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Intrusive Memories of Traumatic Event(s)GAINS-2NCT05616676

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

A study testing Brief digital imagery-competing task, Brief digital music-listening task and Treatment As Usual 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
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Trial 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… 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, Brief digital music-listening task and Treatment As Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteUnited Kingdom
Study dates
8 Dec 2022to 19 Mar 2024
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 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.
Show all 10Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • P1vital Products Ltd

    Wallingford, Oxfordshire, OX10 8BA

Other trials in United Kingdom

About this study

Official title: 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.

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).

Read the 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.

Being tested
Brief digital imagery-competing task, Brief digital music-listening task, Treatment As Usual

What participants receive

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

  • Brief digital imagery-competing taskBehavioural

    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 taskBehavioural

    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 UsualOther

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

Study groups in NCT05616676
Study groupRoleWhat they receive
Brief digital imagery-competing taskExperimentalAccess to a brief digital imagery-competing task for 24 weeks (first 4 weeks with optional researcher support).
Receives: Behavioral: Brief digital imagery-competing task
Brief digital music-listening taskExperimentalAccess to a brief digital music-listening task for 24 weeks (first 4 weeks with optional researcher support).
Receives: Behavioral: Brief digital music-listening task
Treatment As UsualExperimentalAccess to routine care that participants would otherwise receive if having intrusive memories of traumatic events for 24 weeks.
Receives: Other: Treatment As Usual

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.

    Measured: Run-in/screening week, Week 4 (all arms)

Secondary outcomes (19)

  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.

    Measured: Run-in/Screening week, Weeks 12 and 24 (all arms)

  2. PTSD Checklist for DSM-5 (PCL-5)

    This 20-item measure assesses symptoms of PTSD over the last week. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Scores are summed to give a total severity score (ranging 0 to 80), with greater scores indicating greater symptom severity.

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

  3. Sleep Condition Indicator (SCI)

    This 2-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 0-8, with a higher score indicating better sleep.

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

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

    This 2-item short-form self-report measure assesses symptoms of anxiety. 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, with greater scores indicating greater symptom severity.

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

  5. 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, with greater scores indicating greater symptom severity.

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

  6. Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Total Score

    This 19-item self-report measure assesses work engagement and burnout. The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication). The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness). Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time). The work engagement subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work engagement.

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

  7. Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Total Score

    This 19-item self-report measure assesses work engagement and burnout. The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication). The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness). Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time). The work burnout subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work burnout.

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

  8. Sickness Absence

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

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

  9. Intention to Leave Job

    3 items 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, 12 weeks and 24 weeks (all arms)

  10. 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Mobility

    The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The mobility item is scored on a 5-point ordinal scale from "I have no problems in walking about" to "I am unable to walk about".

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

  11. 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Self Care

    The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The self care item is scored on a 5-point ordinal scale from "I have no problems washing or dressing myself" to "I am unable to wash or dress myself".

    Measured: Baseline, Week 4, Week 12 and Week 24

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

    The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The usual activities item is scored on a 5-point ordinal scale from "I have no problems doing my usual activities" to "I am unable to do my usual activities".

    Measured: Baseline, Week 4, Week 12 and Week 24

  13. 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Pain / Discomfort

    The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The pain / discomfort item is scored on a 5-point ordinal scale from "I have no pain or discomfort" to "I have extreme pain or discomfort".

    Measured: Baseline, Week 4, Week 12 and Week 24

  14. 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Anxiety / Depression

    The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item 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. The anxiety / depression item is scored on a 5-point ordinal scale from "I am not anxious or depressed" to "I am extremely anxious or depressed".

    Measured: Baseline, Week 4, Week 12 and Week 24

  15. 5-level European Quality of Life 5 Dimension (EQ-5D-5L), Overall Health

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

    Measured: Baseline, Week 4, Week 12 and Week 24

  16. 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), with greater scores indicating greater impairment.

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

  17. Intrusive Memory Ratings: Item 1. Approximately How Often Did Intrusive Memories of the Traumatic Event Pop Into Your Mind?

    This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)).

    Here we present Item 1 assessing the frequency of intrusive memories on a 7-point scale from 'never' to 'many times a day'. Other items from this questionnaire are presented below.

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

  18. Intrusive Memory Ratings: Item 4a. Duration of Interference

    This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)).

    Here we present Item 4a assessing the for how long intrusive memories interfered with what participants were doing on a 7-point scale from '<1 min' to '>60 mins'. Other items from this questionnaire are presented below.

    Measured: Baseline, Week 4, Week 12 and Week 24 (all arms)

  19. 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)

    This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)).

    Here we present data for the five items scored on an 11-point scale (0=not at all to 10=extremely) assessing 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).

    Measured: Baseline, Week 4, Week 12 and Week 24 (all arms)

Timeline

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

  1. First posted15 Nov 2022
  2. Study start8 Dec 2022
  3. Primary completion30 Oct 2023
  4. Study completion19 Mar 2024

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
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05616676
Sponsor's protocol ID
P1V-GAINS-IN02
Acronym
GAINS-2
Status last verified
Apr 2026
First submitted
11 Nov 2022
Last updated
27 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Study Protocol and Statistical Analysis Plan will be shared on the Open Science Framework, together with an anonymised database of individual participant data, data dictionary, and analysis scripts.

Publications

  • Beckenstrom AC, Bonsall MB, Markham A, Slade O, Ramineni V, Iyadurai L, Islam Z, Highfield J, Jaki T, Goodwin GM, Dias R, Daniels R, Malik A, Summers C, Kingslake J, Holmes EA. A digital imagery-competing task intervention for stopping intrusive memories in trauma-exposed health-care staff during the COVID-19 pandemic in the UK: a Bayesian adaptive randomised clinical trial. Lancet Psychiatry. 2026 Mar;13(3):233-247. doi: 10.1016/S2215-0366(25)00397-9.

    PubMed 41720573

Questions about this trial

What is this clinical trial studying?

A study testing Brief digital imagery-competing task, Brief digital music-listening task and Treatment As Usual 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 10 inclusion and 1 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 27 May 2026. 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 27 May 2026). 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: Run-in/screening week, Week 4 (all arms)). 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 NCT05616676, which also lists 1 linked publication.

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 27 May 2026.

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