Mental HealthBRAVENCT07607808
Psychological Stress and Support Needs of Volunteer First Responders After Smartphone-based Cardiac Arrest Alerts
A study testing Structured Debriefing in people with Mental Health and Stress Disorder, Post Traumatic, run by University Hospital, Aachen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Stress Disorder, Post Traumatic
- What is being tested?
- Structured Debriefing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Aachen Institute for Rescue Management and Public Safety (ARS), RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52068
Mark Pitsch, MD, 0049 241 432 37 6300, mpitsch@ukaachen.de
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Mental Health, Stress Disorder, Post Traumatic
- Being tested
- Structured Debriefing
- Keywords
- First Responders, Cardiac Arrest, Psychological Stress, Mental Health, Debriefing, Volunteer Responders, Out-of-Hospital Cardiac Arrest, Resilience, Smartphone-based alert system, Mobile App Alert System
- Medical subject headings
- Psychological Well-Being, Stress Disorders, Post-Traumatic, Heart Arrest, Stress, Psychological, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured DebriefingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control (No debriefing) | No intervention | 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. |
| Intervention (Structured debriefing) | Experimental | 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. Receives: Behavioral: Structured Debriefing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic stress symptom severity measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) total score
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.
Measured: 4 weeks after the event
Secondary outcomes (2)
Change in post-traumatic stress symptom severity measured by PCL-5 total score
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.
Measured: From 4 weeks to 10 weeks after the event
Difference in post-traumatic stress symptom severity between debriefing and control groups
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.
Measured: 4 weeks and 10 weeks after the event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned in a 1:2 ratio to either a structured debriefing intervention group or a control group without intervention. Both groups are followed in parallel, with psychological outcomes assessed at predefined time points.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aachen
- Sponsor type
- University, hospital or other
- Collaborators
- Alexianer Center for Mental Health Care, Aachen, Aachen Institute for Rescue Management and Public Safety (ARS), RWTH Aachen University
- Responsible party
- Principal investigator, Mark Pitsch, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607808
- Sponsor's protocol ID
- 25-252
- Other IDs
- EK 26-029
- Acronym
- BRAVE
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden and Resilience After Volunteer Engagement in Out-of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT07607808
- Acronym / sponsor ID
- BRAVE / 25-252
- Conditions
- Mental Health, Stress Disorder, Post Traumatic
- Keywords
- First Responders, Cardiac Arrest, Psychological Stress, Mental Health, Debriefing, Volunteer Responders, Out-of-Hospital Cardiac Arrest, Resilience
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, AachenUniversity, hospital or other
- Collaborators
- Alexianer Center for Mental Health Care, Aachen, Aachen Institute for Rescue Management and Public Safety (ARS), RWTH Aachen University
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:2 ratio to either a structured debriefing intervention group or a control group without intervention. Both groups are followed in parallel, with psychological outcomes assessed at predefined time points.
| Arm | Type | Receives |
|---|---|---|
| Control (No debriefing) | No intervention | –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. |
| Intervention (Structured debriefing) | Experimental | Behavioral: Structured DebriefingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured DebriefingThe 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. | Behavioural | Intervention (Structured debriefing) |
Primary outcome
Post-traumatic stress symptom severity measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) total score
Time frame: 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.
2 secondary outcomes
Change in post-traumatic stress symptom severity measured by PCL-5 total score
Time frame: From 4 weeks to 10 weeks after the event
Difference in post-traumatic stress symptom severity between debriefing and control groups
Time frame: 4 weeks and 10 weeks after the event
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Official website of the CAREMORE project.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Debriefing in people with Mental Health and Stress Disorder, Post Traumatic, run by University Hospital, Aachen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Pitsch, MD (0049 241 432 37 6300, mpitsch@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic stress symptom severity measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) total score (time frame: 4 weeks after the event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.