En kort kognitiv oppgaveintervensjon for NHS-ansatte berørt av COVID-19-trauma (GAINS-2-studie) (GAINS-2)
En randomisert kontrollert utprøving av en kort kognitiv oppgaveintervensjon for å støtte NHS-ansatte som opplever påtrengende minner om traumatiske hendelser fra arbeid i COVID-19-pandemien.
Helsepersonell i frontlinjen blir ofte utsatt for traumatiske hendelser på jobben (f.eks. å være vitne til at pasienter dør), forsterket av COVID-19-pandemien. En betydelig andel opplever påtrengende minner om disse hendelsene som plutselig dukker opp i tankene: de kan forstyrre funksjonen og kan bidra til posttraumatisk stresslidelse. Tidligere forskning har vist at en kort atferdsintervensjon kan redusere antall påtrengende minner etter en traumatisk hendelse. I denne studien vil vi teste effekten av en digital bildekonkurrerende oppgave, en digital musikklyttingsoppgave og behandling som vanlig (TAU) for National Health Service (NHS) ansatte med påtrengende minner om arbeidsrelaterte traumatiske hendelser fra pandemien. Vi tester effekten på antall påtrengende minner (primært utfall), og andre kliniske symptomer (PTSD, angst, depresjon og søvnløshet), i tillegg til arbeidsfunksjon, generell funksjon og livskvalitet (sekundære utfall). Intervensjonsmulighet, akseptabilitet og implementering vil også bli undersøkt (ytterligere utfall). Vi vil rekruttere omtrent 150 NHS-ansatte (via Intensive Care Society, sosiale medier og direkte annonsering fra NHS Trusts) med påtrengende minner om traumatiske hendelser opplevd under COVID-19-pandemien.
Studien er finansiert av Wellcome Trust (223016/Z/21/Z).
Studieoversikt
Status
Detaljert beskrivelse
En statistisk analyseplan vil bli utarbeidet før den første interimanalysen ved bruk av Bayesianske analyser for statistisk slutning.
Regelmessig overvåking vil bli utført av P1vital Products for å bekrefte at studien er utført, og data genereres, dokumenteres og rapporteres i samsvar med protokollen, GCP og gjeldende regulatoriske krav. Kvalitetssikringsrepresentanter fra sponsoren kan gjennomføre en revisjon av studien i samsvar med regulatoriske retningslinjer og relevante standard driftsprosedyrer.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Oxfordshire
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Wallingford, Oxfordshire, Storbritannia, OX10 8BA
- P1vital Products Ltd
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- 18 år eller eldre.
- Kunne lese, skrive og snakke på engelsk.
- Jobbet i en klinisk rolle med COVID-19-pasienter i NHS under COVID-19-pandemien.
- Opplevde minst én traumatisk hendelse relatert til deres kliniske arbeid under COVID-9-pandemien som møtte kriterium A i Diagnostic and Statistical Manual of Mental Disorders, 5. utgave (DSM-5) kriterier for posttraumatisk stresslidelse (PTSD): "eksponering" til faktisk eller truet død, alvorlig skade eller seksuell vold" ved å "direkte oppleve den(e) traumatiske hendelsen(e)" eller "være personlig vitne til hendelsen(e) slik den skjedde for andre".
- Opplev påtrengende minner fra den(e) traumatiske hendelsen(e).
- Opplevde minst tre påtrengende minner i uken før visningen.
- Har internettilgang.
- Villig og i stand til å gi informert samtykke og komplette studieprosedyrer
- Villig og i stand til å bli kontaktet av forskerteamet i studieperioden.
- Har ikke deltatt i en tidligere studie av denne intervensjonen fra dette forskerteamet
Ekskluderingskriterier:
• Ha færre enn tre påtrengende minner i løpet av innkjøringsuken.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Kort oppgave som konkurrerer med digitale bilder
Tilgang til en kort digital bildekonkurrerende oppgave i 24 uker (de første 4 ukene med valgfri forskerstøtte).
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Første økt guidet av en forsker: Et minneord etterfulgt av å spille et dataspill med mental rotasjonsinstruksjoner. Mulighet for å delta i selvadministrerte/veiledede økter etter første økt. |
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Eksperimentell: Kort digital musikklytteoppgave
Tilgang til en kort digital musikklytteoppgave i 24 uker (de første 4 ukene med valgfri forskerstøtte).
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Første økt ledet av en forsker: Informasjon om komponistens musikk etterfulgt av lytting til klassisk musikk. Mulighet for å delta i selvadministrerte/veiledede økter etter første økt. |
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Eksperimentell: Behandling som vanlig
Tilgang til rutinemessig behandling som deltakerne ellers ville fått dersom de hadde påtrengende minner om traumatiske hendelser i 24 uker.
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Tilgang til rutinemessig omsorg som deltakere ellers ville fått hvis de har påtrengende minner om traumatiske hendelser.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Intrusive Memories of Traumatic Event(s)
Tidsramme: Run-in/screening week, Week 4 (all arms)
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Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
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Run-in/screening week, Week 4 (all arms)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Søvntilstandsindikator (SCI)
Tidsramme: Baseline, 4 uker, 12 uker og 24 uker (alle armer)
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Denne todelte skalaen måler søvnproblemer i forhold til DSM-5-kriteriene for søvnløshet.
Vareresponser er hver skåret 0-4, med skårer fra 0 til 2 som indikerer terskelkriterier for søvnløshet.
Total poengsum varierer fra 0-8, med en høyere poengsum som indikerer bedre søvn.
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Baseline, 4 uker, 12 uker og 24 uker (alle armer)
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Number of Intrusive Memories of Traumatic Event(s)
Tidsramme: Run-in/Screening week, Weeks 12 and 24 (all arms)
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Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
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Run-in/Screening week, Weeks 12 and 24 (all arms)
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PTSD Checklist for DSM-5 (PCL-5)
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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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.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Generalised Anxiety Disorder 2-item Scale (GAD-2)
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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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.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Patient Health Questionnaire 2-item Version (PHQ-2)
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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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.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Total Score
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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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.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Total Score
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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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.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Sickness Absence
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Single item assessing self-reported number of sick days taken from work in the last 4 weeks.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Intention to Leave Job
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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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.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Mobility
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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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".
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Self Care
Tidsramme: Baseline, Week 4, Week 12 and Week 24
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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".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Usual Activities
Tidsramme: Baseline, Week 4, Week 12 and Week 24
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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".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Pain / Discomfort
Tidsramme: Baseline, Week 4, Week 12 and Week 24
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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".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Anxiety / Depression
Tidsramme: Baseline, Week 4, Week 12 and Week 24
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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".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Overall Health
Tidsramme: Baseline, Week 4, Week 12 and Week 24
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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).
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Baseline, Week 4, Week 12 and Week 24
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World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0)
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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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.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Intrusive Memory Ratings: Item 1. Approximately How Often Did Intrusive Memories of the Traumatic Event Pop Into Your Mind?
Tidsramme: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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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. |
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Intrusive Memory Ratings: Item 4a. Duration of Interference
Tidsramme: Baseline, Week 4, Week 12 and Week 24 (all arms)
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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. |
Baseline, Week 4, Week 12 and Week 24 (all arms)
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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)
Tidsramme: Baseline, Week 4, Week 12 and Week 24 (all arms)
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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). |
Baseline, Week 4, Week 12 and Week 24 (all arms)
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Changes to Health and Work - Dichotomous Outcomes
Tidsramme: 4 weeks, 12 weeks and 24 weeks (all arms)
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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".
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4 weeks, 12 weeks and 24 weeks (all arms)
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Changes to Health and Work - Discrete Outcomes
Tidsramme: 4 weeks, 12 weeks and 24 weeks (all arms)
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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".
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4 weeks, 12 weeks and 24 weeks (all arms)
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Feedback Questionnaire
Tidsramme: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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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.
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After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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Feedback Questionnaire (Total Score)
Tidsramme: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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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.
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After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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Optional Qualitative Interview
Tidsramme: Week 4 and Week 24 (brief imagery competing task and brief music listening task arms only)
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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.
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Week 4 and Week 24 (brief imagery competing task and brief music listening task arms only)
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Weekly Work Pattern, Number of Days Worked
Tidsramme: Baseline, Week 4, Week 12 and Week 24
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One item asses the number of days worked in the last week (both with responses from 0 to 7 days).
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Baseline, Week 4, Week 12 and Week 24
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Weekly Work Pattern, Number of Night Shifts Worked
Tidsramme: Baseline, Week 4, Week 12 and Week 24
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One item asses the number of night shifts worked in the last week (both with responses from 0 to 7).
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Baseline, Week 4, Week 12 and Week 24
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Expectancy of Intervention Effect (Credibility and Expectancy Questionnaire, CEQ) - Categorical Items
Tidsramme: Day 0 (post-randomisation)
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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).
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Day 0 (post-randomisation)
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Expectancy of Intervention Effect (Credibility and Expectancy Questionnaire, CEQ) - Total Score
Tidsramme: Day 0 (post-randomisation)
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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).
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Day 0 (post-randomisation)
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Emily Holmes, Uppsala University (UU), Sweden
- Hovedetterforsker: Amy Beckenstrom, P1vital Products, Wallingford
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P1V-GAINS-IN02
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
Anonymiserte forskningsdata vil bli gjort tilgjengelig på OSF på ubestemt tid.
OSF er en åpen kildekode-nettapplikasjon som er fritt tilgjengelig for offentligheten og det vitenskapelige samfunnet.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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