Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic

NCT04588415 | Completed Results DMC

• 1 other identifier: 20200653-01H
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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). This project is inviting family members of deceased patients at either of the three before mentioned sites to enroll in this study.

Conditions

Bereavement; Severe Grief Reaction

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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.

  Through study completion, an average of 1 year

Study Arms (2)

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.

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

Interventions

Bereavement Virtual Support Group OTHER

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).

Virtual Support Group Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Family Members of deceased patients from The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort

You may not qualify if:

• Anyone who is unable to participate in a virtual intervention

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Results Point of Contact

• Title: Dr. James Downar
• Organization: University of Ottawa

jdownar@toh.ca

613 562 6262

Study Officials

• James Downar, MD

  Ottawa Hospital Research Institute

  STUDY CHAIR

• Peter G Lawlor, MD

  Bruyere Continuing Care

  PRINCIPAL INVESTIGATOR

• Henrique Parsons, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 19, 2020
• Study Start: January 3, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)