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

Post-COVID-19 Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05981872
• Other study ID #: Rehacom on post covid
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: January 2024

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: January 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Depression
• Post-COVID-19 Syndrome

Intervention

Behavioral:
• rehacom
Rehacom was carried out at the cognition laboratory at Faculty of physical therapy, Cairo University for training of figural memory, attention concentration. Attention concentration training consists of 24 levels of difficulties . Figural memory training consists of 9 levels of difficulties. In the training session, every patient was starting training from level one and when the patient successfully finished the level, the training then Progress to the level of difficulty.

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy .Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Mini- Mental State Examination (MMSE)	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.	The MMSE is easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
Primary	Beck depression inventory (BDI)	• 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.	easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
Primary	.Katz Index of Independence in Activities of Daily Living	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.	easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual