NCT05566366

Brief 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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

June 27, 2022

Last Update Submit

November 15, 2023

Conditions

Keywords

COVID19 related psychological disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • Description of the socio-demographic characteristics of the bereaved

    9 months

  • Exploration of the relational aspects between the bereaved, his deceased and the rest of his family circle.

    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

    9 months

  • Analysis of the relational dimensions between the bereaved and the healthcare team

    9 months

  • Exploration of support practices for the deceased (s) and funeral rites practices implemented by the bereaved

    9 months

  • +10 more secondary outcomes

Study Arms (1)

population who lost a loved one during the COVID19 health crisis

OTHER

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

Interventions

Qualitative research interview Administration of quantitative scales

population who lost a loved one during the COVID19 health crisis

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 32799105BACKGROUND
  • 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.

    PMID: 24068457BACKGROUND
  • 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.

    PMID: 32298748BACKGROUND
  • 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.

    PMID: 21216470BACKGROUND
  • 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.

    PMID: 33414728BACKGROUND
  • 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.

    PMID: 32112714BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Carla DE STEFANO, Dr

    Avicenne Hospital-APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla DE STEFANO, Dr

CONTACT

Zahia BEN ABDESSELAM, PM

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

October 4, 2022

Study Start

March 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11