<?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>IRCT20101130005280N36</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-05</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effects of computer tasks on improvement of cognitive functions in schizophrenic patients</public_title>
      <acronym></acronym>
      <scientific_title>Effects of cognitive rehabilitation based on computer tasks on cognitive dysfunction in  patients with Schizophrenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55471</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The envelopes will be prepared by one of the members of the research team and the random numbers generated by the ''www.randomization.com'' website will be printed and placed in each envelope. The envelopes are sealed and their contents are not visible from outside. At first, purpose of the study is explained for each participants and after filling out the consent form, each participant selects an envelope and opens it and based on its content, the participant will be placed in either control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In this group, patients who are in remission and stabilization phase of the disease receive the medication prescribed by the psychiatrist for eight weeks. Also, psycho-educational programs and classes for schizophrenic patients will be held twice a week for 8 weeks. Each session lasts 10 minutes and each week, one of the 8 topics of "introduction to schizophrenia, causes of the disease, treatment, ways to deal with the recurrence of the disease, dealing with hallucinations, problem-solving, cognitive improvement and leisure time" are explained. In addition, a 20-minute video containing images of landscapes will be played each session. Intervention 2: Intervention group: In this group, patients who are in remission and stabilization phase of the disease receive the medication prescribed by the psychiatrist for eight weeks. Also, psycho-educational programs and classes for schizophrenic patients will be held twice a week for 8 weeks. Each session lasts 10 minutes and each week, one of the 8 topics of "introduction to schizophrenia, causes of the disease, treatment, ways to deal with the recurrence of the disease, dealing with hallucinations, problem-solving, cognitive improvement and leisure time" are explained. In addition, cognitive exercises using Captain's Log computer software will be done twice a week for 20 minutes each session to develop cognitive skills. This software includes training on attention skills using "Drum Signals" and "Musical Pairs" tests and memory skills using "What's Next" and "Match Play" tests.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Relevant partners should be consulted to publish the data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahareh Hakimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebn-e-sina hospital. Hore Ameli blv.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8313491959</zip>
        <telephone>+98 51 1711 2540</telephone>
        <email>Hakimib971@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Farhad Faridhoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn-e-Sina Hospital, Hore Ameli blv.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8313491959</zip>
        <telephone>+98 51 3711 2721</telephone>
        <email>faridhoseinif@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with schizophrenia between 18 and 60 years
Patients must be deficient in several cognitive domains.
The patient has no other problem or psychiatric disorder.
The patient does not have a record of proven mental disability
The patient has not received Electroconvulsive therapy in the past year.
The patient has the ability to read and write.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and breastfeeding.</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In this group, patients who are in remission and stabilization phase of the disease receive the medication prescribed by the psychiatrist for eight weeks. Also, psycho-educational programs and classes for schizophrenic patients will be held twice a week for 8 weeks. Each session lasts 10 minutes and each week, one of the 8 topics of "introduction to schizophrenia, causes of the disease, treatment, ways to deal with the recurrence of the disease, dealing with hallucinations, problem-solving, cognitive improvement and leisure time" are explained. In addition, a 20-minute video containing images of landscapes will be played each session.</i_keyword>
      <i_keyword>Intervention group: In this group, patients who are in remission and stabilization phase of the disease receive the medication prescribed by the psychiatrist for eight weeks. Also, psycho-educational programs and classes for schizophrenic patients will be held twice a week for 8 weeks. Each session lasts 10 minutes and each week, one of the 8 topics of "introduction to schizophrenia, causes of the disease, treatment, ways to deal with the recurrence of the disease, dealing with hallucinations, problem-solving, cognitive improvement and leisure time" are explained. In addition, cognitive exercises using Captain's Log computer software will be done twice a week for 20 minutes each session to develop cognitive skills. This software includes training on attention skills using "Drum Signals" and "Musical Pairs" tests and memory skills using "What's Next" and "Match Play" tests.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive functions. Timepoint: At the beginning of the intervention, week 4, week 8 (end on intervention), week 12 &amp; week 20 after the intervention. Method of measurement: Stroop test.</prim_outcome>
      <prim_outcome>Memory. Timepoint: At the beginning of the intervention, week 4, week 8 (end on intervention), week 12 &amp; week 20 after the intervention. Method of measurement: Rey auditory verbal learning test and Rey–Osterrieth complex figure test.</prim_outcome>
      <prim_outcome>Attention. Timepoint: At the beginning of the intervention, week 4, week 8 (end on intervention), week 12 &amp; week 20 after the intervention. Method of measurement: Digit span test.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-25</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
