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

Not Applicable

Completed

• Conditions: Prolonged Grief Disorder; COVID; Posttraumatic Stress Disorder
• Interventions: Behavioral: Tele-delivered psychological intervention

• Registration Number: NCT04409821
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-28
• Study Start: 2020-05-29
• Study First Posted: 2020-06-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tele-delivered psychological intervention	Tele-delivered psychological intervention	Weekly tele-delivered psychological intervention

Primary Outcome Measures

Name	Time	Method
Recruitment rate	At inclusion	Rate of consent among informed eligible participants
Completion rate	During and post-intervention (1 month)	Rates of completion of intervention sessions among participants
Peri-traumatic distress inventory (negative emotions)	Pre-post intervention (1 month after discharge/death)	Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress
Impact of Events Scale (6 item)	12/13 months post intervention	Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

Secondary Outcome Measures

Name	Time	Method
Prolonged Grief-13-scale	6 and 13 months	Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder
PROMIS Depression (8 item scale)	Baseline to 1, 6, and 12/13 months	Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms
PROMIS Anxiety (8 item scale)	Baseline to 1, 6, and 12/13 months	Symptoms of anxiety, min. score 8, max score 40, higher score corresponds to worse symptoms
Perceived Stress Scale (4 item)	Baseline to 1, 6, and 12/13 months	Perceived stress, min. score 0, max score 16, higher score corresponds to worse stress

Trial Locations

Locations (6)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Skejby Hospital; 🇩🇰 Aarhus, Denmark

Sygehus Lillebælt, Kolding; 🇩🇰 Kolding, Denmark

Hospitalsenheden Vest, Horsens; 🇩🇰 Horsens, Denmark

Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark