CovidResearchTrials by Shray Alag


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Tele-delivered psychological interventionWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (0)


Name (Synonyms) Correlation

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D013313 Stress Disorders, Post-Traumatic NIH 0.18
D004194 Disease NIH 0.17

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 COVID-19 Caregiver Emotional Support

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.

NCT04409821 Posttraumatic Stress Disorder Prolonged Grief Disorder COVID Behavioral: Tele-delivered psychological intervention
MeSH:Disease Stress Disorders, Post-Traumatic

Primary Outcomes

Description: Rate of consent among informed eligible participants

Measure: Recruitment rate

Time: At inclusion

Description: Rates of completion of intervention sessions among participants

Measure: 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 distress

Measure: 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 distress

Measure: 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 distress

Measure: 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 distress

Measure: Impact of Events Scale (6 item)

Time: 12/13 months post intervention

Secondary Outcomes

Description: Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder

Measure: Prolonged Grief-13-scale

Time: 6 and 13 months

Description: Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms

Measure: 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 symptoms

Measure: 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 stress

Measure: Perceived Stress Scale (4 item)

Time: Baseline to 1, 6, and 12/13 months

Other Outcomes

Description: Worry, min. score 3, max score 15, higher score corresponds to greater worry

Measure: 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/rumination

Measure: 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 intolerance

Measure: Intolerance of uncertainty Scale (2 item)

Time: Baseline to 1, 6, and 12/13 months


No related HPO nodes (Using clinical trials)