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

NCT05616676 | Completed DMC

• 1 other identifier: P1V-GAINS-IN02
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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).

Conditions

Intrusive Memories of Traumatic Event(s)

Outcome Measures

Primary Outcomes (1)

• Number of intrusive memories of traumatic event(s)

  Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.

  Week 4 (all arms) controlling for run-in/baseline week

Secondary Outcomes (11)

• Number of intrusive memories of traumatic event(s)

  Weeks 12 and 24 (all arms) controlling for run-in/baseline week

• PTSD Checklist for DSM-5 (PCL-5)

  Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)

• Sleep Condition Indicator (SCI)

  Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)

• Generalised Anxiety Disorder 2-item scale (GAD-2)

  Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)

• Patient Health Questionnaire 2-item version (PHQ-2)

  Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)

Other Outcomes (3)

• Changes to health and work

  4 weeks, 12 weeks and 24 weeks (all arms)

• Feedback questionnaire

  After 4 weeks (brief imagery-competing task and brief music listening task arms only)

• Optional qualitative interview

  At 4 weeks and at 12-24 weeks (brief imagery competing task and brief music listening task arms only)

Study Arms (3)

Brief digital imagery-competing task

EXPERIMENTAL

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

Behavioral: Brief digital imagery-competing task

Brief digital music-listening task

EXPERIMENTAL

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

Behavioral: Brief digital music-listening task

Treatment As Usual

EXPERIMENTAL

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

Other: Treatment As Usual

Interventions

Brief digital imagery-competing task 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 imagery-competing task

Brief digital music-listening task 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.

Brief digital music-listening task

Treatment As Usual OTHER

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

Treatment As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have fewer than three intrusive memories during the run-in week.

Sponsors & Collaborators

• P1vital Products Limited: lead
• Wellcome Trust: collaborator
• Uppsala University (Department of Psychology): collaborator
• Intensive Care Society (Communication Department): collaborator
• University of Nottingham: collaborator

Study Sites (1)

P1vital Products Ltd

Wallingford, Oxfordshire, OX10 8BA, United Kingdom

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Emily Holmes

  Uppsala University (UU), Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 15, 2022
• Study Start: December 8, 2022
• Primary Completion: October 30, 2023
• Study Completion: March 19, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The Study Protocol and Statistical Analysis Plan were uploaded to the Open Science Framework (OSF) prior to the last participant completing the last visit. Results of the study will be shared through open access publications. On publication of the main study results, the associated database of individual participant data (anonymised), data dictionary, and analysis scripts will be made available on OSF. The information described above will be shared indefinitely and with no end date on the OSF platform.
• Access Criteria: The information described above will be made available on the OSF indefinitely. OSF is an open source web application that is freely accessible to the public and scientific community.

Locations

GB (1)