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

NCT ID: NCT05616676

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2024-03-19

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.

Conditions

Intrusive Memories of Traumatic Event(s)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brief digital imagery-competing task

Access to a brief digital imagery-competing task for 24 weeks (first 4 weeks with optional researcher support).

Group Type: EXPERIMENTAL

Brief digital imagery-competing task

Intervention Type: BEHAVIORAL

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.

Brief digital music-listening task

Access to a brief digital music-listening task for 24 weeks (first 4 weeks with optional researcher support).

Group Type: EXPERIMENTAL

Brief digital music-listening task

Intervention Type: BEHAVIORAL

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.

Treatment As Usual

Access to routine care that participants would otherwise receive if having intrusive memories of traumatic events for 24 weeks.

Group Type: EXPERIMENTAL

Treatment As Usual

Intervention Type: OTHER

Access to routine care that participants would otherwise receive if having intrusive memories of traumatic events.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Treatment As Usual

Access to routine care that participants would otherwise receive if having intrusive memories of traumatic events.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wellcome Trust

OTHER

Sponsor Role: collaborator

Uppsala University (Department of Psychology)

UNKNOWN

Sponsor Role: collaborator

Intensive Care Society (Communication Department)

UNKNOWN

Sponsor Role: collaborator

University of Nottingham (Institute of Mental Health)

UNKNOWN

Sponsor Role: collaborator

P1vital Products Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Holmes

Role: PRINCIPAL_INVESTIGATOR

Uppsala University (UU), Sweden

Locations

P1vital Products Ltd

Wallingford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

P1V-GAINS-IN02

Identifier Type: -

Identifier Source: org_study_id