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

NCT ID: NCT05981872

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-04

Study Completion Date

2024-01-31

Brief Summary

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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

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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

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Post-COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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post covid-19 patients with neurological symptoms as study group

•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.

Group Type EXPERIMENTAL

rehacom

Intervention Type BEHAVIORAL

Rehacom 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.

post covid-19 patients with neurological symptoms as control group

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

Group Type ACTIVE_COMPARATOR

rehacom

Intervention Type BEHAVIORAL

Rehacom 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.

Interventions

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rehacom

Rehacom 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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cognitive behavioral therapy

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Allaa Ashraf Maher Mohammed Elfwey

physical therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hossam M Mohammed, PHD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of physical therapy .Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Rehacom on post covid

Identifier Type: -

Identifier Source: org_study_id

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