NCT06302764

Brief Summary

The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows:

  1. 1.Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms.
  2. 2.Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams.
  3. 3.Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols.
  4. 4.Assessment of the potential for implementing the results in solutions utilizing virtual reality technology.
  5. 5.Formation of an interdisciplinary international research team.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

March 4, 2024

Last Update Submit

April 12, 2024

Conditions

Keywords

stresswork-related stresstraumaPTSDmedical personnel

Outcome Measures

Primary Outcomes (4)

  • Focused Interview

    Interviews pertaining to physical injury risk, psychosocial factors, and personal indicators

    October, 2023 until November, 2023

  • Posttraumatic Stress Disorder Checklist (PCL-5)

    Posttraumatic Stress Disorder Checklist - 20-item, self-report measure to assess the symptoms of posttraumatic stress disorder. Items are rated on 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely). A general score ranges from 0 to 80 with a higher score indicating a higher symptoms of posttraumatic stress disorder.

    December, 2023 until March, 2024

  • Patient Health Questionnaire (PHQ-9)

    Patient Health Questionnaire - 9-item, self-report measure to assess the severity of depression. Items are rated on 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A general score ranges from 0 to 27 with a higher score indicating a higher depressive symptom severity.

    December, 2023 until March, 2024

  • Depersonalization Mechanism Scale (DMS)

    Depersonalization Mechanism Scale - a 20-item, self-report measure to assess the tendency to depersonalization. Items are rated on 5-point Likert scale, ranging from 0 (never) to 4 (very often). A general score ranges from 0 to 80 with a higher score indicating a higher tendency to depersonalization.

    December, 2023 until March, 2024

Study Arms (4)

Polish Medical Staff

Medical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions

Diagnostic Test: Qualitative & Quantitative Research

Ukrainian Medical Staff

Medical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions

Diagnostic Test: Qualitative & Quantitative Research

Portuguese Medical Staff

Medical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions

Diagnostic Test: Qualitative & Quantitative Research

Spanish Medical Staff

Medical doctors, and emergency staff (paramedics), involved in treating life-threatening conditions

Diagnostic Test: Qualitative & Quantitative Research

Interventions

1. Focused interviews - conducted by members of the appointed research team to recognize the issues faced by emergency medical staff in Poland, Ukraine, Portugal, and Spain with the aim of preparing the measurement framework. 2. Online questionnaire surveys - conducted using the Qualtrics platform (available in different, language versions - Polish, Ukrainian, Portuguese, and Spanish).

Polish Medical StaffPortuguese Medical StaffSpanish Medical StaffUkrainian Medical Staff

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical staff involved in treating life-threatening conditions

You may qualify if:

  • completed medical studies or emergency medical course
  • assistance in life-threatening conditions

You may not qualify if:

  • Intellectual disability
  • Inability to self-complete the research questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute of Applied Psychology, Jagiellonian University in Krakow, Poland

Krakow, Małopolska, 30-348, Poland

RECRUITING

University of Coimbra

Coimbra, Portugal

RECRUITING

Bogomolets National Medical University

Kyiv, Ukraine

RECRUITING

MeSH Terms

Conditions

Occupational StressStress Disorders, Post-TraumaticStress, PsychologicalWounds and Injuries

Condition Hierarchy (Ancestors)

Occupational DiseasesBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Krystyna Golonka, Prof

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Krystyna Golonka, Prof

CONTACT

Katarzyna Sitnik-Warchulska, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

October 1, 2023

Primary Completion

April 20, 2024

Study Completion

June 30, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations