Psychological DisorderCOVIDAADNCT05566366
Understanding the Impact of Death Conditions Linked to the COVID-19 Crisis on the Grieving Process in Bereaved Families
A study testing Qualitative research interview in people with Psychological Disorder, run by Assistance Publique - Hôpitaux de Paris.
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 . Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Disorder
- What is being tested?
- Qualitative research interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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 .
Read the 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.
- Conditions
- Psychological Disorder
- Being tested
- Qualitative research interview
- Keywords
- COVID19 related psychological disorders
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative research interviewOther
Qualitative research interview Administration of quantitative scales
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Qualitative research interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Psychological DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla DE STEFANO, Dr, Principal investigator, Avicenne Hospital-APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566366
- Sponsor's protocol ID
- APHP210638
- Acronym
- COVIDAAD
- Status last verified
- Nov 2023
- First submitted
- 27 Jun 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32799105Shear MK, Ghesquiere A, Glickman K. Bereavement and complicated grief. Curr Psychiatry Rep. 2013 Nov;15(11):406. doi: 10.1007/s11920-013-0406-z.
PubMed 24068457Wallace 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.
PubMed 32298748Kersting 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.
PubMed 21216470Demartini 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.
PubMed 33414728Brooks 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.
PubMed 32112714
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05566366
- Acronym / sponsor ID
- COVIDAAD / APHP210638
- Conditions
- Psychological Disorder
- Keywords
- COVID19 related psychological disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| population who lost a loved one during the COVID19 health crisis | Other | Other: Qualitative research interviewAnalyze 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of a pathology preventing good elocution during the interview:
- Person under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative research interviewQualitative research interview Administration of quantitative scales | Other | population who lost a loved one during the COVID19 health crisis |
Primary outcome
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.
Time frame: 9 months
In accordance with good practice in qualitative methodology, no secondary judging criteria should be used be provided
15 secondary outcomes
Description of the socio-demographic characteristics of the bereaved
Time frame: 9 months
Exploration of the relational aspects between the bereaved, his deceased and the rest of his family circle.
Time frame: 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
Time frame: 9 months
Analysis of the relational dimensions between the bereaved and the healthcare team
Time frame: 9 months
Exploration of support practices for the deceased (s) and funeral rites practices implemented by the bereaved
Time frame: 9 months
Analysis of coping strategies and resilience factors of the bereaved person
Time frame: 9 months
• Exploration of the dimensions of the lived experience and feelings of the grieving person • Exploration of the psychological state of the bereaved
Time frame: 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)
Time frame: 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)
Time frame: 9 months
Assessment of post-traumatic symptoms in adults (Post-Traumatic Stress Disorder) (Post-traumatic stress disorder checklist version DSM-5) (PCL-5)
Time frame: 9 months
• Assessment of pathological grief (Inventory of Complicated Grief - ICG)
Time frame: 9 months
Connor-Davidson ResilienceScale (CD-RISC) Resilience Assessment
Time frame: 9 months
Assessment of post-traumatic symptoms in adolescent Children'sRevised Impact of Events Scale (CRIES)
Time frame: 9 months
Hogan Inventory Bereavement - Short Form - Children and Adolescent Mourning Scale (HIB-SF-CA)
Time frame: 9 months
Adolescent Resilience Assessment Child and YouthResilienceMeasure (CYRM-R)
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 32799105Xiong 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.
- Background: PubMed 24068457Shear MK, Ghesquiere A, Glickman K. Bereavement and complicated grief. Curr Psychiatry Rep. 2013 Nov;15(11):406. doi: 10.1007/s11920-013-0406-z.
- Background: PubMed 32298748Wallace 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.
- Background: PubMed 21216470Kersting 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.
- Background: PubMed 33414728Demartini 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.
- Background: PubMed 32112714Brooks 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.
Related trials for Psychological Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla DE STEFANO, Dr principal investigator
Avicenne Hospital-APHP
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative research interview in people with Psychological Disorder, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla DE STEFANO, Dr (+33148 96 44 61, carla.destefano@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566366, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.