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Psychological Stress and Support Needs of Volunteer First Responders After Smartphone-based Cardiac Arrest Alerts (BRAVE)

21 de maio de 2026 atualizado por: Mark Pitsch, University Hospital, Aachen

Burden and Resilience After Volunteer Engagement in Out-of-Hospital Cardiac Arrest

Out-of-hospital cardiac arrest is a serious emergency. In many areas, trained volunteers are alerted by a smartphone app to help before emergency services arrive. While this can save lives, these situations can also be emotionally stressful for the volunteers. This study looks at how these experiences affect volunteer first responders and how they cope with them. It also examines whether a structured follow-up conversation after an event can help reduce stress.

People who respond to a cardiac arrest alert can take part in the study. Participants will answer short questionnaires about their well-being about four weeks and ten weeks after the event. Some participants will also be offered a guided conversation to talk about their experience, while others will not.

The researchers will compare both groups to see if the conversation helps reduce stress over time. The study will also explore which factors may increase or reduce emotional burden.

Participants can stop answering the questionnaires at any time. If signs of increased stress are identified, support options are available. With consent, the study team may contact participants to offer further information and help connect them with support services.

The results of this study may help improve support for volunteer first responders in the future.

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Descrição detalhada

Out-of-hospital cardiac arrest (OHCA) remains a major cause of mortality worldwide. Early initiation of cardiopulmonary resuscitation by bystanders is a key determinant of survival. To improve response times, many regions have implemented smartphone-based alerting systems that notify nearby volunteer first responders of suspected cardiac arrest events.

While these systems have demonstrated clinical benefits, the psychological impact on volunteer responders is not yet fully understood. Responding to OHCA incidents may involve exposure to emotionally challenging situations, including unsuccessful resuscitation attempts or distressing scene conditions. At the same time, engagement in such life-saving efforts may also be associated with positive psychological effects, such as a sense of meaning or competence. A better understanding of both burden and resilience factors is needed to optimize support strategies for this population.

The BRAVE study (Burden and Resilience After Volunteer Engagement) is designed to investigate the psychological impact of smartphone-based OHCA alerts on volunteer first responders and to evaluate whether a structured post-event debriefing intervention can improve psychological outcomes.

Participants are recruited via the Corhelper smartphone application, which is routinely used to alert volunteer responders. After completing a routine post-event questionnaire, responders may indicate their interest in being contacted about study participation. Only individuals who provide explicit consent will be contacted by the study team and receive detailed study information.

The study follows a randomized controlled design. Participants are prospectively assigned to either an intervention group receiving a structured debriefing conversation or a control group without this intervention. The allocation ratio is approximately 1:2 due to resource constraints related to the delivery of the intervention.

The structured debriefing consists of a guided conversation conducted by a physician member of the study team, with the option to involve trained personnel from the psychosocial support (PSU) team. The conversation focuses on the reconstruction of the event, clarification of medical and situational aspects, and the individual processing of the experience. The intervention aims to support participants in understanding and coping with the event.

Psychological outcomes are assessed using standardized questionnaires at approximately four weeks (T1) and ten weeks (T2) after the event. Symptoms of post-traumatic stress are measured using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). Personality traits are additionally assessed using the Big Five Inventory (BFI).

Exploratory analyses will additionally assess potential correlations between post-traumatic stress symptoms and individual or event-related factors. These may include prior medical background, previous resuscitation experience, pre-existing personal stress, personality traits measured by the BFI, time to arrival at the scene, resuscitation outcome, and the number of first responders present.

To ensure participant safety, a structured support pathway is implemented. Signs of increased psychological distress are identified based on questionnaire results and/or clinical impression during personal interactions. If indicated, participants may receive additional support, including further conversations with the study team, involvement of the PSU team, or referral to specialized mental health services in cooperation with the Alexianer Center for Mental Health. In the case of questionnaire-based assessments, participants may be contacted proactively by the study team if they have previously consented to such contact.

The study aims to generate evidence on the psychological effects of first responder systems and to evaluate the potential benefit of structured debriefing interventions. The results are expected to inform the development of targeted support strategies for volunteer first responders and contribute to the sustainable implementation of smartphone-based alerting systems.

Tipo de estudo

Intervencional

Inscrição (Estimado)

75

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Alemanha, 52068
        • Aachen Institute for Rescue Management and Public Safety (ARS), RWTH Aachen University Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Volunteer first responders alerted through the "Corhelper" smartphone application
  • Sufficient German language skills to understand the study information and to participate in the debriefing conversation and questionnaires
  • Written informed consent for study participation
  • Actual arrival at the scene with direct exposure to the resuscitation situation (e.g., visual contact with the patient or active participation in resuscitation measures)

Exclusion Criteria:

  • Age below 18 years
  • Anticipated severe post-traumatic stress symptoms during the course of the study, in order to avoid possible retraumatization
  • Already enrolled in the study following a different Corhelper alert event

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Control (No debriefing)
Participants in this group do not receive the structured debriefing intervention. They complete the scheduled follow-up questionnaires at predefined time points without additional structured support.
Experimental: Intervention (Structured debriefing)
Participants in this group receive a structured debriefing conversation conducted by a team including physician members of the study team and trained psychosocial support (PSU) personnel. The conversation focuses on reviewing the event, clarifying medical and situational aspects, and supporting the individual processing of the experience.
The intervention consists of a structured debriefing conversation conducted by a team including physician members of the study team and trained psychosocial support (PSU) personnel. The conversation follows a semi-structured format and includes a guided reconstruction of the event, clarification of medical and situational aspects, and support in the individual processing of the experience. The aim is to facilitate understanding, reduce uncertainty, and support coping with the event.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Post-traumatic stress symptom severity measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) total score
Prazo: 4 weeks after the event
Post-traumatic stress symptoms are assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). Total scores range from 0 to 80, with higher scores indicating greater symptom severity.
4 weeks after the event

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in post-traumatic stress symptom severity measured by PCL-5 total score
Prazo: From 4 weeks to 10 weeks after the event
Post-traumatic stress symptoms are assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). Total scores range from 0 to 80, with higher scores indicating greater symptom severity. Change is calculated as the difference between the 10-week and 4-week scores.
From 4 weeks to 10 weeks after the event
Difference in post-traumatic stress symptom severity between debriefing and control groups
Prazo: 4 weeks and 10 weeks after the event
PCL-5 total scores and changes in PCL-5 total scores are compared between participants assigned to the structured debriefing group and participants assigned to the control group.
4 weeks and 10 weeks after the event

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de maio de 2026

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

1 de novembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared due to the sensitive nature of the psychological and personal data collected in this study and the risk of participant re-identification despite pseudonymization.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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