Severe Grief ReactionNCT03985592
ICU BEREAVE: Feasibility of a Multi-component Bereavement Support Intervention to Prevent Severe Grief Reaction
A study testing Education in people with Severe Grief Reaction, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Nearly 1% of the Canadian population dies every year. When people die, their bereaved family members (FMs) normally experience grief that diminishes over time and without serious psychological or medical impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Grief Reaction
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 2 Feb 2020to 7 Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A family member of a recently deceased patient at the Ottawa Hospital ICU
Who cannot join
- Non-Family Member
- Death not in ICU
Trial locations and contacts
1 site in 1 country.
About this study
Nearly 1% of the Canadian population dies every year. When people die, their bereaved family members (FMs) normally experience grief that diminishes over time and without serious psychological or medical impairment. However, some FMs experience a severe grief reaction (SGR) with intense symptoms and impairment lasting months or years; this is more common among FMs of those who die in the Intensive Care Unit (ICU). Many bereaved FMs would like to have bereavement support, and many ICU organizations identify bereavement support as a clinical and research priority, yet few ICUs provide routine support.
In order to determine the feasibility and acceptability of a complex support intervention for bereaved FMs, the investigators will pilot a multi-component bereavement intervention through a mixed-methods study. Methods will include a series of semi-structured interviews, questionnaires and narrative therapy sessions. The target population for this study is both ICU clinical staff (e.g. physicians, registered nurses [RN], allied health professionals) and FMs of relatives who died in the ICU. The intervention is premised on a robust series of educational modules aimed at increasing ICU staff members' knowledge of and level of comfort with bereavement support ICU FMs.
In a previous study, the investigators have established that SGRs can be predicted using screening tools early after the loss, and that ICU-based clinicians are eager to provide bereavement support. There are effective treatments for SGRs once they have been diagnosed after 6 months, but this can mean many months of suffering for the FM. In this project, the investigators plan to develop and test the feasibility of an early bereavement support program that follows bereaved FMs after a loss, provides information and support, and uses effective therapies aimed at preventing the development of a SGR.
Read the detailed description
Almost 1% of the population dies annually. When people die, it is normal for their bereaved family members (FMs) to experience grief. This grief usually diminishes, but in some cases FMs suffer from severe grief reaction (SGR) with intense yearning or separation distress, as well as emotional, cognitive and functional impairment lasting months or years. SGRs are linked with declining health, increased use of healthcare resources, and even death. ICU deaths are associated with a higher incidence of SGR2 - symptoms of psychiatric illness and have been reported in 34-67% of surviving FMs with 22% experiencing significant social distress.
As grieving death is an expected human response, SGRs cannot be diagnosed until >6 months after a loss, but the investigators found that a SGR at 6 months can be accurately predicted by screening tests 3 months after a death. Early identification provides opportunity for early intervention with the hope of preventing or reducing the severity of SGRs. There are effective treatments for established SGRs (i.e. >6 months post-death), including psychotherapy tailored to SGR. This therapy works through 3 mechanisms: (1) by encouraging exposure to reminders and situations that the FM is avoiding, (2) restructuring through reconstructing an understanding of the loss and grief experience, and (3) behavioural activation to re-establish social interaction. Some ICU-based support interventions administered pre-death are effective in reducing psychological morbidity, while others have shown no effect or even harm.
Many bereaved FMs would appreciate bereavement support, and ICU organizations have identified bereavement support as a clinical and research priority. Yet few ICUs have devoted resources toward bereavement screening or support. Our previous multi-centre study found that only 16% of Canadian ICU clinicians follow up with FMs after a death, and bereaved FMs rarely, if ever, report being contacted after the death of their loved one. Few ICU clinicians have received formal training in bereavement support and many report "not knowing what to say" in response to strong emotions.
Currently, less than half of Canadian ICU clinicians (physicians and registered nurses [RN]) are comfortable providing any form of bereavement support to FMs at the time of death, and fewer than 18% perceive that FMs may have social or informational needs following a death. Similarly, FMs are often unwilling or unable to access bereavement support even when resources are available with over half of eligible participants declining participation in ICU-based bereavement interventions.
Single interventions are not effective for preventing SGRs in unselected populations of bereaved FMs (thought may benefit high-risk populations). Thus our pilot project will combine several promising scalable and low-resource interventions in a "bundle", to improve the chances of meeting these needs and overcoming these barriers. As a research-based intervention, this study will examine the feasibility of implementing measures to reduce SGRs while also determining the best methods to address the social and educational needs of clinicians and FM.
- Conditions
- Severe Grief Reaction
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Also called Bereavement support, social, and SGR risk assessment
Intervention description provided in elaboration on arms of the study.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention for ICU-Based Clinicians | Other | ICU-based clinicians (e.g. physicians, RNs, and social workers) will be provided with educational modules related to bereavement support for family members. Following the modules a survey will be provided to participants to assess their perceived usefulness of the modules. Receives: Behavioral: Education |
| Educational material and personalized card of condolence | Experimental | Members of the ICU team who cared for deceased ICU patients will be asked to send a letter of condolence to family members listed as the patient's primary contact and provide them with educational modules related to bereavement support for family members. Receives: Behavioral: Education |
| Virtual meeting with the care team to address unmet needs | Experimental | At 8-12 weeks post-death, the study team will contact FMs and invite them to meet virtually with the care team. Our observational studies indicated that the most common need reported by bereaved FMs was the desire to meet with the care team to review events during the ICU stay and particularly the events that led to death, and that this was the type of support that ICU clinicians were most comfortable providing. Receives: Behavioral: Education |
| Offering a facilitated storytelling intervention session | Experimental | At six months post-death, the study team will contact FMs and administer the Inventory of Complicated Grief-Revised (ICG-r), Brief Grief Questionnaire (BGQ), Impact of Events Scale - Revised (IES-r), Patient Health Questionnaire-9 (PHQ-9), and the Bereavement Dependency Scale (BDS). FMs who complete all questionnaires will be invited to participate in a 1-2-hour narrative exploration of their grief and bereavement experience, regardless of the severity of their symptoms. Those with severe symptoms will be notified of symptom severity, and offered to participate in the narrative exploration of their grief and bereavement experience. Storytelling interventions require specialized resources but the results of Barnato et al., as well as the response to our qualitative interviews, suggest that this intervention may only be helpful for selected FMs. Storytelling interventions have been shown to reduce healthcare utilization and improve subjective health following a traumatic experience. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Inventory of Complicated Grief-Revised (ICG-r)
Indicates rate of pathological grief. 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 scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG scores less than or equal to 25. Higher scores result in higher likelihood of CG.
Measured: At 6 months post death
Brief Grief Questionnaire (BGQ)
A self reporting instrument assessing complicated grief. A total of 5 questions on a 3 point scale. A total score of 10 is possible. Higher scores result in higher likelihood of CG.
Measured: At 6 months post death
Impact of Events Scale - Revised (IES-r)
A self reporting instrument that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales. Higher scores are linked with a greater likelihood of distress
Measured: At 6 months post death
Patient Health Questionnaire-9 (PHQ-9)
A multipurpose instrument for screening for severity of depression. A total of 9 questions. Respondents answer from "0" to "4" for each question. The total range is from 0 to 36. A higher score is correlated with greater level of depression.
Measured: At 6 months post death
Bereavement Dependency Scale (BDS)
Used as a predictor of enduring and complicated grief. A total of 6 questions. Items are rated on a 5 point scale from "1" to "5". A higher score is linked to dependency on deceased.
Measured: At 6 months post death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start2 Feb 2020
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Why it stopped: The investigators experienced several barriers: including COVID-19 delays on research, high staff turnover, and burnout amongst ICU Nursing Staff. The study team and ICU staff determined low feasibility of completing Phase 2, 3, and 4 as a result.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Grief ReactionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The multi-component intervention aims to evaluate the feasibility as well as success of imparting educational knowledge and applied techniques to ICU clinicians (i.e., physicians, RNs, social workers) on how to support bereaved FMs. The overall purpose of the intervention is to optimize preemptive strategies in reducing SGRs in FMs. To determine the effectiveness of this intervention a series of standardized and validated measures of wellbeing will be given to FMs after the typical bereavement period ends. The intervention is designed to be implementable in any ICU setting across Canada and potentially abroad.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Virtual Hospice
- Responsible party
- Principal investigator, James Downar, Ottawa Hospital Research Institute
- Investigators
- James Downar, MD, Principal investigator, PhysicianBrandi Vanderspank-Wright, Phd,RN, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985592
- Sponsor's protocol ID
- 1466
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2019
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participant data will be kept securely by the research team and de-identified for any future publication.
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
- ICU BEREAVE: Feasibility of a Multi-component Bereavement Support Intervention to Prevent Severe Grief Reaction
- ClinicalTrials.gov ID
- NCT03985592
- Acronym / sponsor ID
- 1466
- Conditions
- Severe Grief Reaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The investigators experienced several barriers: including COVID-19 delays on research, high staff turnover, and burnout amongst ICU Nursing Staff. The study team and ICU staff determined low feasibility of completing Phase 2, 3, and 4 as a result.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Virtual Hospice
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 13 Jun 2019 (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.
Nearly 1% of the Canadian population dies every year. When people die, their bereaved family members (FMs) normally experience grief that diminishes over time and without serious psychological or medical impairment. However, some FMs experience a severe grief reaction (SGR) with intense symptoms and impairment lasting months or years; this is more common among FMs of those who die in the Intensive Care Unit (ICU). Many bereaved FMs would like to have bereavement support, and many ICU organizations identify bereavement support as a clinical and research priority, yet few ICUs provide routine support.
In order to determine the feasibility and acceptability of a complex support intervention for bereaved FMs, the investigators will pilot a multi-component bereavement intervention through a mixed-methods study. Methods will include a series of semi-structured interviews, questionnaires and narrative therapy sessions. The target population for this study is both ICU clinical staff (e.g. physicians, registered nurses [RN], allied health professionals) and FMs of relatives who died in the ICU. The intervention is premised on a robust series of educational modules aimed at increasing ICU staff members' knowledge of and level of comfort with bereavement support ICU FMs.
In a previous study, the investigators have established that SGRs can be predicted using screening tools early after the loss, and that ICU-based clinicians are eager to provide bereavement support. There are effective treatments for SGRs once they have been diagnosed after 6 months, but this can mean many months of suffering for the FM. In this project, the investigators plan to develop and test the feasibility of an early bereavement support program that follows bereaved FMs after a loss, provides information and support, and uses effective therapies aimed at preventing the development of a SGR.
Detailed description
Almost 1% of the population dies annually. When people die, it is normal for their bereaved family members (FMs) to experience grief. This grief usually diminishes, but in some cases FMs suffer from severe grief reaction (SGR) with intense yearning or separation distress, as well as emotional, cognitive and functional impairment lasting months or years. SGRs are linked with declining health, increased use of healthcare resources, and even death. ICU deaths are associated with a higher incidence of SGR2 - symptoms of psychiatric illness and have been reported in 34-67% of surviving FMs with 22% experiencing significant social distress.
As grieving death is an expected human response, SGRs cannot be diagnosed until >6 months after a loss, but the investigators found that a SGR at 6 months can be accurately predicted by screening tests 3 months after a death. Early identification provides opportunity for early intervention with the hope of preventing or reducing the severity of SGRs. There are effective treatments for established SGRs (i.e. >6 months post-death), including psychotherapy tailored to SGR. This therapy works through 3 mechanisms: (1) by encouraging exposure to reminders and situations that the FM is avoiding, (2) restructuring through reconstructing an understanding of the loss and grief experience, and (3) behavioural activation to re-establish social interaction. Some ICU-based support interventions administered pre-death are effective in reducing psychological morbidity, while others have shown no effect or even harm.
Many bereaved FMs would appreciate bereavement support, and ICU organizations have identified bereavement support as a clinical and research priority. Yet few ICUs have devoted resources toward bereavement screening or support. Our previous multi-centre study found that only 16% of Canadian ICU clinicians follow up with FMs after a death, and bereaved FMs rarely, if ever, report being contacted after the death of their loved one. Few ICU clinicians have received formal training in bereavement support and many report "not knowing what to say" in response to strong emotions.
Currently, less than half of Canadian ICU clinicians (physicians and registered nurses [RN]) are comfortable providing any form of bereavement support to FMs at the time of death, and fewer than 18% perceive that FMs may have social or informational needs following a death. Similarly, FMs are often unwilling or unable to access bereavement support even when resources are available with over half of eligible participants declining participation in ICU-based bereavement interventions.
Single interventions are not effective for preventing SGRs in unselected populations of bereaved FMs (thought may benefit high-risk populations). Thus our pilot project will combine several promising scalable and low-resource interventions in a "bundle", to improve the chances of meeting these needs and overcoming these barriers. As a research-based intervention, this study will examine the feasibility of implementing measures to reduce SGRs while also determining the best methods to address the social and educational needs of clinicians and FM.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The multi-component intervention aims to evaluate the feasibility as well as success of imparting educational knowledge and applied techniques to ICU clinicians (i.e., physicians, RNs, social workers) on how to support bereaved FMs. The overall purpose of the intervention is to optimize preemptive strategies in reducing SGRs in FMs. To determine the effectiveness of this intervention a series of standardized and validated measures of wellbeing will be given to FMs after the typical bereavement period ends. The intervention is designed to be implementable in any ICU setting across Canada and potentially abroad.
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention for ICU-Based Clinicians | Other | Behavioral: EducationICU-based clinicians (e.g. physicians, RNs, and social workers) will be provided with educational modules related to bereavement support for family members. Following the modules a survey will be provided to participants to assess their perceived usefulness of the modules. |
| Educational material and personalized card of condolence | Experimental | Behavioral: EducationMembers of the ICU team who cared for deceased ICU patients will be asked to send a letter of condolence to family members listed as the patient's primary contact and provide them with educational modules related to bereavement support for family members. |
| Virtual meeting with the care team to address unmet needs | Experimental | Behavioral: EducationAt 8-12 weeks post-death, the study team will contact FMs and invite them to meet virtually with the care team. Our observational studies indicated that the most common need reported by bereaved FMs was the desire to meet with the care team to review events during the ICU stay and particularly the events that led to death, and that this was the type of support that ICU clinicians were most comfortable providing. |
| Offering a facilitated storytelling intervention session | Experimental | Behavioral: EducationAt six months post-death, the study team will contact FMs and administer the Inventory of Complicated Grief-Revised (ICG-r), Brief Grief Questionnaire (BGQ), Impact of Events Scale - Revised (IES-r), Patient Health Questionnaire-9 (PHQ-9), and the Bereavement Dependency Scale (BDS). FMs who complete all questionnaires will be invited to participate in a 1-2-hour narrative exploration of their grief and bereavement experience, regardless of the severity of their symptoms. Those with severe symptoms will be notified of symptom severity, and offered to participate in the narrative exploration of their grief and bereavement experience. Storytelling interventions require specialized resources but the results of Barnato et al., as well as the response to our qualitative interviews, suggest that this intervention may only be helpful for selected FMs. Storytelling interventions have been shown to reduce healthcare utilization and improve subjective health following a traumatic experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A family member of a recently deceased patient at the Ottawa Hospital ICU
Key exclusion criteria (2 listed)
- Non-Family Member
- Death not in ICU
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 |
|---|---|---|
| EducationAlso: Bereavement support, social, and SGR risk assessmentIntervention description provided in elaboration on arms of the study. | Behavioural | Educational Intervention for ICU-Based Clinicians, Educational material and personalized card of condolence, Offering a facilitated storytelling intervention session, Virtual meeting with the care team to address unmet needs |
Primary outcome
The Inventory of Complicated Grief-Revised (ICG-r)
Time frame: At 6 months post death
Indicates rate of pathological grief. 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 scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG scores less than or equal to 25. Higher scores result in higher likelihood of CG.
Brief Grief Questionnaire (BGQ)
Time frame: At 6 months post death
A self reporting instrument assessing complicated grief. A total of 5 questions on a 3 point scale. A total score of 10 is possible. Higher scores result in higher likelihood of CG.
Impact of Events Scale - Revised (IES-r)
Time frame: At 6 months post death
A self reporting instrument that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales. Higher scores are linked with a greater likelihood of distress
Patient Health Questionnaire-9 (PHQ-9)
Time frame: At 6 months post death
A multipurpose instrument for screening for severity of depression. A total of 9 questions. Respondents answer from "0" to "4" for each question. The total range is from 0 to 36. A higher score is correlated with greater level of depression.
Bereavement Dependency Scale (BDS)
Time frame: At 6 months post death
Used as a predictor of enduring and complicated grief. A total of 6 questions. Items are rated on a 5 point scale from "1" to "5". A higher score is linked to dependency on deceased.
Results and safety
The study was stopped early (reason given: The investigators experienced several barriers: including COVID-19 delays on research, high staff turnover, and burnout amongst ICU Nursing Staff. The study team and ICU staff determined low feasibility of completing Phase 2, 3, and 4 as a result.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No. All participant data will be kept securely by the research team and de-identified for any future publication.
Related trials for Severe Grief Reaction
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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 principal investigator
Physician
Brandi Vanderspank-Wright, Phd,RN principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with 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 2 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: stopped early, 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?
The study was stopped early (reason given: The investigators experienced several barriers: including COVID-19 delays on research, high staff turnover, and burnout amongst ICU Nursing Staff. The study team and ICU staff determined low feasibility of completing Phase 2, 3, and 4 as a result.). Results are not available in the source record.
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 of Complicated Grief-Revised (ICG-r) (time frame: At 6 months post death). The study lists 5 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.