xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981872</url>
    </required_header>
    <id_info>
      <org_study_id>Rehacom on post covid</org_study_id>
      <nct_id>NCT05981872</nct_id>
    </id_info>
    <brief_title>EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19</brief_title>
    <official_title>EFFECT OF COGNITIVE BEHAVIORAL THERAPY ON DEPRESSION AND QUALITY OF LIFE IN PATIENTS WITH POST COVID-19</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test the effect of Rehacom on depression and Quality of&#xD;
        life in post covid -19 patients. The main question it aims to answer is:&#xD;
  &#xD;
        • Is a cognitive rehabilitation therapy will improve depression and quality of life in&#xD;
        patients with post COVID-19? Researchers will compare Rehacom with exercise therapy to see if&#xD;
        rehacom can improve depression and quality of life in patients with post COVID-19&#xD;
        neuropsychological problems.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Purpose of the study:&#xD;
  &#xD;
          -  To investigate the effect of cognitive rehabilitation therapy on depression in post&#xD;
             COVID-19 patients.&#xD;
  &#xD;
          -  To investigate the effect of cognitive rehabilitation therapy on quality of life in post&#xD;
             COVID-19 patients.&#xD;
  &#xD;
        Significance of the study:&#xD;
  &#xD;
        •There is growing evidence that individuals with COVID-19 disease can develop a range of&#xD;
        neurological complications including cognitive and neuropsychiatric symptoms . Cognitive&#xD;
        rehabilitation essential in improving quality of life with Introduction of new&#xD;
        neuropsychological rehabilitation tools based on the latest developments in computer&#xD;
        sciences.&#xD;
  &#xD;
        This study aims to investigate the RehaCom as a cognitive rehabilitation program on&#xD;
        depression and quality of life in patients suffer from post COVID-19 neuropsychological&#xD;
        problems.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">May 4, 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Study group (A) which will include 18 patients who will receive cognitive rehabilitation (Rehacom ) and selected physical therapy program.&#xD;
  Control group (B) which will include 18 patients who will receive only selected physical therapy program</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Mini- Mental State Examination (MMSE)</measure>
      <time_frame>The MMSE is easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck depression inventory (BDI)</measure>
      <time_frame>easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>.Katz Index of Independence in Activities of Daily Living</measure>
      <time_frame>easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual</time_frame>
      <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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Post-COVID-19 Syndrome</condition>
    <arm_group>
      <arm_group_label>post covid-19 patients with neurological symptoms as study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>post covid-19 patients with neurological symptoms as control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Control group (B) which will include 18 patients who will receive only selected physical therapy program (that included aerobic, strength, and balance training ).&#xD;
  The treatment will conducted for 60 minutes, 3 sessions per week for 12 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>rehacom</intervention_name>
      <description>Rehacom was carried out at the cognition laboratory at Faculty of physical therapy, Cairo University for training of figural memory, attention concentration.&#xD;
  Attention concentration training consists of 24 levels of difficulties .&#xD;
  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.</description>
      <arm_group_label>post covid-19 patients with neurological symptoms as control group</arm_group_label>
      <arm_group_label>post covid-19 patients with neurological symptoms as study group</arm_group_label>
      <other_name>cognitive behavioral therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients will be selected according to following criteria:&#xD;
  &#xD;
                 1. Patients from both genders (male and female).&#xD;
  &#xD;
                 2. The age of participants ranged from 30 to 45 years .&#xD;
  &#xD;
                 3. The patients had score more than 24 according to Mini mental state examination&#xD;
                    (MMSE).&#xD;
  &#xD;
                 4. Patient muscle power not less than grade 3 .&#xD;
  &#xD;
                 5. Patients are ambulant.&#xD;
  &#xD;
                 6. Patients with confirmation of previous covid19 infection PCR TEST.&#xD;
  &#xD;
                 7. Participants were required to live in Egypt during the pre-covid and COVID-19&#xD;
                    pandemic.&#xD;
  &#xD;
                 8. Patients meeting the guide line of world health organization (WHO) of&#xD;
                    long/post-covid 19 syndromes.&#xD;
  &#xD;
                 9. Patients are &quot;long-haulers&quot; those who history of probable or confirmed SARS-CoV-2&#xD;
                    infection; usually within three months from the onset of COVID-19, and last more&#xD;
                    than two months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patients will be excluded if they have any of the following:&#xD;
  &#xD;
                 1. Patient previously diagnosed with depression and currently taking medication.&#xD;
  &#xD;
                 2. patient had prior cognitive impairment.&#xD;
  &#xD;
                 3. Illiterate patients.&#xD;
  &#xD;
                 4. patient had experienced another major stressful event (e.g., divorce,&#xD;
                    bereavement) in the past year.&#xD;
  &#xD;
                 5. Checking comorbidities (sum of hypertension, diabetes, arrhythmia, myocardial&#xD;
                    infarction, Chronic Obstructive Pulmonary Disease/Asthma.&#xD;
  &#xD;
                 6. Mild cognitive impairment, dementia, other neurodegenerative diseases, stroke,&#xD;
                    depression,&#xD;
  &#xD;
                 7. Osteoarthritis , low back pain and prevalence of polypharmacy (5 or more drugs)&#xD;
                    at admission.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hossam M Mohammed, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of physical therapy .Cairo university</name>
        <address>
          <city>Cairo</city>
          <zip>4240101</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Allaa Ashraf Maher Mohammed Elfwey</investigator_full_name>
      <investigator_title>physical therapist</investigator_title>
    </responsible_party>
    <keyword>Rehacom</keyword>
    <keyword>post covid-19</keyword>
    <keyword>cognitive rehabilitation</keyword>
    <keyword>depression</keyword>
    <keyword>Quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981872
  org study id: Rehacom on post covid
  nct id: NCT05981872
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  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
  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.
  measure: Beck depression inventory (BDI)
  time frame: easily administered and requires only 5-10 minutes to complete depending on the impairment of the individual
  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.
  measure: .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
  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.
  arm group label: post covid-19 patients with neurological symptoms as study group
  arm group type: Experimental
  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 group label: post covid-19 patients with neurological symptoms as control group
  arm group type: Active Comparator
  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: rehacom
  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.
  arm group label: post covid-19 patients with neurological symptoms as control group
  arm group label: post covid-19 patients with neurological symptoms as study group
  other name: cognitive behavioral therapy
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hossam M Mohammed, PHD
  role: Principal Investigator
  affiliation: Cairo University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Allaa Ashraf Maher Mohammed Elfwey
  investigator title: physical therapist
  mesh term: COVID-19
  mesh term: Depression