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

Psychological Disorder Clinical Trial

— COVIDAAD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05566366
• Other study ID #: APHP210638
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Carla DE STEFANO, Dr
• Phone: +33148 96 44 61
• Email: carla.destefano[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Mental Disorders
• Psychological Disorder

Intervention

Other:
• Qualitative research interview
Qualitative research interview Administration of quantitative scales

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	• 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
Secondary	• 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
Secondary	• 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
Secondary	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
Secondary	• 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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