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

NCT07607808 | Not Yet Recruiting

• 2 other identifiers: 25-252EK 26-029
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; Smartphone-based alert system; Mobile App Alert System

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks after the event

Secondary Outcomes (2)

• Change in post-traumatic stress symptom severity measured by PCL-5 total score

  From 4 weeks to 10 weeks after the event

• Difference in post-traumatic stress symptom severity between debriefing and control groups

  4 weeks and 10 weeks after the event

Study Arms (2)

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.

Behavioral: Structured Debriefing

Interventions

Structured Debriefing BEHAVIORAL

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.

Intervention (Structured debriefing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Aachen: lead
• Alexianer Center for Mental Health Care, Aachen: collaborator
• Aachen Institute for Rescue Management and Public Safety (ARS), RWTH Aachen University: collaborator

Study Sites (1)

Aachen Institute for Rescue Management and Public Safety (ARS), RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52068, Germany

Location

Related Links

• Official website of the CAREMORE project.

MeSH Terms

Conditions

Psychological Well-Being; Stress Disorders, Post-Traumatic; Heart Arrest; Stress, Psychological; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms

Central Study Contacts

Mark Pitsch, MD

CONTACT

0049 241 432 37 6300; mpitsch@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators are not blinded due to the nature of the intervention. However, interview data are analyzed independently by assessors who are blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Department of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)