Understanding the Impact of Death Conditions Linked to the COVID-19 Crisis on the Grieving Process in Bereaved Families (COVIDAAD)

Understanding the Impact of Death Conditions Linked to the COVID-19 Health Crisis on the Grieving Process in Bereaved Families (Adolescents and Adults): a Qualitative Study

This study aims to analyze the grieving process of people who have lost a close first degree relative, understand the impact of death conditions and model a "theory of mourning" in the context of the COVID-19 crisis .

Study Overview

• Status: Not yet recruiting
• Conditions: Psychological Disorder
• Intervention / Treatment: Other: Qualitative research interview

Detailed Description

The COVID-19 pandemic has confronted us with an unprecedented health crisis, this had major consequences on mental health . International literature has already shown an increase in psychological and psychiatric distress in patients followed in psychiatry, and in the general population.

For bereaved relatives, certain factors contribute to complicate the mourning process, such as: the absence of communication with the healthcare team, the prohibition of visits, the absence of funeral rites... In the proposed research, we will analyze the grieving process of people who have lost a close first degree relative in children and adolescents population, understand the repercussions conditions of death in bereaved families and model a "theory of mourning" in the context of the current epidemic health crisis.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla DE STEFANO, Dr; Phone Number: +33148 96 44 61; Email: carla.destefano@aphp.fr
• Study Contact Backup: Name: Zahia BEN ABDESSELAM, PM; Phone Number: +331 48 95 74 35; Email: zahia.ben-abdesselam@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Bereaved person who lost a close relative (child, adolescent, adult) since March 2020
• Age over 15 years old
• First degree relative (husband-wife or equivalent, father-mother, son-daughter, brother-sister)
• A bereaved person who is in at least one of the following conditions:
• Unable to visit the hospital if hospitalized OR
• Unable to travel to the home/EPHAD/hospital OR
• Wish not to travel for personal reasons OR
• Failure to perform funeral rites OR
• Failure to respect the wishes of the deceased and his or her own wishes OR
• Inability to see the deceased OR
• Opportunity to participate in the funeral OR
• Unable to say goodbye OR
• Inability to communicate via telephone and/or smartphone OR
• Unable to repatriate the body to the country or region of origin
• Relative who died (child, adolescent, adult) between March 2020 and March 2021 with Covid-19 or other life-threatening conditions
• Relative who died in an inpatient or outpatient setting (EPHAD, home or other structure)
• French or non-French speaking bereaved person

Exclusion Criteria:

• Presence of a pathology preventing good elocution during the interview:

  • Presence of a neurological pathology (e.g. dementia, Alzheimer's, aphasia, dysphasia)
  • Presence of an unstabilised psychiatric disorder
• Person under guardianship or curatorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: population who lost a loved one during the COVID19 health crisis; Analyze the grieving process of people who have lost a close first degree relative, understand the impact of death conditions on this process and model a "theory of mourning" in the context of the actual epidemic health crisis.	Other: Qualitative research interview; Qualitative research interview Administration of quantitative scales

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify the most traumatic aspects for bereaved families and better identify risk factors that may complicate the grieving process and contribute to the development of possible psychopathology.	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the socio-demographic characteristics of the bereaved	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Exploration of the relational aspects between the bereaved, his deceased and the rest of his family circle.	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Exploration of the history of the disease (Covid-19 and not Covid-19) and care management (extra-hospital and / or intra-hospital) until the announcement of the death	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Analysis of the relational dimensions between the bereaved and the healthcare team	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Exploration of support practices for the deceased (s) and funeral rites practices implemented by the bereaved	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Analysis of coping strategies and resilience factors of the bereaved person	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
• Exploration of the dimensions of the lived experience and feelings of the grieving person • Exploration of the psychological state of the bereaved	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
• Exploration of the bereaved person's experience of reporting the epidemic in the media and the COVID-19 disease (whether or not they have contracted it)	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
• Assessment of pathological grief (Inventory of Complicated Grief - ICG) • Connor-Davidson ResilienceScale (CD-RISC) Resilience Assessment • Assessment of post-traumatic symptoms in adolescent Children'sRevised Impact of Events Scale (CRIES)	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Assessment of post-traumatic symptoms in adults (Post-Traumatic Stress Disorder) (Post-traumatic stress disorder checklist version DSM-5) (PCL-5)	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
• Assessment of pathological grief (Inventory of Complicated Grief - ICG)	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Connor-Davidson ResilienceScale (CD-RISC) Resilience Assessment	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Assessment of post-traumatic symptoms in adolescent Children'sRevised Impact of Events Scale (CRIES)	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Hogan Inventory Bereavement - Short Form - Children and Adolescent Mourning Scale (HIB-SF-CA)	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months
Adolescent Resilience Assessment Child and YouthResilienceMeasure (CYRM-R)	In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided	9 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Carla DE STEFANO, Dr, Avicenne Hospital-APHP

Publications and helpful links

General Publications

• Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.
• Xiong J, Lipsitz O, Nasri F, Lui LMW, Gill H, Phan L, Chen-Li D, Iacobucci M, Ho R, Majeed A, McIntyre RS. Impact of COVID-19 pandemic on mental health in the general population: A systematic review. J Affect Disord. 2020 Dec 1;277:55-64. doi: 10.1016/j.jad.2020.08.001. Epub 2020 Aug 8.
• Shear MK, Ghesquiere A, Glickman K. Bereavement and complicated grief. Curr Psychiatry Rep. 2013 Nov;15(11):406. doi: 10.1007/s11920-013-0406-z.
• Wallace CL, Wladkowski SP, Gibson A, White P. Grief During the COVID-19 Pandemic: Considerations for Palliative Care Providers. J Pain Symptom Manage. 2020 Jul;60(1):e70-e76. doi: 10.1016/j.jpainsymman.2020.04.012. Epub 2020 Apr 13.
• Kersting A, Brahler E, Glaesmer H, Wagner B. Prevalence of complicated grief in a representative population-based sample. J Affect Disord. 2011 Jun;131(1-3):339-43. doi: 10.1016/j.jad.2010.11.032. Epub 2011 Jan 8.
• Demartini B, Nistico V, D'Agostino A, Priori A, Gambini O. Early Psychiatric Impact of COVID-19 Pandemic on the General Population and Healthcare Workers in Italy: A Preliminary Study. Front Psychiatry. 2020 Dec 22;11:561345. doi: 10.3389/fpsyt.2020.561345. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: COVID19 related psychological disorders
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Mental Disorders
• Other Study ID Numbers: APHP210638

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No