Uma breve intervenção cognitiva em tarefas para funcionários do NHS afetados por trauma de COVID-19 (estudo GAINS-2) (GAINS-2)
Um ensaio controlado randomizado de uma intervenção breve de tarefa cognitiva para apoiar a equipe do NHS que experimenta memórias intrusivas de eventos traumáticos do trabalho na pandemia de COVID-19.
A equipe de saúde da linha de frente é frequentemente exposta a eventos traumáticos no trabalho (por exemplo, testemunhar a morte de pacientes), amplificados pela pandemia de COVID-19. Uma proporção significativa experimenta memórias intrusivas desses eventos que surgem repentinamente na mente: eles podem interromper o funcionamento e contribuir para o transtorno de estresse pós-traumático. Pesquisas anteriores mostraram que uma breve intervenção comportamental pode reduzir o número de memórias intrusivas após um evento traumático. Neste estudo, testaremos o efeito de uma tarefa de competição de imagens digitais, uma tarefa de audição de música digital e tratamento usual (TAU) para funcionários do Serviço Nacional de Saúde (NHS) com memórias intrusivas de eventos traumáticos relacionados ao trabalho da pandemia. Testamos o efeito no número de memórias intrusivas (desfecho primário) e outros sintomas clínicos (TEPT, ansiedade, depressão e insônia), além do funcionamento no trabalho, funcionamento geral e qualidade de vida (desfechos secundários). A viabilidade, aceitabilidade e implementação da intervenção também serão exploradas (resultados adicionais). Recrutaremos aproximadamente 150 funcionários do NHS (por meio da Intensive Care Society, mídia social e publicidade direta do NHS Trusts) com memórias intrusivas de eventos traumáticos vivenciados durante a pandemia de COVID-19.
O estudo é financiado pelo Wellcome Trust (223016/Z/21/Z).
Visão geral do estudo
Status
Descrição detalhada
Um plano de análise estatística será preparado antes da primeira análise interina usando análises bayesianas para inferência estatística.
O monitoramento regular será realizado pela P1vital Products para verificar se o estudo é conduzido e os dados são gerados, documentados e relatados em conformidade com o protocolo, GCP e os requisitos regulatórios aplicáveis. Os representantes de garantia de qualidade do Patrocinador podem realizar uma auditoria do estudo em conformidade com as diretrizes regulamentares e os procedimentos operacionais padrão relevantes.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Oxfordshire
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Wallingford, Oxfordshire, Reino Unido, OX10 8BA
- P1vital Products Ltd
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
Critério de inclusão:
- Maiores de 18 anos ou mais.
- Capaz de ler, escrever e falar em inglês.
- Trabalhou em uma função clínica com pacientes com COVID-19 no NHS durante a pandemia de COVID-19.
- Experimentou pelo menos um evento traumático relacionado ao seu trabalho clínico durante a pandemia de COVID-9 atendendo ao critério A do Manual Diagnóstico e Estatístico de Transtornos Mentais, 5ª edição (DSM-5) critérios para Transtorno de Estresse Pós-Traumático (TEPT): "exposição morte real ou ameaçada, ferimentos graves ou violência sexual" por "experimentar diretamente o(s) evento(s) traumático(s)" ou "testemunhar, pessoalmente, o(s) evento(s) como ocorreu com outras pessoas".
- Experimente memórias intrusivas do(s) evento(s) traumático(s).
- Experimentou pelo menos três memórias intrusivas na semana anterior à triagem.
- Tenha acesso à internet.
- Disposto e capaz de fornecer consentimento informado e concluir os procedimentos do estudo
- Disposto e capaz de ser contatado pela equipe de pesquisa durante o período do estudo.
- Não ter participado de um estudo anterior desta intervenção desta equipe de pesquisa
Critério de exclusão:
• Ter menos de três memórias intrusivas durante a semana inicial.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Tarefa breve de competição de imagens digitais
Acesso a uma breve tarefa de competição de imagens digitais por 24 semanas (primeiras 4 semanas com suporte opcional do pesquisador).
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Primeira sessão guiada por um pesquisador: Uma dica de memória seguida de um jogo de computador com instruções de rotação mental. Opção de participar de sessões autoadministradas/guiadas após a primeira sessão. |
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Experimental: Tarefa breve de ouvir música digital
Acesso a uma breve tarefa de audição de música digital por 24 semanas (primeiras 4 semanas com suporte de pesquisador opcional).
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Primeira sessão orientada por um investigador: Informação sobre a música do compositor seguida de audição de música clássica. Opção de participar de sessões autoadministradas/guiadas após a primeira sessão. |
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Experimental: Tratamento como de costume
Acesso a cuidados de rotina que os participantes receberiam caso tivessem memórias intrusivas de eventos traumáticos por 24 semanas.
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Acesso a cuidados de rotina que os participantes receberiam caso tivessem memórias intrusivas de eventos traumáticos.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Intrusive Memories of Traumatic Event(s)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Indicador de condição de sono (SCI)
Prazo: Linha de base, 4 semanas, 12 semanas e 24 semanas (todos os braços)
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Esta escala de 2 itens mede os problemas do sono em relação aos critérios do DSM-5 para transtorno de insônia.
Cada resposta aos itens é pontuada de 0 a 4, com pontuações de 0 a 2 indicando critérios limiares para transtorno de insônia.
A pontuação total varia de 0 a 8, sendo que uma pontuação mais alta indica um sono melhor.
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Linha de base, 4 semanas, 12 semanas e 24 semanas (todos os braços)
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Number of Intrusive Memories of Traumatic Event(s)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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?
Prazo: 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
Prazo: 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)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes to Health and Work - Dichotomous Outcomes
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Emily Holmes, Uppsala University (UU), Sweden
- Investigador principal: Amy Beckenstrom, P1vital Products, Wallingford
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P1V-GAINS-IN02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Dados de pesquisa anonimizados serão disponibilizados no OSF indefinidamente.
OSF é um aplicativo da web de código aberto que é livremente acessível ao público e à comunidade científica.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
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