A Brief Cognitive Task Intervention for NHS Staff affected by COVID-19
Research type
Research Study
Full title
A randomised controlled trial of a brief cognitive task intervention to support NHS staff experiencing intrusive memories of traumatic events from working in the COVID-19 pandemic.
IRAS ID
319600
Contact name
Lalitha Iyadurai
Contact email
Sponsor organisation
P1vital Products Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 0 days
Research summary
Research 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 intervention 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) at 4, 12 and 24 weeks. Intervention feasibility, acceptability and implementation will be explored (additional outcomes) at 4, 12 and 24 weeks.
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. Staff will record a daily count of their intrusive memories for a week. Those who continue to be eligible will complete baseline questionnaires and be randomly allocated to receive the intervention, active control or treatment as usual for 24 weeks. The digital intervention or the control task will take about 40 minutes in a first session guided by a researcher, and after that can be done self-guided (with optional researcher support for the first 4 weeks). There is no need to meet in person. Participants will be asked to complete online questionnaires about their work functioning and mental health after 4, 12 and 24 weeks. There will be the option to take part in a feedback interview at the end of 4 weeks for those allocated to the intervention or active control. The study, funded by the Wellcome Trust, will last approximately 11 months, and will test the efficacy of the intervention and support the scalability and implementation of this self-management tool for healthcare staff routinely exposed to trauma at work who experience intrusive memories.Summary of Results
Participants in the intervention arm had fewer intrusive memories of traumatic events in week 4 compared to participants in the active control arm and treatment as usual arm. Final analysis showed 'extremely strong' evidence of a positive treatment effect of the intervention compared to the active control and 'strong' evidence of a positive treatment effect for the intervention compared to TaU. Participants in the Active Control and TaU groups recorded 3.63 and 3.35 times the number of intrusive memories compared to those in the Intervention group in week 4. Effects were similar across all planned sensitivity analyses of the primary outcome, including in planned frequentist analysis of the primary outcome, where number of intrusive memories was observed to be significantly lower at week 4 in the intervention arm compared to either the active control or treatment as usual arms.The number of Intrusive memories recorded by Intervention participants after accessing the intervention remained consistently low at weeks 12 and 24. Between groups analysis indicated 'extreme' evidence of a greater number of Intrusive memories recorded by participants in either comparator groups, at weeks 12 and 24, compared to the intervention group. 'Extreme' evidence of lower PTSD symptomology was also observed in the intervention arm compared with either the active control or treatment as Usual arm, at week 4 and sustained through follow-up at week 12 and week 24. Evidence also supported longer term benefits of the intervention on insomnia (SCI-2) and functional (WHODAS) measures at both week 12 and week 24. Evidence for intervention benefits on other clinical, quality of life and occupational outcomes was more mixed or limited.
In-study interim analyses revealed no evidence of a negative treatment effect, in that there was at no point evidence that the intervention was associated with higher numbers of intrusive memories at week 4 compared with TaU. From an early stage in the trial there was at least 'strong' evidence against such a negative treatment effect of the intervention. All serious adverse events (SAEs) were unrelated to the study and intervention.
REC name
Wales REC 4
REC reference
22/WA/0277
Date of REC Opinion
11 Oct 2022
REC opinion
Favourable Opinion