- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07631741
Moral Injury Study Among Healthcare Professionals in Psychiatric Facilities in the PACA Region (MI-PSY)
A Mixed Epidemiological Study of Moral Injury Among Healthcare Professionals in Psychiatric Facilities in the PACA Region
Healthcare professionals working in psychiatric settings face demanding working conditions characterized by high rates of burnout and specific constraints, such as the deprivation of patients' liberty. *Moral Injury* (MI), a relatively recent concept, extends beyond burnout by focusing on the distress arising from ethical conflicts and the dissonance between professional values and the realities of clinical practice. Although the concept has begun to emerge from a theoretical perspective, particularly in the United States, it remains largely unknown in France and has yet to be investigated in psychiatric settings at the international level.
We hypothesize that MI plays a central role in healthcare professionals' psychological distress and contributes to the major recruitment and retention crisis affecting public psychiatric institutions. This crisis is reflected, for example, in a 40% vacancy rate for hospital physician positions in public facilities, with particularly acute shortages in child and adolescent psychiatry. The demographic crisis in child and adolescent psychiatry is unprecedented, marked by a 30% decline in the workforce over the past decade and projections suggesting a further 50% reduction within the next ten years. At the same time, mental health disorders among adolescents-particularly suicide attempts among girls-have increased substantially since the COVID-19 pandemic.
This study aims to explore the organizational, individual, and systemic factors associated with Moral Injury in order to better understand and prevent this form of professional suffering.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study is a regional cross-sectional observational survey conducted electronically through online questionnaires administered via the LimeSurvey platform of Aix-Marseille University, which is certified for Health Data Hosting (HDS). The coordinating center will distribute the survey to institutions affiliated with the Psynovia Psychiatry Federation.
Participation in the study is voluntary, and data collection is pseudonymized. Participants may withdraw from the study at any time without consequence. Completion of the questionnaires is expected to take approximately 20 minutes.
No intervention involving the study population is planned as part of this research. Upon completion of the survey, participants who feel the need to discuss their psychological well-being (e.g., stress, anxiety, sleep disturbances, depressive symptoms, or burnout) will be encouraged to seek support from a healthcare professional, such as their occupational health service and/or primary care physician.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Sophie LAFOND
- Telefonnummer: +33 483772062
- E-Mail: sophie.lafond@ch-toulon.fr
Studieren Sie die Kontaktsicherung
- Name: Nadège BOURVIS, MD
- E-Mail: nadege.bourvis@ch-toulon.fr
Studienorte
-
-
-
Toulon, Frankreich
- Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer
-
Kontakt:
- Sophie LAFOND
- Telefonnummer: +33 483772062
- E-Mail: sophie.lafond@ch-toulon.fr
-
Hauptermittler:
- Nadège BOURVIS, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Healthcare Professionals working on Psychiatric Facilities in the PACA Region
Exclusion Criteria:
- Absence of consent
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Healthcare workers in psychiatry
All healthcare Professionals working in Psychiatric Facilities in the PACA Region territories
|
Health workers will be invited to complete an online self-questionnaire
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Moral Injury Inventory for Healthcare Professionals
Zeitfenster: One point : Baseline
|
An overall score out of 100 will be created for the inventory, where a high score indicates a high level of "Moral Injury"
|
One point : Baseline
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Moral Injury Events Scale
Zeitfenster: One point : Baseline
|
Minimum score = 11, Maximum score = 66 Higher average scores indicate greater intensity of experience
|
One point : Baseline
|
|
Maslach Burnout Inventory
Zeitfenster: One point : Baseline
|
3 scores calculated in this inventory Burnout : minimum score = 0, maximum score = 63, Higher average scores indicate greater intensity of burnout Depersonalization : minimum score = 0, maximum score = 35, Higher average scores indicate greater intensity of depersonalization Personal fulfillment : minimum score = 0, maximum score = 56, Higher average scores indicate greater intensity of personal fulfillment
|
One point : Baseline
|
|
Copenhagen Psychosocial Questionnaire
Zeitfenster: One point : Baseline
|
Assesses psychosocial working conditions across domains such as job demands, work organization, social relations, leadership, and well-being.
Scores are typically scaled from 0 to 100, with higher scores indicating either more favorable conditions (e.g., social support, job satisfaction) or greater psychosocial risk (e.g., stress, emotional demands), depending on the domain assessed.
|
One point : Baseline
|
|
Team Psychological Safety on 7 points
Zeitfenster: One point : Baseline
|
Scale measures the extent to which team members feel safe to speak up, ask questions, admit mistakes, and express concerns without fear of negative consequences.
Items are rated on a 7-point Likert scale, with higher scores indicating greater perceived psychological safety within the team.
|
One point : Baseline
|
|
Turnover Intention Scale-6
Zeitfenster: One point : Baseline
|
Scale assesses an employee's intention to leave their current job or organization.
Items are rated on a Likert scale, with higher scores indicating a stronger intention to quit and a greater risk of staff turnover.
|
One point : Baseline
|
|
Patient Health Questionnaire-4
Zeitfenster: One point : Baseline
|
This is a brief screening tool combining two items for anxiety and two for depression, used to assess overall psychological distress.
Higher total scores indicate greater levels of anxiety and depressive symptoms, with established cut-offs used to categorize severity from minimal to severe distress.
|
One point : Baseline
|
|
World Health Organization Well-Being Index - 5
Zeitfenster: One point : Baseline
|
Assesses short self-reported measure of current psychological well-being, assessing positive mood, vitality, and general interest in life over the past two weeks.
Scores range from 0 to 25 (or 0 to 100 when transformed), with higher scores indicating better well-being and lower scores suggesting reduced well-being or possible depression.
|
One point : Baseline
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienleiter: Nadège BOURVIS, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
- Studienstuhl: Laurent BOYER, MD, Aix Marseille Université
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Dean W, Morris D, Llorca PM, Talbot SG, Fond G, Duclos A, Boyer L. Moral Injury and the Global Health Workforce Crisis - Insights from an International Partnership. N Engl J Med. 2024 Sep 5;391(9):782-785. doi: 10.1056/NEJMp2402833. Epub 2024 Aug 31. No abstract available.
- Papazian L, Hraiech S, Loundou A, Herridge MS, Boyer L. High-level burnout in physicians and nurses working in adult ICUs: a systematic review and meta-analysis. Intensive Care Med. 2023 Apr;49(4):387-400. doi: 10.1007/s00134-023-07025-8. Epub 2023 Mar 27.
- Boyer L, Wu AW, Fernandes S, Tran B, Brousse Y, Nguyen TT, Yon DK, Auquier P, Lucas G, Boussat B, Fond G. Exploring the fear of clinical errors: associations with socio-demographic, professional, burnout, and mental health factors in healthcare workers - A nationwide cross-sectional study. Front Public Health. 2024 Jun 26;12:1423905. doi: 10.3389/fpubh.2024.1423905. eCollection 2024.
- Fond G, Smith L, Tran B, Lucas G, Nguyen TT, Yon DK, Boyer L. Unmasking the triad of burnout, absenteeism, and poor sleep among healthcare workers during the third wave of COVID-19 pandemics. Results from the national AMADEUS study. J Affect Disord. 2024 Jun 15;355:247-253. doi: 10.1016/j.jad.2024.03.157. Epub 2024 Mar 28.
- Fond G, Smith L, Boussat B, Lucas G, Yon DK, Tran B, Nguyen TT, Stubbs B, Boyer L. Association between physical activity and health in healthcare professionals : Results from the nationwide AMADEUS survey. Rev Epidemiol Sante Publique. 2023 Dec;71(6):102183. doi: 10.1016/j.respe.2023.102183. Epub 2023 Nov 7.
- Coelho J, Lucas G, Micoulaud-Franchi JA, Tran B, Yon DK, Taillard J, D'Incau E, Philip P, Boyer L, Fond G. Sleep timing, workplace well-being and mental health in healthcare workers. Sleep Med. 2023 Nov;111:123-132. doi: 10.1016/j.sleep.2023.09.013. Epub 2023 Sep 21.
- Fond G, Lucas G, Boyer L. Health-promoting work schedules among nurses and nurse assistants in France: results from nationwide AMADEUS survey. BMC Nurs. 2023 Aug 3;22(1):255. doi: 10.1186/s12912-023-01403-9.
- Coelho J, Taillard J, Bernard A, Lopez R, Fond G, Boyer L, Lucas G, Alla F, Buysse DJ, Wallace ML, Verdun-Esquer C, Geoffroy PA, d'Incau E, Philip P, Micoulaud-Franchi JA. Emotional Exhaustion, a Proxy for Burnout, Is Associated with Sleep Health in French Healthcare Workers without Anxiety or Depressive Symptoms: A Cross-Sectional Study. J Clin Med. 2023 Feb 27;12(5):1895. doi: 10.3390/jcm12051895.
- Fond G, Fernandes S, Lucas G, Greenberg N, Boyer L. Depression in healthcare workers: Results from the nationwide AMADEUS survey. Int J Nurs Stud. 2022 Nov;135:104328. doi: 10.1016/j.ijnurstu.2022.104328. Epub 2022 Jul 23.
- Lucas G, Colson S, Boyer L, Gentile S, Fond G. Work environment and mental health in nurse assistants, nurses and health executives: Results from the AMADEUS study. J Nurs Manag. 2022 Oct;30(7):2268-2277. doi: 10.1111/jonm.13599. Epub 2022 Apr 19.
- Lucas G, Colson S, Boyer L, Gentile S, Fond G. [Influence of the work environment on burn-out and depression in nurses]. Rev Infirm. 2022 Jan;71(277):34-35. doi: 10.1016/j.revinf.2021.11.011. Epub 2021 Dec 2. French.
- Lucas G, Colson S, Boyer L, Inthavong K, Haller PH, Lancon C, Auquier P, Gentile S, Fond G. Risk factors for burnout and depression in healthcare workers: The national AMADEUS study protocol. Encephale. 2022 Jun;48(3):247-253. doi: 10.1016/j.encep.2021.06.001. Epub 2021 Oct 16.
- Fond G, Bourbon A, Lancon C, Boucekine M, Micoulaud-Franchi JA, Auquier P, Boyer L. Psychiatric and psychological follow-up of undergraduate and postgraduate medical students: Prevalence and associated factors. Results from the national BOURBON study. Psychiatry Res. 2019 Feb;272:425-430. doi: 10.1016/j.psychres.2018.12.174. Epub 2018 Dec 31.
- Kansoun Z, Boyer L, Hodgkinson M, Villes V, Lancon C, Fond G. Burnout in French physicians: A systematic review and meta-analysis. J Affect Disord. 2019 Mar 1;246:132-147. doi: 10.1016/j.jad.2018.12.056. Epub 2018 Dec 18.
- Fond G, Bourbon A, Micoulaud-Franchi JA, Auquier P, Boyer L, Lancon C. Psychiatry: A discipline at specific risk of mental health issues and addictive behavior? Results from the national BOURBON study. J Affect Disord. 2018 Oct 1;238:534-538. doi: 10.1016/j.jad.2018.05.074. Epub 2018 Jun 15.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025-CHITS-012
- 2026-A00514-47 (Andere Kennung: Id-RCB)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Moralische Verletzung
-
National Yang Ming Chiao Tung University HospitalAbgeschlossen
-
NYU Langone HealthAbgeschlossenPatientenbindung | MoralVereinigte Staaten
-
University of Cape TownBill and Melinda Gates FoundationAbgeschlossen
-
Baqiyatallah Medical Sciences UniversityNoch keine RekrutierungMoral | Behandlungscompliance
-
Hamad Medical CorporationRekrutierungMoral | VA-ECMOKatar
-
West China HospitalAbgeschlossenKörperzusammensetzung | Krebsüberlebender | Moral
-
National Defense Medical Center, TaiwanAbgeschlossenHerz-Kreislauf-Erkrankungen | Moral | IntensivpflegeTaiwan
-
University of California, San FranciscoBill and Melinda Gates Foundation; Ministry of Health, NigerBeendetGesundheit des Kindes | Moral | Implementierung | Resistenz BakteriellVereinigte Staaten
-
Ottawa Hospital Research InstituteAbgeschlossenMoral | Polypharmazie | Epidemiologie | Chirurgischer Eingriff, operativ
-
ABDULZAHRA HUSSAINKing's College Hospital NHS Trust; Spire, Inc.; Heart of England NHS Trust; The... und andere MitarbeiterAbgeschlossenMoral | Revisionen nach MGB/OAGB | Morbiditäten
Klinische Studien zur Self-Questionnaires for Healthcare Workers
-
Ajou University School of MedicineKorea Health Industry Development Institute; Sungshin Women's UniversityRekrutierungJugendsuizid und Selbstverletzung Intervention: Klinische und biologische Ergebnisse Studie (SHIELD)Suizidgedanken | Selbstmord, versucht | Selbstverletzendes VerhaltenSüdkorea
-
Pakistan Institute of Living and LearningNoch keine RekrutierungSelbstmord | SelbstbeschädigungPakistan
-
Jaeb Center for Health ResearchAktiv, nicht rekrutierendMukoviszidoseVereinigte Staaten