N/A N=122 Randomized Single-blind Treatment

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

Intrusive Memories of Traumatic Event(s)

Bottom Line

View on ClinicalTrials.gov: NCT05616676 ↗

Enrolled (actual)

122

Serious AEs

2.7%

Results posted

May 2026

Primary outcome: Primary: Number of Intrusive Memories of Traumatic Event(s) — 6.50; 9.0; 11.5; 5.0 Number of intrusive memories

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Brief digital imagery-competing task (Behavioral); Brief digital music-listening task (Behavioral); Treatment As Usual (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: P1vital Products Limited
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Intrusive Memories of Traumatic Event(s)	6.5; 9.0; 11.5; 3.0; 4.50; 0.0	—
SECONDARY Number of Intrusive Memories of Traumatic Event(s)	6.5; 9.0; 11.5; 3.0; 4.50; 0.0	—
SECONDARY PTSD Checklist for DSM-5 (PCL-5)	34.95; 32.64; 32.35; 30.94; 26.85; 13.84	—
SECONDARY Sleep Condition Indicator (SCI)	2.60; 3.28; 3.03; 2.82; 3.93; 3.96	—
SECONDARY Generalised Anxiety Disorder 2-item Scale (GAD-2)	2.90; 2.44; 2.90; 2.53; 2.33; 1.63	—
SECONDARY Patient Health Questionnaire 2-item Version (PHQ-2)	2.25; 2.10; 2.10; 2.18; 1.63; 0.83	—
SECONDARY Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Total Score	2.22; 2.09; 2.00; 2.16; 2.30; 2.45	—
SECONDARY Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Total Score	2.21; 2.20; 2.25; 2.21; 2.05; 1.69	—
SECONDARY Sickness Absence	1.65; 2.79; 1.35; 0.06; 1.31; 3.17	—
SECONDARY Intention to Leave Job	10.55; 9.54; 9.58; 9.71; 8.58; 10.58	—
SECONDARY 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Mobility	19; 24; 31; 1; 10; 7	—
SECONDARY 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Self Care	18; 34; 33; 1; 4; 3	—
SECONDARY 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Usual Activities	13; 19; 21; 7; 12; 11	—
SECONDARY 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Pain / Discomfort	9; 16; 12; 8; 11; 17	—
SECONDARY 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Anxiety / Depression	3; 7; 6; 8; 17; 15	—
SECONDARY 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Overall Health	70.80; 71.79; 66.40; 74.53; 70.08; 73.04	—
SECONDARY World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0)	15.63; 21.37; 23.55; 16.42; 18.27; 15.02	—
SECONDARY Intrusive Memory Ratings: Item 1. Approximately How Often Did Intrusive Memories of the Traumatic Event Pop Into Your Mind?	0; 0; 0; 1; 0; 0	—
SECONDARY Intrusive Memory Ratings: Item 4a. Duration of Interference	11; 12; 20; 8; 24; 15	—
SECONDARY Intrusive Memory Ratings: Distress (Item 2), Disruption to Concentration (Item 3), Interference (Item 4), Impact on Work Functioning (Item 5), and Impact on Functioning in Other Areas of Life (Item 7)	5.25; 5.46; 5.95; 5.17; 4.83; 4.16	—

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05616676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.