BereavementNCT04588415
Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic
A study testing Bereavement Virtual Support Group in people with Bereavement and Severe Grief Reaction, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This is a feasibility study taking place at The Ottawa Hospital (TOH), Hôpital Montfort, and Queensway Carleton Hospital that seeks to evaluate the impact of the COVID-19 pandemic on family member bereavement and study the effect of virtual support groups on reducing risk of developing Severe Grief Reaction (SGR). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bereavement, Severe Grief Reaction
- What is being tested?
- Bereavement Virtual Support Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jan 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family Members of deceased patients from The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort
Who cannot join
- Anyone who is unable to participate in a virtual intervention
Trial locations and contacts
1 site in 1 country.
About this study
This is a feasibility study taking place at The Ottawa Hospital (TOH), Hôpital Montfort, and Queensway Carleton Hospital that seeks to evaluate the impact of the COVID-19 pandemic on family member bereavement and study the effect of virtual support groups on reducing risk of developing Severe Grief Reaction (SGR). This project is inviting family members of deceased patients at either of the three before mentioned sites to enroll in this study.
Read the detailed description
Background:
Severe grief reactions (SGR), or complicated grief (CG), are experienced by 2-3% of the population after the loss of a loved one, and can be associated with declining health, social distress, increased use of healthcare resources and higher mortality. SGR can be related to the circumstances of the patient at the end of life, particularly in deaths that were unexpected or traumatic, when the family member was unprepared or unsupported. The COVID-19 pandemic has affected many aspects of end-of-life care. For example, infection control measures may reduce interactions between long-term care residents and family members, and have often limited in-person family visiting to the final hours of life, or no visiting at all for patients with COVID-19. Anecdotally, this disruption of normal interactions has been difficult for patients and families alike, and it is known that isolation and lack of closure with a loved one can contribute to the risk of SGR. The prevalence of SGR is expected to rise amid increased challenges in supporting a surge of people with SGR due to physical distancing and limited bereavement resources.
Methods:
The proposed mixed methods explanatory study includes both retrospective and prospective data collection. The quantitative components will principally consist of natural experiments to identify patient/FM characteristics indicating a high risk of SGR during the COVID-19 pandemic. The qualitative components will deepen an understanding of the impact of COVID-19 on bereavement, while providing a formative evaluation for the virtual support groups. Study subjects will include all patients who died in an acute care facility in Ottawa (The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort) from January 1, 2020 until June 30, 2020, and their primary contact (as indicated in their medical record).
Significance:
Early identification of FMs at risk of SGR provides an opportunity for early intervention with the hope of preventing or reducing the severity of the SGR, but it also enables prioritization of those in greatest need, should demand exceed resources. Moreover, because it is still early in the pandemic, the study will be able to collect clinical data about the circumstances of the death, and consistently collect bereavement data for family members of people who died before and after the pandemic struck, and before and after the availability of virtual support groups. Therefore have a unique opportunity to conduct two natural experiments- studying the impact of the COVID pandemic on bereavement, and studying the effect of virtual support groups on symptoms.
- Conditions
- Bereavement, Severe Grief Reaction
- Being tested
- Bereavement Virtual Support Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bereavement Virtual Support GroupOther
Family members who experience loss will be invited to attend a virtual support group (VSG) led by Bereaved Families of Ontario- Ottawa (BFO). In pre-COVID-19 times, BFO presented monthly "Support and Share" nights with guest speakers, followed by breakout peer support groups for all different types of losses: loss of child, spouse, parent, loss by suicide, etc. These groups are facilitated by trained volunteers with a shared loss and include between 75 and 150 participants. These Support and Share Nights serve as intake sessions- interested participants from the breakout groups can attend "Closed Groups" where a smaller group of participants (up to 12) explore their grief more deeply. These run over 8-10 consecutive weeks with the same group of participants. They are led by trained facilitators who have experienced similar losses. Each week has a different theme, based on evidence-based components of bereavement support (e.g. writing a letter to the deceased).
| Study group | Role | What they receive |
|---|---|---|
| Virtual Support Group Arm | Experimental | Those with severe symptoms (indicated by an ICG-r score >25) will be notified that their symptoms are considered to be severe, with a suggestion to attend the virtual support groups. A recent meta-analysis of psychological interventions for grief found higher effect sizes in studies of participants who were >6 months post-loss, and those with higher baseline symptom levels. However, no participant in our study will be randomized to any treatment assignment, and the decision to attend the VSG will be left to the family members. Receives: Other: Bereavement Virtual Support Group |
| Non-Virtual Support Group Arm | No intervention | Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death
This tool, used to detect pathological grief, has a total of 19 questions. Respondents rate the frequency with which they experience each item on a 5-point scale (0-4), ranging from "never" to "always." Respondents with ICG-r scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG-r scores less than or equal to 25. Higher scores result in higher likelihood of CG.
Measured: at 6 months post-death
The Inventory for Complicated Grief-revised (ICG-r) Score at 12 Months Post-death
Participating FMs will have a repeat ICG-r assessment (as described for primary outcome #1) at 12 months post-death.
Measured: at 12 months post-death
Change in ICG-r Score From 6 Months to 12 Months Post-death
The relative changes in ICG-r scores (change in mean score with SD) between 6 and 12 months of family members who participate in the VSGs vs. those who do not will be compared as a measure of the efficacy of the VSG intervention
Measured: at 12 months post-death relative to 6 months post-death
Qualitative Interviews Post-Virtual Support Group
The data for this primary outcome could not be collected due to no participants completing the virtual support group intervention. As a result, no interviews could be conducted. Interviews with family member participants upon completion of the virtual support group intervention were to be conducted to determine usefulness for family members' bereavement process. This is a qualitative method of data collection so there is no scale or score.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start3 Jan 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BereavementStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants in the prospective bereavement data collection component of this study will be invited to participate in the virtual support group (VSG) intervention, regardless of the severity of their symptoms. Those with severe symptoms (indicated by an ICG-r score \>25) will be notified that their symptoms are considered to be severe, with a suggestion to attend the VSGs. A recent meta-analysis of psychological interventions for grief found higher effect sizes in studies of participants who were \>6 months post-loss, and those with higher baseline symptom levels. However, no participant in the study will be randomized to any treatment assignment, and the decision to attend the VSG will be left to the participants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lawlor, Ottawa Hospital Research Institute
- Investigators
- James Downar, MD, Study chair, Ottawa Hospital Research InstitutePeter G Lawlor, MD, Principal investigator, Bruyere Continuing CareHenrique Parsons, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588415
- Sponsor's protocol ID
- 20200653-01H
- Status last verified
- Mar 2025
- First submitted
- 8 Oct 2020
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified prior to entering analysis with anyone outside of the research team
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04588415
- Acronym / sponsor ID
- 20200653-01H
- Conditions
- Bereavement, Severe Grief Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 20 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study taking place at The Ottawa Hospital (TOH), Hôpital Montfort, and Queensway Carleton Hospital that seeks to evaluate the impact of the COVID-19 pandemic on family member bereavement and study the effect of virtual support groups on reducing risk of developing Severe Grief Reaction (SGR). This project is inviting family members of deceased patients at either of the three before mentioned sites to enroll in this study.
Detailed description
Background:
Severe grief reactions (SGR), or complicated grief (CG), are experienced by 2-3% of the population after the loss of a loved one, and can be associated with declining health, social distress, increased use of healthcare resources and higher mortality. SGR can be related to the circumstances of the patient at the end of life, particularly in deaths that were unexpected or traumatic, when the family member was unprepared or unsupported. The COVID-19 pandemic has affected many aspects of end-of-life care. For example, infection control measures may reduce interactions between long-term care residents and family members, and have often limited in-person family visiting to the final hours of life, or no visiting at all for patients with COVID-19. Anecdotally, this disruption of normal interactions has been difficult for patients and families alike, and it is known that isolation and lack of closure with a loved one can contribute to the risk of SGR. The prevalence of SGR is expected to rise amid increased challenges in supporting a surge of people with SGR due to physical distancing and limited bereavement resources.
Methods:
The proposed mixed methods explanatory study includes both retrospective and prospective data collection. The quantitative components will principally consist of natural experiments to identify patient/FM characteristics indicating a high risk of SGR during the COVID-19 pandemic. The qualitative components will deepen an understanding of the impact of COVID-19 on bereavement, while providing a formative evaluation for the virtual support groups. Study subjects will include all patients who died in an acute care facility in Ottawa (The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort) from January 1, 2020 until June 30, 2020, and their primary contact (as indicated in their medical record).
Significance:
Early identification of FMs at risk of SGR provides an opportunity for early intervention with the hope of preventing or reducing the severity of the SGR, but it also enables prioritization of those in greatest need, should demand exceed resources. Moreover, because it is still early in the pandemic, the study will be able to collect clinical data about the circumstances of the death, and consistently collect bereavement data for family members of people who died before and after the pandemic struck, and before and after the availability of virtual support groups. Therefore have a unique opportunity to conduct two natural experiments- studying the impact of the COVID pandemic on bereavement, and studying the effect of virtual support groups on symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants in the prospective bereavement data collection component of this study will be invited to participate in the virtual support group (VSG) intervention, regardless of the severity of their symptoms. Those with severe symptoms (indicated by an ICG-r score >25) will be notified that their symptoms are considered to be severe, with a suggestion to attend the VSGs. A recent meta-analysis of psychological interventions for grief found higher effect sizes in studies of participants who were >6 months post-loss, and those with higher baseline symptom levels. However, no participant in the study will be randomized to any treatment assignment, and the decision to attend the VSG will be left to the participants.
| Arm | Type | Receives |
|---|---|---|
| Virtual Support Group Arm | Experimental | Other: Bereavement Virtual Support GroupThose with severe symptoms (indicated by an ICG-r score >25) will be notified that their symptoms are considered to be severe, with a suggestion to attend the virtual support groups. A recent meta-analysis of psychological interventions for grief found higher effect sizes in studies of participants who were >6 months post-loss, and those with higher baseline symptom levels. However, no participant in our study will be randomized to any treatment assignment, and the decision to attend the VSG will be left to the family members. |
| Non-Virtual Support Group Arm | No intervention | –Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Family Members of deceased patients from The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort
Key exclusion criteria (1 listed)
- Anyone who is unable to participate in a virtual intervention
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 |
|---|---|---|
| Bereavement Virtual Support GroupFamily members who experience loss will be invited to attend a virtual support group (VSG) led by Bereaved Families of Ontario- Ottawa (BFO). In pre-COVID-19 times, BFO presented monthly "Support and Share" nights with guest speakers, followed by breakout peer support groups for all different types of losses: loss of child, spouse, parent, loss by suicide, etc. These groups are facilitated by trained volunteers with a shared loss and include between 75 and 150 participants. These Support and Share Nights serve as intake sessions- interested participants from the breakout groups can attend "Closed Groups" where a smaller group of participants (up to 12) explore their grief more deeply. These run over 8-10 consecutive weeks with the same group of participants. They are led by trained facilitators who have experienced similar losses. Each week has a different theme, based on evidence-based components of bereavement support (e.g. writing a letter to the deceased). | Other | Virtual Support Group Arm |
Primary outcome
The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death
Time frame: at 6 months post-death
This tool, used to detect pathological grief, has a total of 19 questions. Respondents rate the frequency with which they experience each item on a 5-point scale (0-4), ranging from "never" to "always." Respondents with ICG-r scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG-r scores less than or equal to 25. Higher scores result in higher likelihood of CG.
The Inventory for Complicated Grief-revised (ICG-r) Score at 12 Months Post-death
Time frame: at 12 months post-death
Participating FMs will have a repeat ICG-r assessment (as described for primary outcome #1) at 12 months post-death.
Change in ICG-r Score From 6 Months to 12 Months Post-death
Time frame: at 12 months post-death relative to 6 months post-death
The relative changes in ICG-r scores (change in mean score with SD) between 6 and 12 months of family members who participate in the VSGs vs. those who do not will be compared as a measure of the efficacy of the VSG intervention
Qualitative Interviews Post-Virtual Support Group
Time frame: Through study completion, an average of 1 year
The data for this primary outcome could not be collected due to no participants completing the virtual support group intervention. As a result, no interviews could be conducted. Interviews with family member participants upon completion of the virtual support group intervention were to be conducted to determine usefulness for family members' bereavement process. This is a qualitative method of data collection so there is no scale or score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. All data will be de-identified prior to entering analysis with anyone outside of the research team
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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.
James Downar, MD study chair
Ottawa Hospital Research Institute
Peter G Lawlor, MD principal investigator
Bruyere Continuing Care
Henrique Parsons, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bereavement Virtual Support Group in people with Bereavement and Severe Grief Reaction, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death (time frame: at 6 months post-death). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2025.