Official Title
COVID-19 Caregiver Emotional Support
Brief Summary

The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.

Active, not recruiting
Posttraumatic Stress Disorder
Prolonged Grief Disorder
COVID

Behavioral: Tele-delivered psychological intervention

The intervention consists of two (or one, if preferred by caregivers) weekly tele-sessions during the ICU stay, lasting up to 30 minutes, and two sessions in the month after discharge from or death in the ICU. Sessions will be conducted via phone-calls or video-conferencing. Therapists will 1) validate caregivers' subjective experience, 2) normalize and psychoeducate about emotional reactions, and 3) offer emotion regulation drawing on contemporary cognitive treatment packages of decentering, acceptance and emotion tolerance. Sessions for bereaved caregivers will include psycho-education about grief, assessment of risk for adverse outcomes and information about available support, if needed. The intervention will be performed based on an intervention manual. The content of the intervention will be continually adapted and tailored to the needs of the participating caregivers by involving all caregivers in co-creating the intervention trough brief post-session interviews.

Eligibility Criteria

Inclusion Criteria:

- close relatives or friends of a patient hospitalized in an intensive care or
intermediary care wards with COVID-19

- capable of completing online questionnaires

- speak Danish sufficiently for a therapeutic dialogue

- provide informed consent

Exclusion Criteria:

- suffering from a severe psychiatric disorder (such as schizophrenia) or in ongoing
psychotherapeutic treatment for a psychiatric disorder (such as major depression
generalized anxiety disorder or others), that cannot be paused

- unable to complete verbal phone- or videoconferencing calls

- unable to complete electronic questionnaires

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Denmark
Locations

Skejby Hospital
Aarhus, Denmark

Rigshospitalet
Copenhagen, Denmark

Hospitalsenheden Vest, Horsens
Horsens, Denmark

Hvidovre Hospital
Hvidovre, Denmark

Sygehus Lillebælt, Kolding
Kolding, Denmark

Odense University Hospital
Odense, Denmark

Annika von Heymann, PhD, Principal Investigator
Department of Oncology, Rigshospitalet, Denmark

Rigshospitalet, Denmark
NCT Number
Keywords
Informal caregiver
Covid-19
MeSH Terms
COVID-19
Stress Disorders, Post-Traumatic