NCT05616676

A Brief Cognitive Task Intervention for NHS Staff Affected by COVID-19 Trauma (GAINS-2 Study)

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: P1vital Products Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intrusive Memories of Traumatic Event(s)

Interventions

Type	Name	Description
BEHAVIORAL	Brief 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.
BEHAVIORAL	Brief 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.
OTHER	Treatment As Usual	Access to routine care that participants would otherwise receive if having intrusive memories of traumatic events.

Timeline

• Start date: 2022-12-08
• Primary completion: 2023-10-30
• Completion: 2024-03-19
• First posted: 2022-11-15
• Last updated: 2024-03-22

Locations

1 site across 1 country: United Kingdom