Back to resultsEFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19
Primary Purpose
Post-COVID-19 Syndrome
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
rehacom
Sponsored by
About this trial
This is an interventional treatment trial for Post-COVID-19 Syndrome focused on measuring Rehacom, post covid-19, cognitive rehabilitation, depression, Quality of life
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Faculty of physical therapy .Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
post covid-19 patients with neurological symptoms as study group
post covid-19 patients with neurological symptoms as control group
Arm Description
•Study group (A) will receive cognitive rehabilitation (Rehacom ) for 30 minutes and selected physical therapy program(that included aerobic, strength, and balance training for 30 minutes, with total duration 60 minutes. 3 sessions per week for 12 weeks.
Control group (B) which will include 18 patients who will receive only selected physical therapy program (that included aerobic, strength, and balance training ). The treatment will conducted for 60 minutes, 3 sessions per week for 12 weeks
Outcomes
Primary Outcome Measures
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.
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.
.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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05981872
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome
Keywords
Rehacom, post covid-19, cognitive rehabilitation, depression, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
post covid-19 patients with neurological symptoms as study group
Arm Type
Experimental
Arm Description
•Study group (A) will receive cognitive rehabilitation (Rehacom ) for 30 minutes and selected physical therapy program(that included aerobic, strength, and balance training for 30 minutes, with total duration 60 minutes. 3 sessions per week for 12 weeks.
Arm Title
post covid-19 patients with neurological symptoms as control group
Arm Type
Active Comparator
Arm Description
Control group (B) which will include 18 patients who will receive only selected physical therapy program (that included aerobic, strength, and balance training ).
The treatment will conducted for 60 minutes, 3 sessions per week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
rehacom
Other Intervention Name(s)
cognitive behavioral therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Mini- Mental State Examination (MMSE)
Description
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.
Time Frame
The MMSE is easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
Title
Beck depression inventory (BDI)
Description
• 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.
Time Frame
easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
Title
.Katz Index of Independence in Activities of Daily Living
Description
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.
Time Frame
easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hossam M Mohammed, PHD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy .Cairo university
City
Cairo
ZIP/Postal Code
4240101
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19
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