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临床试验/NCT05981872
NCT05981872Enrolling By Invitation不适用

EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19

Cairo University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
36
试验地点
2
主要终点
The Mini- Mental State Examination (MMSE)

研究概览

简要总结

The goal of this clinical trial is to test the effect of Rehacom on depression and Quality of life in post covid -19 patients. The main question it aims to answer is:

• Is a cognitive rehabilitation therapy will improve depression and quality of life in patients with post COVID-19? Researchers will compare Rehacom with exercise therapy to see if rehacom can improve depression and quality of life in patients with post COVID-19 neuropsychological problems.

详细描述

Purpose of the study:

  • To investigate the effect of cognitive rehabilitation therapy on depression in post COVID-19 patients.
  • To investigate the effect of cognitive rehabilitation therapy on quality of life in post COVID-19 patients.

Significance of the study:

•There is growing evidence that individuals with COVID-19 disease can develop a range of neurological complications including cognitive and neuropsychiatric symptoms . Cognitive rehabilitation essential in improving quality of life with Introduction of new neuropsychological rehabilitation tools based on the latest developments in computer sciences.

This study aims to investigate the RehaCom as a cognitive rehabilitation program on depression and quality of life in patients suffer from post COVID-19 neuropsychological problems.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients will be selected according to following criteria:
  • Patients from both genders (male and female).
  • The age of participants ranged from 30 to 45 years .
  • The patients had score more than 24 according to Mini mental state examination (MMSE).
  • Patient muscle power not less than grade 3 .
  • Patients are ambulant.
  • Patients with confirmation of previous covid19 infection PCR TEST.
  • Participants were required to live in Egypt during the pre-covid and COVID-19 pandemic.
  • Patients meeting the guide line of world health organization (WHO) of long/post-covid 19 syndromes.
  • Patients are "long-haulers" those who history of probable or confirmed SARS-CoV-2 infection; usually within three months from the onset of COVID-19, and last more than two months

排除标准

  • The patients will be excluded if they have any of the following:
  • Patient previously diagnosed with depression and currently taking medication.
  • patient had prior cognitive impairment.
  • Illiterate patients.
  • patient had experienced another major stressful event (e.g., divorce, bereavement) in the past year.
  • Checking comorbidities (sum of hypertension, diabetes, arrhythmia, myocardial infarction, Chronic Obstructive Pulmonary Disease/Asthma.
  • Mild cognitive impairment, dementia, other neurodegenerative diseases, stroke, depression,
  • Osteoarthritis , low back pain and prevalence of polypharmacy (5 or more drugs) at admission.

结局指标

主要结局

The Mini- Mental State Examination (MMSE)

时间窗: The MMSE is easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual

The Mini- Mental State Examination (MMSE) was designed to provide a standardized, brief and practical assessment of cognitive status in geriatric patients. It is used as a brief screening tool for cognitive impairment and does not identify specific disorders. It concentrates only on the cognitive aspects of mental functions and excludes questions on mood, abnormal mental experiences as well as the form of thinking.

.Katz Index of Independence in Activities of Daily Living

时间窗: easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual

Katz ADL is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform activities of daily living independently. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding.

Beck depression inventory (BDI)

时间窗: easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual

• The BDI-II contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). Anxiety symptoms are not assessed but affective, cognitive, somatic, and vegetative symptoms are covered, reflecting the DSM-IV criteria for major depression. Scoring is achieved by adding the highest ratings for all 21 items. The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.

次要结局

未报告次要终点

研究者

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

Allaa Ashraf Maher Mohammed Elfwey

physical therapist

Cairo University

研究点 (2)

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