Clinical trial NCT04409821: Tele-based Psychological Emotional Support for Informal CARegivers of COVID-19 Patients in Intensive Care
Official title: COVID-19 Caregiver Emotional Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Prolonged Grief Disorder
COVID
Keywords: Informal caregiver
COVID-19
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Recruitment rate
timeFrame: At inclusion
measure: Completion rate
timeFrame: During and post-intervention (1 month)
measure: Peri-traumatic distress inventory (negative emotions)
timeFrame: Pre-post intervention (1 month after discharge/death)
measure: Impact of Events Scale (6 item)
timeFrame: 1 month post intervention
measure: Impact of Events Scale (6 item)
timeFrame: 6 months post intervention
measure: Impact of Events Scale (6 item)
timeFrame: 12/13 months post intervention
Secondary outcomes:
measure: Prolonged Grief-13-scale
timeFrame: 6 and 13 months
measure: PROMIS Depression (8 item scale)
timeFrame: Baseline to 1, 6, and 12/13 months
measure: PROMIS Anxiety (8 item scale)
timeFrame: Baseline to 1, 6, and 12/13 months
measure: Perceived Stress Scale (4 item)
timeFrame: Baseline to 1, 6, and 12/13 months
Other outcomes:
measure: Short Penn State Worry Questionnaire (3 items)
timeFrame: Baseline to 1, 6, and 12/13 months
measure: Brooding subscale of Ruminative Responses Scale
timeFrame: Baseline to 1, 6, and 12/13 months
measure: Intolerance of uncertainty Scale (2 item)
timeFrame: Baseline to 1, 6, and 12/13 months
Locations:
city: Aarhus
country: Denmark
facility: Skejby Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Horsens
country: Denmark
facility: Hospitalsenheden Vest, Horsens
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Kolding
country: Denmark
facility: Sygehus Lillebælt, Kolding
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Department of Oncology, Rigshospitalet, Denmark
name: Annika von Heymann, PhD
role: PRINCIPAL_INVESTIGATOR
References: