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NCT03985592
ICU BEREAVE: Feasibility of a Multi-component Bereavement Support Intervention to Prevent Severe Grief Reaction
NA trial testing Education in Severe Grief Reaction in 12 participants. Terminated before completion.
7 February 2024
Quick facts
| Lead sponsor | Ottawa Hospital Research Institute |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 12 |
| Start date | 2 February 2020 |
| Primary completion | 7 February 2024 |
| Estimated completion | 7 February 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Education
Conditions studied
- Severe Grief Reaction — all drugs for Severe Grief Reaction →
Sponsor
Ottawa Hospital Research Institute
Who can join
18 and older, any sex, with Severe Grief Reaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03985592
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03985592 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ottawa Hospital Research Institute
- Last refreshed: 20 March 2025
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