AzTrials
AzTrials

Intrusive Memories of Traumatic Event(s)GAINSNCT04992390

A Brief GAmeplay Intervention for NHS ICU Staff Affected by COVID-19 Trauma (GAINS Study)

A study testing Brief digital imagery-competing task intervention in people with Intrusive Memories of Traumatic Event(s), run by P1vital Products Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Intensive care unit (ICU) 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: these imagery-based memories can disrupt functioning and contribute… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Intrusive Memories of Traumatic Event(s)
What is being tested?
Brief digital imagery-competing task intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteUnited Kingdom
Study dates
24 Aug 2021to 30 Jun 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18 or above.
  • Able to read, write and speak in English.
  • Worked in a clinical role in an NHS Intensive Care Unit or equivalent during the COVID-19 pandemic (e.g. as a member of ICU staff or deployed to work in the ICU during the pandemic)
  • Experienced at least one traumatic event related to their work during the COVID-19 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.
Show all 9Show fewer
  • Have internet access.
  • Willing and able to provide informed consent and complete study procedures (including briefly listing their intrusive memories (without going into any detail), and playing the brief digital imagery-competing task with particular mental rotation instructions, and completing an online intrusive memory diary).
  • Willing and able to be contacted by the research team during the study period.

Who cannot join

  • Have fewer than three intrusive memories during the run-in week.
  • We will not exclude those undergoing other treatment for PTSD or its symptoms, so the study is as inclusive as possible to meet the challenges ICU staff are facing during the COVID-19 pandemic.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • P1vital Products Limited

    Wallingford, Oxfordshire, OX10 8BA

Other trials in United Kingdom

About this study

Official title: A Randomised Optimisation Study of a Brief Digital Imagery-competing Task Intervention to Support NHS ICU Staff Experiencing Intrusive Memories of Traumatic Events From Working in the COVID-19 Pandemic

Intensive care unit (ICU) 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: these imagery-based memories can disrupt functioning and contribute to posttraumatic 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 aim to optimise a brief digital intervention to help reduce the number of intrusive memories experienced by ICU staff (primary outcome). We will explore if it can improve work functioning and wellbeing (secondary outcomes). We will recruit approximately 150 ICU staff with intrusive memories of events experienced during the COVID-19 pandemic.

The study is funded by the Wellcome Trust (223016/Z/21/Z).

Read the detailed description

A statistical analysis plan was prepared prior to the first interim analysis for the outcomes that guided study optimisation, i.e., primarily the primary outcome.

A second statistical analysis plan was prepared prior to the end of the study, outlining the standard (frequentist) statistical approaches used to analyse the primary, secondary and tertiary data.

Regular monitoring 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.

Being tested
Brief digital imagery-competing task intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief digital imagery-competing task interventionBehavioural

    First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions.

    Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring).

Study groups in NCT04992390
Study groupRoleWhat they receive
Immediate intervention armExperimentalImmediate access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome).
Receives: Behavioral: Brief digital imagery-competing task intervention
Delayed intervention armExperimentalUsual care for 4 weeks including completing a daily count of the number of their intrusive memories in week 4 (primary outcome), followed by access to the brief digital imagery-competing task intervention plus symptom monitoring for 4 weeks.
Receives: Behavioral: Brief digital imagery-competing task intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 at week 4 (i.e., Day 22-28). To control for the number of intrusive memories recorded by participants in each experimental group during the run-in/screening week, we included the baseline count of intrusive memories (along with binary arm status) as fixed effect covariates in the Poisson regression model used for primary analysis.

    Measured: Week 4

Secondary outcomes (17)
  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.

    Total number of intrusive memories reported in Week 4 compared to run-in/screening week for the immediate intervention group and Week 8 compared to Week 4 for the delayed intervention group (i.e., within-group comparisons).

    Measured: Run-in/screening week (immediate intervention arm), week 4 (both arms) and week 8 (delayed intervention arm)

  2. Intrusive Memory Ratings, Ordinal Items

    The 9-item questionnaire assesses a number of intrusive memories characteristics. These characteristics include frequency (7-point categorical response from 'never' to 'many times a day); distress (0=not at all to 10=extremely); disruption to concentration (0=not at all to 10=extremely); interference with what you were doing (how much (0=not at all to 10=extremely) and for how long (6-point categorical response from '<1min' to '+60mins')); impact on work functioning (0=not at all to 10=extremely) and in what ways (open text response)); impact on functioning in other areas of life (how much (0= not at all to 10 = extremely) and in what ways (open text response)).

    Five quantitative outcomes are presented here. For two further ordinal items, frequency and duration of interference, please see below.

    Measured: Baseline, 4 weeks and 8 weeks

  3. Intrusive Memory Ratings, Frequency of Intrusive Memories Over Past Week

    The 9-item questionnaire assesses a number of intrusive memories characteristics. Five ordinal items are presented separately (see "Intrusive Memory Ratings, ordinal items"). Here we present one of the two categorical items. This item assesses the frequency of intrusive memories over the past week (7-point categorical response from 'never' to 'many times a day').

    Measured: Baseline, 4 weeks and 8 weeks

  4. Intrusive Memory Ratings, Duration of Interference

    The 9-item questionnaire assesses a number of intrusive memories characteristics. Five ordinal items are presented separately (see "Intrusive Memory Ratings, ordinal items"). Here we present one of the two categorical items. This item assesses the duration for which an intrusive memory interfered with with what participants were doing (6-point categorical response from '<1min' to '+60mins').

    Measured: Baseline, 4 weeks and 8 weeks

  5. Impact of Event Scale-Revised (IES-R)

    This 22-item questionnaire assesses subjective distress after a traumatic event (with reference to the events for which participants are taking part in the study).

    Items are rated for how distressing they have been during the past 7 days on a 5-point ordinal scale ranging from 0 ("not at all") to 4 ("extremely"). The measure consists of three subscales with subscale and total scores calculated as the mean of all items: intrusion subscale (8-items, score range 0-4), avoidance subscale (8-items, score range 0-4) and hyperarousal subscale (6-items, score range 0-4), and total score (all 22-items, score range 0-4). We will analyse total score as the mean of all 22-items, and subscales as the mean of items in each subscale separately. Higher scores indicate higher levels of subjective distress after a traumatic event.

    Measured: Baseline, 4 weeks and 8 weeks

  6. PTSD Checklist for DSM-5 (PCL-5) 4-item Version

    This shortened 4-item version of the PCL-5 assesses symptoms of PTSD over the last month.

    Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total score ranges from 0 to 16 (cut-off for possible PTSD is 10 or above).

    Measured: Baseline, 4 weeks and 8 weeks

  7. Sleep Condition Indicator (SCI)

    This 8-item scale measures sleep problems against the DSM-5 criteria for insomnia disorder.

    Item responses are each scored 0-4, with scores from 0 to 2 indicating threshold criteria for insomnia disorder. Total score ranges 0-32, with a higher score indicating better sleep (cut-off for possible insomnia disorder is a total score from 0 to 2).

    Measured: Baseline, 4 weeks and 8 weeks

  8. Generalised Anxiety Disorder 2-item Scale (GAD-2)

    Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible GAD is 3 or above).

    Measured: Baseline, 4 weeks and 8 weeks

  9. Patient Health Questionnaire 2-item Version (PHQ-2)

    This 2-item short-form self-report measure assesses symptoms of depression.

    Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day"). Total score is the sum of both items and ranges from 0 to 6 (cut-off for possible major depressive disorder is 3 or above).

    Measured: Baseline, 4 weeks and 8 weeks

  10. Psychological Outcome Profiles (PSYCHLOPS)

    This measure consists of 4 questions that are scored and designed to assess the impact of a person's intrusive memories.

    Questions 1b, 2b, 3b, and 4 are scored. These have a six-point ordinal scale ranging from 0 to 5 and are summed to generate a total score from 0 to 20. Higher values indicate the person is more severely affected.

    Measured: Baseline, 4 weeks and 8 weeks

  11. World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0)

    The 12-item, self-report version of the WHODAS 2.0 will be used to assess difficulties in relation to the impact of intrusive memories.

    Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 (none) to 4 (extreme or cannot do). The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points).

    Measured: Baseline, 4 weeks and 8 weeks

  12. 5-level European Quality of Life 5 Dimension (EQ-5D-5L)

    The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief measure for assessing general quality of life and health status.

    Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale. 5 items are scored on a 5-point ordinal scale from 'no problem' (1) to 'highest level of problems' (5). Respondents also self-rate their overall health today on a visual analogue scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine). Scores are analysed separately (not summed).

    Here we present the 'overall health' visual analogue scale item.

    Measured: Baseline, 4 weeks and 8 weeks

  13. Scale of Work Engagement and Burnout (SWEBO)

    This 19-item self-report measure assesses work engagement and burnout. Respondents rate how often they have felt each descriptive item in the past two weeks, from 1 (not at all) to 4 (all the time).

    The work engagement subscale consists of 10-items assessing three dimensions (attentiveness, vigour, and dedication) with each dimension consisting of 4-, 3-, and 3-items respectively. Greater scores indicate a higher (i.e., better) degree of work engagement.

    The burnout subscale consists of 9-items assessing three dimensions (Engagement, Exhaustion, and Disengagement), with each dimension consisting of 3-items. Greater scores indicate a higher (i.e., functionally worse) degree of burnout.

    A mean score is calculated for the work engagement and burnout subscales, from individual items (for both subscales, scores range 1-4).

    Measured: Time Frame: Baseline, 4 weeks and 8 weeks

  14. Sickness Absence

    Single item assessing self-reported number of sick days taken from work in the last 4 weeks. Total scoring includes total number of sick days.

    Measured: Baseline, 4 weeks and 8 weeks

  15. Intention to Leave Job

    This 3 items questionnaire is used to assess participants' intention to leave their job e.g. "I think a lot about leaving the job", each rated from 1 (strongly agree) to 5 (strongly disagree). The total score ranges 3 to 15, with a lower score indicating stronger intention to leave the job.

    Measured: Baseline, 4 weeks and 8 weeks

  16. Weekly Work Pattern, Number of Days Worked

    One item asses the number of days worked in the last week (both with responses from 0 to 7 days).

    Measured: Baseline, 4 weeks and 8 weeks

  17. Weekly Work Pattern, Number of Night Shifts Worked

    One item asses the number of night shifts worked in the last week (both with responses from 0 to 7).

    Measured: Baseline, 4 weeks and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start24 Aug 2021
  3. Primary completion30 May 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04992390
Sponsor's protocol ID
P1V-GAINS-IN01
Acronym
GAINS
Status last verified
Jun 2025
First submitted
2 Aug 2021
Last updated
17 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: An anonymised database of individual participant data, along with a data dictionary, as well as the Clinical Study Report (which will include summarised anonymised participant data), will be shared on the Open Science Framework.

Publications

  • Iyadurai L, Highfield J, Kanstrup M, Markham A, Ramineni V, Guo B, Jaki T, Kingslake J, Goodwin GM, Summers C, Bonsall MB, Holmes EA. Reducing intrusive memories after trauma via an imagery-competing task intervention in COVID-19 intensive care staff: a randomised controlled trial. Transl Psychiatry. 2023 Sep 1;13(1):290. doi: 10.1038/s41398-023-02578-0.

    PubMed 37658043
  • Ramineni V, Millroth P, Iyadurai L, Jaki T, Kingslake J, Highfield J, Summers C, Bonsall MB, Holmes EA. Treating intrusive memories after trauma in healthcare workers: a Bayesian adaptive randomised trial developing an imagery-competing task intervention. Mol Psychiatry. 2023 Jul;28(7):2985-2994. doi: 10.1038/s41380-023-02062-7. Epub 2023 Apr 26.

    PubMed 37100869

Questions about this trial

What is this clinical trial studying?

A study testing Brief digital imagery-competing task intervention in people with Intrusive Memories of Traumatic Event(s), run by P1vital Products Limited at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Intrusive Memories of Traumatic Event(s) (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04992390, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in