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

COVID-19 Caregiver Emotional Support

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.

Study Overview

• Status: Completed
• Conditions: COVID; Posttraumatic Stress Disorder; Prolonged Grief Disorder
• Intervention / Treatment: Behavioral: Tele-delivered psychological intervention

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Skejby Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Horsens, Denmark
    • Hospitalsenheden Vest, Horsens
  • Hvidovre, Denmark
    • Hvidovre Hospital
  • Kolding, Denmark
    • Sygehus Lillebælt, Kolding
  • Odense, Denmark
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tele-delivered psychological intervention; Weekly tele-delivered psychological intervention

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Penn State Worry Questionnaire (3 items)	Worry, min. score 3, max score 15, higher score corresponds to greater worry	Baseline to 1, 6, and 12/13 months
Brooding subscale of Ruminative Responses Scale	Brooding, min. score 5, max score 20, higher score corresponds to greater brooding/rumination	Baseline to 1, 6, and 12/13 months
Intolerance of uncertainty Scale (2 item)	Intolerance of uncertainty, min score 2, max score 8, greater score indicates greater uncertainty intolerance	Baseline to 1, 6, and 12/13 months

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Annika von Heymann, PhD, Department of Oncology, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Informal caregiver
• Additional Relevant MeSH Terms: Mental Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; COVID-19; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: P-2020-544; 0216-00030B (Other Grant/Funding Number: Independent Research Fund Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No