Trial Outcomes & Findings for A Brief Cognitive Task Intervention for NHS Staff Affected by COVID-19 Trauma (GAINS-2 Study) (NCT NCT05616676)

Between 08 December 2022 and 15 September 2023, 176 participants were screened via online questionnaires, with 122 eligible participants subsequently providing informed consent and commencing the run-in/screening week.

Prior to randomisation, nine participants were excluded for having fewer than three IMs in the baseline IM diary, eight were lost to follow-up, and six withdrew prior to randomisation. These participants are detailed in the 'Run-in week only (non-randomised)' arm in the Participant Flow.

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

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

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

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.

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.

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.

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.

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.

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.

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

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.

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".

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".

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".

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".

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".

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).

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.

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.

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.

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).

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".

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".

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.

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.

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.

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

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

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).

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).