|D013313||Stress Disorders, Post-Traumatic NIH||0.19|
There is one clinical trial.
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.
Description: Rate of consent among informed eligible participantsMeasure: Recruitment rate Time: At inclusion
Description: Rates of completion of intervention sessions among participantsMeasure: Completion rate Time: During and post-intervention (1 month)
Description: Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distressMeasure: Peri-traumatic distress inventory (negative emotions) Time: Pre-post intervention (1 month after discharge/death)
Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distressMeasure: Impact of Events Scale (6 item) Time: 1 month post intervention
Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distressMeasure: Impact of Events Scale (6 item) Time: 6 months post intervention
Description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distressMeasure: Impact of Events Scale (6 item) Time: 12/13 months post intervention
Description: Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorderMeasure: Prolonged Grief-13-scale Time: 6 and 13 months
Description: Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptomsMeasure: PROMIS Depression (8 item scale) Time: Baseline to 1, 6, and 12/13 months
Description: Symptoms of anxiety, min. score 8, max score 40, higher score corresponds to worse symptomsMeasure: PROMIS Anxiety (8 item scale) Time: Baseline to 1, 6, and 12/13 months
Description: Perceived stress, min. score 0, max score 16, higher score corresponds to worse stressMeasure: Perceived Stress Scale (4 item) Time: Baseline to 1, 6, and 12/13 months
Description: Worry, min. score 3, max score 15, higher score corresponds to greater worryMeasure: Short Penn State Worry Questionnaire (3 items) Time: Baseline to 1, 6, and 12/13 months
Description: Brooding, min. score 5, max score 20, higher score corresponds to greater brooding/ruminationMeasure: Brooding subscale of Ruminative Responses Scale Time: Baseline to 1, 6, and 12/13 months
Description: Intolerance of uncertainty, min score 2, max score 8, greater score indicates greater uncertainty intoleranceMeasure: Intolerance of uncertainty Scale (2 item) Time: Baseline to 1, 6, and 12/13 months
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports