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

2026年5月21日 更新者: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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

75

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • North Rhine-Westphalia
      • Aachen、North Rhine-Westphalia、ドイツ、52068
        • Aachen Institute for Rescue Management and Public Safety (ARS), RWTH Aachen University Hospital
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Post-traumatic stress symptom severity measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) total score
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in post-traumatic stress symptom severity measured by PCL-5 total score
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月1日

一次修了 (推定)

2027年5月1日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2026年5月8日

QC基準を満たした最初の提出物

2026年5月21日

最初の投稿 (実際)

2026年5月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月26日

QC基準を満たした最後の更新が送信されました

2026年5月21日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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