Un breve intervento di compito cognitivo per il personale del NHS affetto da trauma da COVID-19 (studio GAINS-2) (GAINS-2)
Una prova controllata randomizzata di un breve intervento di compito cognitivo per supportare il personale del NHS che vive ricordi intrusivi di eventi traumatici dal lavoro nella pandemia COVID-19.
Il personale sanitario in prima linea è spesso esposto a eventi traumatici sul lavoro (ad esempio, assistere alla morte di pazienti), amplificati dalla pandemia di COVID-19. Una parte significativa sperimenta ricordi intrusivi di questi eventi che vengono improvvisamente in mente: possono interrompere il funzionamento e possono contribuire al disturbo da stress post-traumatico. Precedenti ricerche hanno dimostrato che un breve intervento comportamentale può ridurre il numero di ricordi intrusivi dopo un evento traumatico. In questo studio testeremo l'effetto di un compito di competizione di immagini digitali, un compito di ascolto di musica digitale e trattamento come al solito (TAU) per il personale del Servizio Sanitario Nazionale (NHS) con ricordi intrusivi di eventi traumatici legati al lavoro dalla pandemia. Testiamo l'effetto sul numero di ricordi intrusivi (risultato primario) e altri sintomi clinici (PTSD, ansia, depressione e insonnia), oltre al funzionamento lavorativo, al funzionamento generale e alla qualità della vita (risultati secondari). Verranno inoltre esplorate la fattibilità, l'accettabilità e l'attuazione dell'intervento (ulteriori risultati). Recluteremo circa 150 dipendenti del NHS (tramite la Intensive Care Society, i social media e la pubblicità diretta da NHS Trusts) con ricordi intrusivi di eventi traumatici vissuti durante la pandemia di COVID-19.
Lo studio è finanziato dal Wellcome Trust (223016/Z/21/Z).
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Un piano di analisi statistica sarà preparato prima della prima analisi ad interim utilizzando l'analisi bayesiana per l'inferenza statistica.
I prodotti P1vital eseguiranno un monitoraggio regolare per verificare che lo studio sia condotto e che i dati siano generati, documentati e riportati in conformità con il protocollo, la GCP e i requisiti normativi applicabili. I rappresentanti dell'assicurazione della qualità dello sponsor possono effettuare un audit dello studio in conformità con le linee guida normative e le relative procedure operative standard.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Oxfordshire
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Wallingford, Oxfordshire, Regno Unito, OX10 8BA
- P1vital Products Ltd
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Descrizione
Criterio di inclusione:
- A partire dai 18 anni.
- In grado di leggere, scrivere e parlare in inglese.
- Ha lavorato in un ruolo clinico con pazienti COVID-19 nel NHS durante la pandemia COVID-19.
- Ha vissuto almeno un evento traumatico correlato al proprio lavoro clinico durante la pandemia di COVID-9 che soddisfa il criterio A del Manuale diagnostico e statistico dei disturbi mentali, 5a edizione (DSM-5) criteri per il disturbo da stress post-traumatico (PTSD): "esposizione a morte effettiva o minacciata, lesioni gravi o violenza sessuale" "vivendo direttamente l'evento/i traumatico/i" o "assistendo, di persona, all'evento/i così come si è verificato ad altri".
- Sperimenta ricordi intrusivi dell'evento/i traumatico/i.
- Ha sperimentato almeno tre ricordi intrusivi nella settimana prima dello screening.
- Avere accesso a Internet.
- Disponibilità e capacità di fornire il consenso informato e le procedure di studio complete
- Disponibilità e capacità di essere contattato dal gruppo di ricerca durante il periodo di studio.
- Non hanno preso parte a uno studio precedente di questo intervento da parte di questo gruppo di ricerca
Criteri di esclusione:
• Avere meno di tre ricordi intrusivi durante la settimana di rodaggio.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Breve compito in competizione con le immagini digitali
Accesso a un breve compito di competizione di immagini digitali per 24 settimane (prime 4 settimane con supporto opzionale del ricercatore).
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Prima sessione guidata da un ricercatore: un segnale di memoria seguito da un gioco per computer con istruzioni di rotazione mentale. Possibilità di partecipare a sessioni autogestite/guidate dopo la prima sessione. |
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Sperimentale: Breve compito di ascolto di musica digitale
Accesso a un breve compito di ascolto di musica digitale per 24 settimane (prime 4 settimane con supporto opzionale del ricercatore).
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Prima sessione guidata da un ricercatore: Informazioni sulla musica del compositore seguite dall'ascolto di musica classica. Possibilità di partecipare a sessioni autogestite/guidate dopo la prima sessione. |
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Sperimentale: Trattamento come al solito
Accesso alle cure di routine che i partecipanti riceverebbero altrimenti se avessero ricordi intrusivi di eventi traumatici per 24 settimane.
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Accesso alle cure di routine che i partecipanti riceverebbero altrimenti se avessero ricordi intrusivi di eventi traumatici.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Intrusive Memories of Traumatic Event(s)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Indicatore delle condizioni del sonno (SCI)
Lasso di tempo: Basale, 4 settimane, 12 settimane e 24 settimane (tutti i bracci)
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Questa scala a 2 item misura i problemi del sonno rispetto ai criteri del DSM-5 per il disturbo dell'insonnia.
Ciascuna risposta agli item ha un punteggio da 0 a 4, con punteggi da 0 a 2 che indicano criteri di soglia per il disturbo di insonnia.
Il punteggio totale varia da 0 a 8, con un punteggio più alto che indica un sonno migliore.
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Basale, 4 settimane, 12 settimane e 24 settimane (tutti i bracci)
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Number of Intrusive Memories of Traumatic Event(s)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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?
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Changes to Health and Work - Dichotomous Outcomes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: Emily Holmes, Uppsala University (UU), Sweden
- Investigatore principale: Amy Beckenstrom, P1vital Products, Wallingford
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P1V-GAINS-IN02
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
I dati di ricerca resi anonimi saranno resi disponibili sull'OSF a tempo indeterminato.
OSF è un'applicazione web open source liberamente accessibile al pubblico e alla comunità scientifica.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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