Trial Outcomes & Findings for Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic (NCT NCT04588415)
NCT ID: NCT04588415
Last Updated: 2025-03-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
at 6 months post-death
Results posted on
2025-03-20
Participant Flow
Participant milestones
| Measure |
Virtual Support Group Arm
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. No participant will be randomized to any treatment assignment. The decision to attend the VSG is left to the family members.
Bereavement Virtual Support Group: 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- participants from the breakout groups can attend "Closed Groups" where a smaller group of participants (up to 12) explore 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).
|
Non-Virtual Support Group Arm
Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
121
|
|
Overall Study
COMPLETED
|
0
|
121
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic
Baseline characteristics by cohort
| Measure |
Virtual Support Group Arm
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. No participant will be randomized to any treatment assignment. The decision to attend the VSG is left to the family members.
Bereavement Virtual Support Group: 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- participants from the breakout groups can attend "Closed Groups" where a smaller group of participants (up to 12) explore 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).
|
Non-Virtual Support Group Arm
n=121 Participants
Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
58.4 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
80 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
41 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
—
|
92 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
—
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African, Caribbean, or non-specified Black
|
—
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latin, Central, and South American
|
—
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indigenous (First Nations, Métis, non-status)
|
—
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed (Jamaican and French, German and Jamaican)
|
—
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
—
|
121 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Physical presence of family in the last 48 h of life
Yes
|
—
|
95 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Physical presence of family in the last 48 h of life
No
|
—
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Virtual presence of family in the last 48 h of life
Yes
|
—
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Virtual presence of family in the last 48 h of life
No
|
—
|
103 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Physical/in person interaction between the team and family in the last 5 days of life
|
—
|
3 Number of interactions
STANDARD_DEVIATION 3.3 • n=7 Participants
|
3 Number of interactions
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Brief Family Relationship Scale (Total score)
|
—
|
14.0 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
14.0 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Relationship to deceased
Spouse/partner
|
—
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Relationship to deceased
Child
|
—
|
75 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Relationship to deceased
Sibling
|
—
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Relationship to deceased
Friend
|
—
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Relationship to deceased
Other
|
—
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Phone call interaction between the team and family in the last 5 days of life
|
—
|
2.3 Number of interactions
STANDARD_DEVIATION 2.4 • n=7 Participants
|
2.3 Number of interactions
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Virtual interaction between the team and family in the last 5 days of life
|
—
|
0.2 Number of interactions
STANDARD_DEVIATION 0.7 • n=7 Participants
|
0.2 Number of interactions
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
ICU admission
Yes
|
—
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
ICU admission
No
|
—
|
82 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Intubation
Yes
|
—
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Intubation
No
|
—
|
96 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Decedent age
|
—
|
80.1 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
80.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Decedent sex
Male
|
—
|
67 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Decedent sex
Female
|
—
|
54 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Death disposition
Medicine
|
—
|
88 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Death disposition
ICU
|
—
|
33 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Days in hospital
|
—
|
12.0 days
STANDARD_DEVIATION 18.0 • n=7 Participants
|
12.0 days
STANDARD_DEVIATION 18.0 • n=5 Participants
|
|
Participant education
Did not complete high school
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Participant education
High school (some or all)
|
—
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Participant education
Post-secondary education
|
—
|
94 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Participant marital status
Single
|
—
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Participant marital status
Common-law
|
—
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Participant marital status
Married
|
—
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Participant marital status
Separated
|
—
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Participant marital status
Divorced
|
—
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Participant marital status
Widowed
|
—
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 6 months post-deathPopulation: No participants indicated they attended a virtual support group.
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.
Outcome measures
| Measure |
Virtual Support Group Arm
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. No participant will be randomized to any treatment assignment. The decision to attend the VSG is left to the family members.
Bereavement Virtual Support Group: 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- participants from the breakout groups can attend "Closed Groups" where a smaller group of participants (up to 12) explore 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).
|
Non-Virtual Support Group Arm
n=121 Participants
Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm
|
|---|---|---|
|
The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death
ICG total score >25
|
—
|
35 Participants
|
|
The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death
ICG total score ≤ 25
|
—
|
86 Participants
|
PRIMARY outcome
Timeframe: at 12 months post-deathPopulation: No participants indicated they attended a virtual support group. Of the 121 participants who completed the baseline grief assessment, 111 completed the follow-up assessment 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.
Outcome measures
| Measure |
Virtual Support Group Arm
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. No participant will be randomized to any treatment assignment. The decision to attend the VSG is left to the family members.
Bereavement Virtual Support Group: 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- participants from the breakout groups can attend "Closed Groups" where a smaller group of participants (up to 12) explore 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).
|
Non-Virtual Support Group Arm
n=111 Participants
Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm
|
|---|---|---|
|
The Inventory for Complicated Grief-revised (ICG-r) Score at 12 Months Post-death
ICG >25 at follow-up
|
—
|
32 Participants
|
|
The Inventory for Complicated Grief-revised (ICG-r) Score at 12 Months Post-death
ICG ≤25 at follow-up
|
—
|
79 Participants
|
PRIMARY outcome
Timeframe: at 12 months post-death relative to 6 months post-deathPopulation: No participants indicated they attended a virtual support group. Of the 121 participants who completed the baseline grief assessment, 111 completed the follow-up assessment at 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
Outcome measures
| Measure |
Virtual Support Group Arm
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. No participant will be randomized to any treatment assignment. The decision to attend the VSG is left to the family members.
Bereavement Virtual Support Group: 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- participants from the breakout groups can attend "Closed Groups" where a smaller group of participants (up to 12) explore 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).
|
Non-Virtual Support Group Arm
n=111 Participants
Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm
|
|---|---|---|
|
Change in ICG-r Score From 6 Months to 12 Months Post-death
|
—
|
-0.01 score on a scale
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearThe 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.
Outcome measures
Outcome data not reported
Adverse Events
Virtual Support Group Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Virtual Support Group Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place