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

August 5, 2023 updated by: Allaa Ashraf Maher Mohammed Elfwey, Cairo University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 4240101
        • Faculty of physical therapy .Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Other Names:
  • cognitive behavioral therapy
Active Comparator: 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
Behavioral: 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.
Other Names:
  • cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The MMSE is easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
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.
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
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.
easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Hossam M Mohammed, PHD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

August 5, 2023

First Submitted That Met QC Criteria

August 5, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 5, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rehacom on post covid

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-COVID-19 Syndrome

Clinical Trials on rehacom

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe