Clinical trial NCT05616676: A Brief Cognitive Task Intervention for NHS Staff Affected by COVID-19 Trauma (GAINS-2 Study)
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories of Traumatic Event(s)
Lead sponsor: P1vital Products Limited
Sponsor class: INDUSTRY
Collaborators: name: Wellcome Trust
name: Uppsala University (Department of Psychology)
name: Intensive Care Society (Communication Department)
name: University of Nottingham (Institute of Mental Health)
First posted: 2022-11-15
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of intrusive memories of traumatic event(s)
timeFrame: Week 4 (all arms) controlling for run-in/baseline week
Secondary outcomes:
measure: Number of intrusive memories of traumatic event(s)
timeFrame: Weeks 12 and 24 (all arms) controlling for run-in/baseline week
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
measure: Sleep Condition Indicator (SCI)
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
measure: Generalised Anxiety Disorder 2-item scale (GAD-2)
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
measure: Patient Health Questionnaire 2-item version (PHQ-2)
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
measure: Scale of Work Engagement and Burnout (SWEBO)
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
measure: Sickness absence
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
measure: Intention to leave job
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
measure: 5-level European Quality of Life 5 Dimension (EQ-5D-5L)
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
measure: World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0)
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
measure: Intrusive memory ratings
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
Other outcomes:
measure: Changes to health and work
timeFrame: 4 weeks, 12 weeks and 24 weeks (all arms)
measure: Feedback questionnaire
timeFrame: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
measure: Optional qualitative interview
timeFrame: At 4 weeks and at 12-24 weeks (brief imagery competing task and brief music listening task arms only)
Locations:
city: Wallingford
country: United Kingdom
facility: P1vital Products Ltd
state: Oxfordshire
Study officials:
affiliation: Uppsala University (UU), Sweden
name: Emily Holmes
role: PRINCIPAL_INVESTIGATOR
References: