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

Study Overview
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Brief Summary
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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.

Official Title
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COVID-19 Caregiver Emotional Support

Conditions
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Posttraumatic Stress Disorder, Prolonged Grief Disorder, COVID

Intervention / Treatment
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* Behavioral: Tele-delivered psychological intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-delivered psychological intervention<br>Weekly tele-delivered psychological intervention | Behavioral: Tele-delivered psychological intervention<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Informal caregiver, COVID-19