Post-COVID-19 SyndromeNCT05981872
EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19
A study testing rehacom in people with Post-COVID-19 Syndrome, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- rehacom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 4 May 2023to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- rehacom
- Keywords
- Rehacom, post covid-19, cognitive rehabilitation, depression, Quality of life
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehacomBehavioural
Also called cognitive behavioral therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| post covid-19 patients with neurological symptoms as study group | Experimental | •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. Receives: Behavioral: rehacom |
| post covid-19 patients with neurological symptoms as control group | Active comparator | 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 Receives: Behavioral: rehacom |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The MMSE is easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
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.
Measured: easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
.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.
Measured: easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start4 May 2023
- Primary completionSep 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allaa Ashraf Maher Mohammed Elfwey, Cairo University
- Investigators
- Hossam M Mohammed, PHD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981872
- Sponsor's protocol ID
- Rehacom on post covid
- Status last verified
- Aug 2023
- First submitted
- 5 Aug 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19
- ClinicalTrials.gov ID
- NCT05981872
- Acronym / sponsor ID
- Rehacom on post covid
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- Rehacom, post covid-19, cognitive rehabilitation, depression, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| post covid-19 patients with neurological symptoms as study group | Experimental | Behavioral: rehacom•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. |
| post covid-19 patients with neurological symptoms as control group | Active comparator | Behavioral: rehacomControl 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- All patients will be selected according to following criteria:
Key exclusion criteria (8 listed)
- The patients will be excluded if they have any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehacomAlso: cognitive behavioral therapyRehacom was carried out at the cognition laboratory at Faculty of physical therapy, Cairo University for training of figural memory, attention concentration. 1. Attention concentration training consists of 24 levels of difficulties . 2. 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. | Behavioural | post covid-19 patients with neurological symptoms as control group, post covid-19 patients with neurological symptoms as study group |
Primary outcome
The Mini- Mental State Examination (MMSE)
Time frame: 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.
Beck depression inventory (BDI)
Time frame: 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.
.Katz Index of Independence in Activities of Daily Living
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossam M Mohammed, PHD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehacom in people with Post-COVID-19 Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mini- Mental State Examination (MMSE) (time frame: The MMSE is easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.