<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210727052001N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-29</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The Effectiveness of Cognitive Rehabilitation Therapy in Schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Cognitive Rehabilitation on Frontal Network Functional Connectivity in Schizophrenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57869</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The way to randomize the research is as follows: The first step is to create a random sequence. Simple randomization will be used in this research. Randomization based on a single sequence of random assignments is called simple randomization. The randomization unit in this research is individual. There are various randomization tools for this type of randomization, in this research, the table of random numbers is used. The table of random numbers is a collection of numbers that are generated without a pattern and in a certain order, completely randomly, and are put in the form of a table. How to make a random sequence is as follows: First, we determine the direction of reading the numbers, which are two from the top. The numbers for the different groups considered here are as follows: even numbers obtained from this table are assigned to the control group and odd numbers to the intervention group. Then we place our finger on one of the table numbers and act according to the described process (i.e. we move up 2) and record the numbers and assign them to the control or intervention group according to whether they are odd or even. to give In the next stage, which is called concealment, which refers to the method used to perform a random sequence on the subjects, so that the allocated group is not known before the allocation of the individual. For concealment in this research, non-transparent sealed envelopes or random sequence will be used. In this method, first, the random sequence, which is here by the table of random numbers, is performed. Then, based on the sample size (30 people), a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. At the end, the lids of the envelopes are glued and placed in a box. At the time of the registration of subjects, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive rehabilitation therapy. First, a psychiatric interview and a Panss questionnaire are used to enter this group to confirm schizophrenia. Then, in order to evaluate the functional connections of the frontal network, patients in this group have an electroencephalogram (eeg); Also, N_back and Wisconsin tests are taken before the intervention to check working memory performance and executive functions. Immediately after the initial assessments, the first session of cognitive rehabilitation practice is performed. The number of sessions is 16 sessions 2 times a week, which takes a total of 8weeks. In each training session, the patient performs a set of cognitive rehabilitation exercises using Captain Log software. The time required for each exercise is 2 to 3 minutes. Each training session is 45 minutes for each subject. This program is adaptively designed so that the process and difficulty of the program matches the capacity and ability of each person individually, but after the start of training, the degree of difficulty automatically increases. This training program is designed in such a way that in each section, by providing appropriate visual and audio feedback and recording the scores and timing of each step, the person is guided step by step. Intervention 2: Control group: The members of the control group are first selected by psychiatric interview and Panss questionnaire and then a eeg is received from them to check the functional communication of the frontal network and a pre-test is taken from them by N_back and Wisconsin tests. After 7 weeks and without any intervention, they will be measured again by the same instruments and the post-test will be performed.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All research data is available under the title of the article and thesis.

When:
Access period starts 6 months after the results are published.

To whom:
Everyone for whom the data is useful and usable has to access it.

Conditions:
To be aware of results and reference.

Where to obtain:
Visit the Central library of the University of Social Welfare and Rehabilitation Science. 
Address: Tehran, Daneshjoo Blvd., Koodkiar St., University of Social Welfare and Rehabilitation Science.
Phone number: 0098 021 71732818

How to obtain:
After visiting or calling the library of the University of Social Welfare and Rehabilitation Science the desired data will be provided to you.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Motahareh Eslamnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshvaran Building. ,Alley 3., Farzanegan St., Chamran St., Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194894316</zip>
        <telephone>+98 71 3626 8255</telephone>
        <email>mot.eslamnejad@USWR.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Motahareh Eslamnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshvaran Building., Alley 3., Farzanegan St., Chamran St., Shiraz</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194894316</zip>
        <telephone>+98 71 3626 8255</telephone>
        <email>mot.eslamnejad@USWR.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range between 18 and 45 years
Ability to communicate and answer questions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of brain injury
History of brain disorder
Changes in antipsychotic treatment in the last 1 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cognitive rehabilitation therapy. First, a psychiatric interview and a Panss questionnaire are used to enter this group to confirm schizophrenia. Then, in order to evaluate the functional connections of the frontal network, patients in this group have an electroencephalogram (eeg); Also, N_back and Wisconsin tests are taken before the intervention to check working memory performance and executive functions. Immediately after the initial assessments, the first session of cognitive rehabilitation practice is performed. The number of sessions is 16 sessions 2 times a week, which takes a total of 8weeks. In each training session, the patient performs a set of cognitive rehabilitation exercises using Captain Log software. The time required for each exercise is 2 to 3 minutes. Each training session is 45 minutes for each subject. This program is adaptively designed so that the process and difficulty of the program matches the capacity and ability of each person individually, but after the start of training, the degree of difficulty automatically increases. This training program is designed in such a way that in each section, by providing appropriate visual and audio feedback and recording the scores and timing of each step, the person is guided step by step.</i_keyword>
      <i_keyword>Control group: The members of the control group are first selected by psychiatric interview and Panss questionnaire and then a eeg is received from them to check the functional communication of the frontal network and a pre-test is taken from them by N_back and Wisconsin tests. After 7 weeks and without any intervention, they will be measured again by the same instruments and the post-test will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frontal Functional Connectivity. Timepoint: Before the start of the intervention and 2 weeks after the end of the intervention. Method of measurement: Electroencephalography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-17</approval_date>
        <contact_name>Ethics committee of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>University of Social Welfare and Rehabilitation Sciences., koodakyar street., velenjak Blvd., Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
