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临床试验/NCT05956405
NCT05956405已完成不适用

Retraining of the Amygdala and Insula for the Treatment of Persistent Covid

Hospital Miguel Servet2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Short Form de 36 items (SF-36)

研究概览

简要总结

Prolonged COVID, also known as post-COVID or Sar-CoV-2 infection with post-acute sequelae, refers to a set of multi-organ symptoms that persist in patients who have suffered SARS-CoV-2 infection, even after of the acute phase of the disease. Approximately 10% of people experience this set of symptoms after their acute COVID has resolved. Such symptoms may include respiratory problems, myalgia, extreme fatigue, moodiness, cognitive impairment, and difficulty sleeping.

Psychological therapies, such as mindfulness, have already demonstrated their effectiveness in pathologies of this type, improving mental health and physical function, as well as reinforcing acceptance and reducing symptoms. Specifically, amygdala-insula training was originally designed for patients with chronic fatigue syndrome as a method of reducing chronic over-sensitization and heightened fear response of the amygdala, which may be behind some of the symptoms related to both with this pathology as with fibromyalgia.

A lot of research is currently being done on different types of treatments such as pharmaceutical, biological, dietary, homeopathic and rehabilitation for the treatment of persistent COVID; however, an effective treatment has not yet been found. Therefore, this study aims to evaluate the impact of a retraining intervention of the amygdala and insula for the improvement of the quality of life of patients with persistent COVID.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

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

  • Age: 18-30 years old.
  • Grant informed consent.
  • Diagnosis of persistent COVID by primary care physicians.

排除标准

  • Age: <18 years old
  • Serious medical or psychiatric illnesses

结局指标

主要结局

Short Form de 36 items (SF-36)

时间窗: Three-months follow-up

In the AIR + Mindfulness program group

次要结局

  • General Anxiety Disorder-7 (GAD-7)(Three-months follow-up)
  • Patient Health Questionnaire (PHQ-9)(Three-months follow-up)
  • Emotional Regulation Questionnaire (ERQ)(Three-months follow-up)
  • Acceptance and Action Questionnaire-II (AAQ-II)(In the relaxation program group)
  • Sociodemographic data Gender, age, marital status, education, occupation, economical level(Baseline)
  • Spanish Chronic Pain Grading Scale(Three-months follow-up)
  • Pain Catastrophizing Scale (PCS)(Three-months follow-up)
  • Modified Fatigue Impact Scale (MFIS)(Three-months follow-up)
  • Insomnia Severity Index (ISI)(Three-months follow-up)
  • Memory failures of Everyday (MFE)(Three-months follow-up)
  • Five Facets of Mindfulness Questionnaire (FFMQ)(Three-months follow-up)

研究者

发起方
Hospital Miguel Servet
申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Garcia Campayo

Principal Investigator

Hospital Miguel Servet

研究点 (2)

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