An interventional study of Tele-delivered psychological intervention in Posttraumatic Stress Disorder, Prolonged Grief Disorder and COVID, sponsored by Rigshospitalet, Denmark. Completed at 6 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Supportive care
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.
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This study's enrollment of 40 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
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Exclusion Criteria:
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.
Recruitment rate
Rate of consent among informed eligible participants
Time frame: At inclusion
Completion rate
Rates of completion of intervention sessions among participants
Time frame: 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
Time frame: 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
Time frame: 1 month post intervention
Impact of Events Scale (6 item)
Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress
Time frame: 6 months post intervention
Impact of Events Scale (6 item)
Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress
Time frame: 12/13 months post intervention
Prolonged Grief-13-scale
Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder
Time frame: 6 and 13 months
PROMIS Depression (8 item scale)
Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms
Time frame: 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
Time frame: 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
Time frame: Baseline to 1, 6, and 12/13 months
Short Penn State Worry Questionnaire (3 items)
Worry, min. score 3, max score 15, higher score corresponds to greater worry
Time frame: 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
Time frame: 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
Time frame: Baseline to 1, 6, and 12/13 months
Plan to share: No
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Rigshospitalet, Denmark