- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
The hypothesis is 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophie LAFOND
- Phone Number: +33 483772062
- Email: sophie.lafond@ch-toulon.fr
Study Contact Backup
- Name: Nadège BOURVIS, MD
- Email: nadege.bourvis@ch-toulon.fr
Study Locations
-
-
-
Toulon, France
- Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer
-
Contact:
- Sophie LAFOND
- Phone Number: +33 483772062
- Email: sophie.lafond@ch-toulon.fr
-
Principal Investigator:
- Nadège BOURVIS, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthcare Professionals working on Psychiatric Facilities in the PACA Region
Exclusion Criteria:
- Absence of consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moral Injury Inventory for Healthcare Professionals
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moral Injury Events Scale
Time Frame: One point : Baseline
|
Minimum score = 11, Maximum score = 66 Higher average scores indicate greater intensity of experience
|
One point : Baseline
|
|
Maslach Burnout Inventory
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Nadège BOURVIS, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
- Study Chair: Laurent BOYER, MD, Aix Marseille Université
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-CHITS-012
- 2026-A00514-47 (Other Identifier: Id-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Moral Injury
-
IRCCS San RaffaeleUniversità Vita-Salute San RaffaeleCompletedHealthy Controls | Moral Development | Moral Dilemma | Moral JustificationItaly
-
VA Office of Research and DevelopmentMinneapolis Veterans Affairs Medical Center; Michael E. DeBakey VA Medical... and other collaboratorsEnrolling by invitationMoral Injury SyndromeUnited States
-
National Human Genome Research Institute (NHGRI)CompletedGenetic Counseling | Moral Value Conflicts | Moral DistressUnited States
-
Central Arkansas Veterans Healthcare SystemVA Pittsburgh Healthcare SystemRecruiting
-
Academisch Medisch Centrum - Universiteit van Amsterdam...UnknownEthical Dilemmas | Ethical Issues | Moral Issues | Moral Dilemmas | Anaesthesiology | AnaesthesiologistNetherlands
-
Mayo ClinicMayo Clinic Center for Clinical and Translational Science (CCaTS)Enrolling by invitationWellbeing | Wellness | Moral Injury | Nurse Well-being | Nurse Health | Nurses | Moral Distress | Wellness, Psychological | Post-Traumatic StressUnited States
-
Bilecik Seyh Edebali UniversitesiCompleted
-
VA Office of Research and DevelopmentActive, not recruitingMoral Injury | Functional ImpairmentUnited States
-
VA Office of Research and DevelopmentCompletedMoral InjuryUnited States
-
Nevsehir Haci Bektas Veli UniversityCompletedEthics | Moral DistressTurkey
Clinical Trials on Self-Questionnaires for Healthcare Workers
-
Centre Hospitalier Intercommunal de Toulon La Seyne...Recruiting
-
Universidad Internacional de ValenciaUniversity of Guadalajara; University of Valencia; University of Buenos Aires; Universidad... and other collaboratorsRecruitingDepression | Quality of Life | Stress | Burnout, Professional | Anxiety | Sleep Disturbance | Fatigue, CompassionMexico
-
University of NottinghamCompletedPsychological WellbeingUnited Kingdom
-
Kutahya Health Sciences UniversityCompleted
-
CanSagligi FoundationCompletedBurnout, ProfessionalTurkey
-
Centre Hospitalier Universitaire de NiceNot yet recruiting
-
Fresenius KabiTerminatedTumors and Home Parenteral NutritionGermany
-
Robert SimpsonNot yet recruitingBurnout | CompassionCanada
-
Robert SimpsonRecruiting
-
Ahvaz Jundishapur University of Medical SciencesCompletedPromoting Skin Cancer Protective BehaviorsIran, Islamic Republic of