Clinical trial NCT05981872: EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19
Official title: EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Post-COVID-19 Syndrome
Keywords: Rehacom
post covid-19
cognitive rehabilitation
depression
Quality of life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study group (A) which will include 18 patients who will receive cognitive rehabilitation (Rehacom ) and selected physical therapy program.

Control group (B) which will include 18 patients who will receive only selected physical therapy program
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients will be selected according to following criteria:

  1. Patients from both genders (male and female).
  2. The age of participants ranged from 30 to 45 years .
  3. The patients had score more than 24 according to Mini mental state examination (MMSE).
  4. Patient muscle power not less than grade 3 .
  5. Patients are ambulant.
  6. Patients with confirmation of previous covid19 infection PCR TEST.
  7. Participants were required to live in Egypt during the pre-covid and COVID-19 pandemic.
  8. Patients meeting the guide line of world health organization (WHO) of long/post-covid 19 syndromes.
  9. 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

Exclusion Criteria:

* The patients will be excluded if they have any of the following:

  1. Patient previously diagnosed with depression and currently taking medication.
  2. patient had prior cognitive impairment.
  3. Illiterate patients.
  4. patient had experienced another major stressful event (e.g., divorce, bereavement) in the past year.
  5. Checking comorbidities (sum of hypertension, diabetes, arrhythmia, myocardial infarction, Chronic Obstructive Pulmonary Disease/Asthma.
  6. Mild cognitive impairment, dementia, other neurodegenerative diseases, stroke, depression,
  7. Osteoarthritis , low back pain and prevalence of polypharmacy (5 or more drugs) at admission.

Primary outcomes:
measure: The Mini- Mental State Examination (MMSE)
timeFrame: The MMSE is easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
measure: Beck depression inventory (BDI)
timeFrame: easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
measure: .Katz Index of Independence in Activities of Daily Living
timeFrame: easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy .Cairo university
Study officials:
affiliation: Cairo University
name: Hossam M Mohammed, PHD
role: PRINCIPAL_INVESTIGATOR
References: