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

Posttraumatic Stress Disorder Clinical Trial

— CO-CarES  

Official title:

COVID-19 Caregiver Emotional Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409821
• Other study ID #: P-2020-544
• Secondary ID: 0216-00030B
• Status: Completed
• Phase: N/A
• Start date: May 29, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• COVID-19
• Posttraumatic Stress Disorder
• Prolonged Grief Disorder
• Stress Disorders, Post-Traumatic

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.

Locations

Country	Name	City	State
Denmark	Skejby Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Hospitalsenheden Vest, Horsens	Horsens
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Sygehus Lillebælt, Kolding	Kolding
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	Recruitment rate	Rate of consent among informed eligible participants	At inclusion
Primary	Completion rate	Rates of completion of intervention sessions among participants	During and post-intervention (1 month)
Primary	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)
Primary	Impact of Events Scale (6 item)	Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress	1 month post intervention
Primary	Impact of Events Scale (6 item)	Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress	6 months post intervention
Primary	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	Prolonged Grief-13-scale	Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder	6 and 13 months
Secondary	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
Secondary	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
Secondary	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