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临床试验/NCT04409821
NCT04409821已完成不适用

COVID-19 Caregiver Emotional Support

Rigshospitalet, Denmark7 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
7
主要终点
Recruitment rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Recruitment rate

时间窗: At inclusion

Rate of consent among informed eligible participants

Completion rate

时间窗: During and post-intervention (1 month)

Rates of completion of intervention sessions among participants

Peri-traumatic distress inventory (negative emotions)

时间窗: Pre-post intervention (1 month after discharge/death)

Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress

Impact of Events Scale (6 item)

时间窗: 12/13 months post intervention

Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annika von Heymann

Postdoc

Rigshospitalet, Denmark

研究点 (7)

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