P1vital Products Ltd
Wallingford, Oxfordshire, OX10 8BA, United Kingdom
NCT Number: NCT05616676
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Wallingford, Oxfordshire, OX10 8BA, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Access to routine care that participants would otherwise receive if having intrusive memories of traumatic events.
Time frame: Run-in/screening week, Week 4 (all arms)
Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
Time frame: Run-in/Screening week, Weeks 12 and 24 (all arms)
Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
Single item assessing self-reported number of sick days taken from work in the last 4 weeks.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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".
Time frame: Baseline, Week 4, Week 12 and Week 24
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".
Time frame: Baseline, Week 4, Week 12 and Week 24
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".
Time frame: Baseline, Week 4, Week 12 and Week 24
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".
Time frame: Baseline, Week 4, Week 12 and Week 24
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".
Time frame: Baseline, Week 4, Week 12 and Week 24
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).
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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.
Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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.
Time frame: Baseline, Week 4, Week 12 and Week 24 (all arms)
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.
Time frame: Baseline, Week 4, Week 12 and Week 24 (all arms)
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).
Time frame: 4 weeks, 12 weeks and 24 weeks (all arms)
The 9-item questionnaire will be used to assess the occurrence and number of any new traumatic events, any additional stressful life events (e.g. relationship problems, financial problems), new treatments received, untoward medical occurrences, changes to the job, or changes to the number of hours worked per week since the last assessment. Dichotomous outcomes are presented below, and discrete outcomes with count data are presented under "Changes to health and work - discrete outcomes".
Time frame: 4 weeks, 12 weeks and 24 weeks (all arms)
The 9-item questionnaire will be used to assess the occurrence and number of any new traumatic events, any additional stressful life events (e.g. relationship problems, financial problems), new treatments received, untoward medical occurrences, changes to the job, or changes to the number of hours worked per week since the last assessment. Discrete outcomes are presented below, and dichotomous outcomes are presented under "Changes to health and work - dichotomous outcomes".
Time frame: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
A 12-item questionnaire assessing participants' experience of using the brief cognitive task. The first ten items assess how easy, helpful, distressing, burdensome and acceptable participants found the brief cognitive task, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within the NHS, each rated from 0 (not at all) to 10 (very). The last two items ask how the brief cognitive task could be improved, and for any other comments or suggestions about the brief cogntive task, both with an open response.
Time frame: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
A 12-item questionnaire assessing participants' experience of using the brief cognitive task. The first ten items assess how easy, helpful, distressing, burdensome and acceptable participants found the brief cognitive task, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within the NHS, each rated from 0 (not at all) to 10 (very); items for distress and burden are reverse scored from 0 (very) to 10 (not at all). The last two items ask how the brief cognitive task could be improved, and for any other comments or suggestions about the brief cognitive task, both with an open response. A total score of the eight categorical items is presented (range 0 - 80), with greater scores indicating more favourable feedback towards the allocated digital task.
Time frame: Week 4 and Week 24 (brief imagery competing task and brief music listening task arms only)
This semi-structured interview will consist of a number of questions designed to gain an in-depth understanding of participants' experience of using the brief cognitive task, including acceptability, improvement suggestions, and potential barriers/facilitators to implementation.
Time frame: Baseline, Week 4, Week 12 and Week 24
One item asses the number of days worked in the last week (both with responses from 0 to 7 days).
Time frame: Baseline, Week 4, Week 12 and Week 24
One item asses the number of night shifts worked in the last week (both with responses from 0 to 7).
Time frame: Day 0 (post-randomisation)
The Credibility and Expectancy Questionnaire (CEQ) consists of 6 items. Items 1, 2, 3, and 5 were assessed on a 9-point integer scale ranging from 1 ("not at all") to 9 ("very"). Items 4 and 6 were assessed on an 11-point scale (response range of 0-100%) and, for comparability, were converted to the same 9-point scale as other items. CEQ total score was calculated by summing all six items producing a possible total score range of 6-54; with greater scores indicating greater credibility and expectancy of intervention effect. Participants completed the Credibility and Expectancy Questionnaire (CEQ) after being informed of treatment allocation (Day 0).
Time frame: Day 0 (post-randomisation)
The Credibility and Expectancy Questionnaire (CEQ) consists of 6 items. Items 1, 2, 3, and 5 were assessed on a 9-point integer scale ranging from 1 ("not at all") to 9 ("very"). Items 4 and 6 were assessed on an 11-point scale (response range of 0-100%) and, for comparability, were converted to the same 9-point scale as other items. CEQ total score was calculated by summing all six items producing a possible total score range of 6-54; with greater scores indicating greater credibility and expectancy of intervention effect. Participants completed the Credibility and Expectancy Questionnaire (CEQ) after being informed of treatment allocation (Day 0).
P1vital Products Limited
Industry
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.
Acronym: GAINS-2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04992390
Intrusive Memories of Traumatic Event(s)
Wallingford, Oxfordshire, United Kingdom
View Trial DetailsNCT05089058
Intrusive Memories of Traumatic Event(s)
Reykjavik, Iceland
View Trial DetailsNCT04460014
Intrusive Memories of Traumatic Event(s), Mental Disorders
Huddinge, Sweden
View Trial DetailsNCT05849337
Intrusive Memories of Traumatic Event(s)
Reykjavik, Iceland
View Trial Details