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Tele-based Psychological Emotional Support for Informal CARegivers of COVID-19 Patients in Intensive Care (CO-CarES)

Rigshospitalet logo

Rigshospitalet

Status

Completed

Conditions

Posttraumatic Stress Disorder
COVID
Prolonged Grief Disorder

Treatments

Behavioral: Tele-delivered psychological intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04409821
P-2020-544
0216-00030B (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Tele-delivered psychological intervention
Experimental group
Description:
Weekly tele-delivered psychological intervention
Treatment:
Behavioral: Tele-delivered psychological intervention

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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