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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01642-37 | Registry Identifier | ID-RCB | |
| 1-20-046 ID 48680 | Other Identifier | CPP SOOM-1 |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Health care workers working in hospital or nursing home for elderly people involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion, unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making.
Preliminary data suggests that frontline and lay professionals suffer from different types of psychological distress. These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as Eye Movement Desensitization and Reprocessing (EMDR, desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19.
This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).
Health care workers working in hospital or nursing home for elderly people involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion, unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making. Preliminary data from China suggests that frontline and lay professionals suffer from different types of psychological distress. A study of the mental health of 230 frontline medical staff in the COVID-19 outbreak found a high prevalence of anxiety and stress disorder (up to 25%).
These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as EMDR (desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19. EMDR is a therapy which for nearly 30 years has demonstrated, through well-conducted international experimental studies with a high level of evidence including a recent meta-analysis from 2019, its effectiveness in the treatment of post-traumatic stress disorder and depression. Its use is recommended by the French National Authority for Health and the World Health Organization. In France, more than 1,700 therapists practice it. While the evidence for the effectiveness of EMDR is strong and its feasibility adapted to a crisis such as the COVID-19 pandemic, its use has not been evaluated at the population level in the context of an exceptional health crisis.
This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).
In addition, this project is also built to allow health professionals involved in the fight against COVID-19 to have regular access to self-administered screening with immediate feedback concerning the most frequent psychological symptoms, this method of screening and monitoring psychological distress in the context of a pandemic is not currently implemented in France.
The objectives of the study are as follows:
/ Create a cohort of French hospital health-care workers and French health professionals working in nursing home for elderly people involved in the care of COVID-19 patients in which we will:
/ To evaluate, in a randomized controlled trial, the effectiveness of 12 sessions of a specific therapeutic intervention combining "EMDR + usual care" compared to "usual care" alone in eligible participants (those screened positive for psychological symptoms) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Subject from this group are screened positive for psychological distress but they will only receive standard of care. | |
| Eye Movement Desensitization & Reprocessing Group | Experimental | Subject from this group are screened positive for psychological distress. They will receive 12 sessions of Eye Movement Desensitization & Reprocessing therapy by a trained therapist over three months in addition to standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMDR | Behavioral | The EMDR therapy is organized in eight different phases, requiring attending multiple sessions, usually 12 separate sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on symptoms of Post-Traumatic Stress Disorder | This study is investigating three different conditions (PTSD, Depression and Burnout) each assessed with its own primary endpoint. Thus, the trial will have three primary endpoints. Change over a 6 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are. | From inclusion to 6 months after inclusion |
| Efficacy on symptoms of Burnout | Change over a 6 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are. | From inclusion to 6 months after inclusion |
| Efficacy on symptoms of Depression | Change over a 6 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are. | From inclusion to 6 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term efficacy on symptoms of PTSD | Change over a 3 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are. | From inclusion to 3 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on suicidal ideation | Changes in the level of suicidal ideation over a 6 months period from baseline measured by Visual Analog Scale (VAS). The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is. | From inclusion to 6 months after inclusion |
| Long-term efficacy on suicidal ideation |
Inclusion Criteria in the cohort:
Inclusion criteria in the EMDR trial:
Exclusion Criteria in the cohort:
Exclusion criteria in the EMDR trial:
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| Name | Affiliation | Role |
|---|---|---|
| Wissam EL-HAGE, MD-PhD | University Hospital of TOURS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Investigation Clinique 1415 | Tours | Centre-Val de Loire | 37044 | France | ||
| Bretonneau Regional Universitary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37052108 | Derived | Caille A, Allemang-Trivalle A, Blanchin M, Rebion A, Sauvaget A, Gohier B, Birmes P, Bui E, Fakra E, Krebs MO, Lemogne C, Prieto N, Jalenques I, Vidailhet P, Aouizerate B, Hingray C, El-Hage W. EMDR for symptoms of depression, stress and burnout in health care workers exposed to COVID-19 (HARD): A study protocol for a trial within a cohort study. Eur J Psychotraumatol. 2023;14(1):2179569. doi: 10.1080/20008066.2023.2179569. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D002055 | Burnout, Professional |
| D013313 | Stress Disorders, Post-Traumatic |
| D000086382 | COVID-19 |
| D000077062 | Burnout, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000073397 | Occupational Stress |
| D009784 | Occupational Diseases |
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| ID | Term |
|---|---|
| D057169 | Eye Movement Desensitization Reprocessing |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Trials Within Cohort (TWIC) :
Participants are included within a cohort. They are screened using an online self-administered questionnaire for psychological distress (Post-Traumatic Stress Disorder, Burnout, Depression) every three months for one year.
People who are positive after screening (at M0 or M3 or M6) will be eligible for the trial and some of them will be randomly assigned to the treatment group. The rest of the cohort will be the second arm (control group).
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| Short-term efficacy on symptoms of Burnout | Change over a 3 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are. | From inclusion to 3 months after inclusion |
| Short-term efficacy on symptoms of Depression | Change over a 3 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are. | From inclusion to 3 months after inclusion |
| Long-term efficacy on symptoms of PTSD | Change over a 12 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5) for the participants who will be enrolled in the trial at M0 of the cohort. The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are. | From inclusion to 12 months after inclusion |
| Long-term efficacy on symptoms of Burnout | Change over a 12 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL) for the participants who will be enrolled in the trial at M0 of the cohort. The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are. | From inclusion to 12 months after inclusion |
| Long-term efficacy on symptoms of Depression | Change over a 12 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9) for the participants who will be enrolled in the trial at M0 of the cohort. The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are. | From inclusion to 12 months after inclusion |
| Efficacy on symptoms of Anxiety | Change over a 6 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7). The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are. | From inclusion to 6 months after inclusion |
| Long-term efficacy on symptoms of Anxiety | Change over a 12 months period in anxiety measured by the Generalized Anxiety Disorder-7 questionnaire (GAD-7) for the participants who will be enrolled in the trial at M0 of the cohort. The GAD-7 score is on a scale from 0 to 21. The higher the score, the higher the level of anxiety symptoms are. | From inclusion to 12 months after inclusion |
| Efficacy on suicide attempts | Number of suicide attempts over a 6-month period from baseline | From inclusion to 6 months after inclusion |
Changes in the level of suicidal ideation over a 12 months period from baseline measured by Visual Analog Scale (VAS) for the participants who are enrolled in the trial at M0 of the cohort. The VAS is on a scale from 0 to 10. The higher the VAS score, the higher suicidal ideation level is. |
| From inclusion to 12 months after inclusion |
| Efficacy on the impact of health on functioning: Role Emotional | Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is. | From inclusion to 6 months after inclusion |
| Long-term efficacy on the impact of health on functioning: Role Emotional | Change in the impact of health on functioning (Role Emotional (RE) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RE score is on a scale from 0 to 100. The higher the score, the better Role Emotional is. | From inclusion to 12 months after inclusion |
| Efficacy on the impact of health on functioning: Role Physical | Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 6 months period from baseline. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is. | From inclusion to 6 months after inclusion |
| Long-term efficacy on the impact of health on functioning: Role Physical | Change in the impact of health on functioning (Role Physical (RP) subdomain of the MOS Short Form-36 health survey v1.3 (SF-36)) over a 12 months period from baseline for the participants who are enrolled in the trial at M0 of the cohort. The RP score is on a scale from 0 to 100. The higher the score, the better Role Physical is. | From inclusion to 12 months after inclusion |
| Substance use | Evolution of substance use over 6 months | From inclusion to 6 months after inclusion |
| Long-term substance use | Evolution of substance use over 12 months for the participants who are enrolled in the trial at M0 of the cohort | From inclusion to 12 months after inclusion |
| Medication use | Evolution of medication use over 6 months | From inclusion to 6 months after inclusion |
| Long-term medication use | Evolution of medication use over 12 months for the participants who are enrolled in the trial at M0 of the cohort | From inclusion to 12 months after inclusion |
| Health care utilization | Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient. | From inclusion to 6 months after inclusion |
| Long-term health care utilization | Number of consultations of health professionals within the period of follow-up (general practitioner, psychiatrist, psychotherapist, psychologist, professionals who are practicing alternative medicines); Occurrence of EMDR therapy within the control group; Number of visits at the emergency unit of a hospital; Number of nights spent in hospital as a patient (short-term); Number of nights spent in rehabilitation facilities as a patient. For the participants who are enrolled in the trial at M0 of the cohort | From inclusion to 12 months after inclusion |
| Acceptability of EMDR in the EMDR group | Proportion of those who will be offered EMDR and will actually receive EMDR | From inclusion to 12 months after inclusion |
| Compliance in the EMDR group | Number of sessions attended over the total planned number | From inclusion to 12 months after inclusion |
| Tours |
| 37044 cedex 9 |
| France |
| D013315 |
| Stress, Psychological |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |