the option of researcher support for the first 4 weeks and retaining access to the task for the reminder of the study duration. |
Behavioral: Brief music-listening task
First session guided by a researcher: listening to classical music (Mozart) for 20-minutes following a podcast about Mozart.
Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring).
|
| Experimental: Treatment As Usual Retaining access to routine care that participants would otherwise receive if having intrusive memories of traumatic events for 24 weeks (study duration). |
Other: Treatment As Usual
Access to routine care that participants would otherwise receive if having intrusive memories of traumatic events.
|
Outcome Measures
Primary Outcome Measures
- Primary Outcome Measure: [[Time Frame: Week 4 (all arms) and controlling for run in week/baseline (both arms)]]
Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
Secondary Outcome Measures
- Number of intrusive memories of traumatic event(s) [[Time Frame: Week 12 and 24 (all arms) and controlling for run in week/baseline (both 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) [[Time Frame: Week 4, 12 and 24 (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).
- Sleep Condition Indicator (SCI) [[Time Frame: Baseline, Week 4, Week12 and 24 (all arms)]]
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.
- Generalised Anxiety Disorder 2-item scale (GAD-2) [[Time Frame: Baseline, Week 4, Week12 and 24 (all arms)]]
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.
- Patient Health Questionnaire 2-item version (PHQ-2) [[Time Frame: Baseline, Week 4, Week12 and 24 (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.
- Scale of Work Engagement and Burnout (SWEBO) [[Time Frame: Baseline, Week 4, Week12 and 24 (all arms)]]
This 18-item self-report measure assesses work engagement and burnout. The work engagement subscale consists of 9 items assessing three dimensions (vigour, attentiveness, dedication). 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 mean score is calculated for two subscales: engagement and burnout (9 items each).
- Sickness absence [[Time Frame: Baseline, Week 4, Week12 and 24 (all arms)]]
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 [[Time Frame: Baseline, Week 4, Week12 and 24 (all arms)]]
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.
- 5-level European Quality of Life 5 Dimension (EQ-5D-5L) [[Time Frame: Baseline, Week 4, Week12 and 24 (all arms)]]
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 rate their overall health today from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Scores are analysed separately (not summed).
- World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0) [[Time Frame: Baseline, Week 4, Week12 and 24 (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).
- Intrusive memory ratings [[Time Frame: Baseline, Week 4, Week12 and 24 (all arms)]]
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)).
Other Outcome Measures
- Changes to health and work [[Time Frame: Week 4, Week12 and 24 (all arms)]]
The 6-item questionnaire questionnaire will be used to assess the occurrence of any new traumatic events, 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.
- Feedback questionnaire [[Time Frame: Week 4 (brief Imagery competing task and brief music listening task arms only)]]
The first ten 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, each rated from 0 (not at all) to 10 (very). The last two items ask how the intervention could be improved, for any other comments or suggestions about the intervention, and for the occurrence of any adverse events, all with an open response.
- Optional qualitative interview [[Time Frame: Week 4 (brief Imagery competing task and brief music listening task arms only)]]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18 or above.
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Able to read, write and speak in English.
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Worked in a clinical role with COVID-19 patients in the NHS during the COVID-19
-
pandemic
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Experienced at least one traumatic event related to their clinical 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".
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Experience intrusive memories of the traumatic event(s).
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Experienced at least three intrusive memories in the week prior to screening.
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Have internet access.
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Willing and able to provide informed consent and complete study procedures
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Willing and able to be contacted by the research team during the study period.
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Have not taken part in a previous study of this intervention from this research team (e.g.GAINS-01)
Exclusion Criteria:
• Have fewer than three intrusive memories during the run-in week. We will not exclude those undergoing other treatment for post-traumatic stress disorder (PTSD) or its symptoms, so the study is as inclusive as possible to meet the challenges NHS staff are facing during their work related to the COVID-19 pandemic.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- P1vital Products Limited
- Wellcome Trust (Funder)
- Uppsala University (Department of Psychology)
- Intensive Care Society (Communication Department)
- University of Oxford (Department of Biology)
- University of Nottingham (Institute of Mental Health)
Investigators
- Principal Investigator: Emily Holmes, Uppsala University (UU), Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P1V-GAINS-IN02