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

NCT04409821 | Completed

• 2 other identifiers: P-2020-5440216-00030B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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.

Conditions

Posttraumatic Stress Disorder; Prolonged Grief Disorder; COVID

Keywords

Informal caregiver; COVID-19

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Prolonged Grief-13-scale

  6 and 13 months

• PROMIS Depression (8 item scale)

  Baseline to 1, 6, and 12/13 months

• PROMIS Anxiety (8 item scale)

  Baseline to 1, 6, and 12/13 months

• Perceived Stress Scale (4 item)

  Baseline to 1, 6, and 12/13 months

Other Outcomes (3)

• Short Penn State Worry Questionnaire (3 items)

  Baseline to 1, 6, and 12/13 months

• Brooding subscale of Ruminative Responses Scale

  Baseline to 1, 6, and 12/13 months

• Intolerance of uncertainty Scale (2 item)

  Baseline to 1, 6, and 12/13 months

Study Arms (1)

Tele-delivered psychological intervention

EXPERIMENTAL

Weekly tele-delivered psychological intervention

Behavioral: Tele-delivered psychological intervention

Interventions

Tele-delivered psychological intervention BEHAVIORAL

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.

Tele-delivered psychological intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (6)

Skejby Hospital

Aarhus, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hospitalsenheden Vest, Horsens

Horsens, Denmark

Location

Hvidovre Hospital

Hvidovre, Denmark

Location

Sygehus Lillebælt, Kolding

Kolding, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Prolonged Grief Disorder; COVID-19

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Annika von Heymann, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Model Details: Feasibility study

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 1, 2020
• Study Start: May 29, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)