<?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>IRCT20180317039116N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-28</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effects of computer-assisted cognitive rehabilitation on cognitive functions, and mental health of people with schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effects of computer-assisted cognitive rehabilitation on cognitive functions, and mental health of people with schizophrenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66415</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: The simple randomization method using random number tables will be used. for allocation concealment Sequentially numbered, sealed, opaque envelopes will be used for this process: The random numbers are placed in the opaque envelopes and the allocation of these opaque envelopes to groups is done randomly, this allocation is confidential and without informing the executor, patient, and investigators, Blinding description: All patients are informed that they consent to participate in a research study. A written consent form will be completed by the participants. Statisticians, assessors , and participants are blinded to grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>Cognitive impairments in Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving conventional services (doctor, psychologist, and occupational therapist consultation), this group receives computerized cognitive rehabilitation 3 days a week (30 sessions in total). Using the CANTAB cognitive test set, computerized cognitive rehabilitation is performed in 45-minute sessions. This rehabilitation includes the practice of 4 subtests DMS, MTS, OTS, and PRM from CANTAB, which becomes more complex as time passes. For example, as the stage increases, the number of variables and response time changes, and it is expected that the accuracy and speed of the person's action will be affected accordingly. The purpose of  DMS, MTS, and PRM exercises is to involve several cognitive processes related to memory and visual-spatial attention. OTS targets planning, problem-solving, and executive functions. All the people in this group are evaluated cognitively and psychologically before, immediately after, and two months after the interventions, in order to evaluate the effectiveness of the intervention in improving the cognitive and mental health of people. Intervention 2: Control group: Participants in this group will receive treatment as usual such as psychiatrist, psychologist and occupational therapist visits for 30 sessions of 45 minutes (3 sessions per week).</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:
Sending all of the data, if the members of the research team agree, a decision will be made based on the applicant's goal.

When:
The second half of 1402

To whom:
First author and corresponding author

Conditions:
If the members of the research team agree, a decision will be made based on the applicant's goal.

Where to obtain:
Elahe Fathi Azar

How to obtain:
Sending an email to Elahe Fathi Azar

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hooshang Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>university of social welfare and rehabilitation sciences</address>
        <city>تهران</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۳۴</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>Elahe_fathi91@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hooshang Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>university of social welfare and rehabilitation sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۳۴</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>Elahe_fathi91@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Schizophrenia disorder diagnosed based on DSM-V by a psychiatrist
Having an MMSE score above 18
Age 18 to 55 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having mental retardation
Orthopedic, neurological problems that prevent upper limb function
Changing the medication regimen during the last month or during the intervention
Having paranoid delusions</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>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to receiving conventional services (doctor, psychologist, and occupational therapist consultation), this group receives computerized cognitive rehabilitation 3 days a week (30 sessions in total). Using the CANTAB cognitive test set, computerized cognitive rehabilitation is performed in 45-minute sessions. This rehabilitation includes the practice of 4 subtests DMS, MTS, OTS, and PRM from CANTAB, which becomes more complex as time passes. For example, as the stage increases, the number of variables and response time changes, and it is expected that the accuracy and speed of the person's action will be affected accordingly. The purpose of  DMS, MTS, and PRM exercises is to involve several cognitive processes related to memory and visual-spatial attention. OTS targets planning, problem-solving, and executive functions. All the people in this group are evaluated cognitively and psychologically before, immediately after, and two months after the interventions, in order to evaluate the effectiveness of the intervention in improving the cognitive and mental health of people.</i_keyword>
      <i_keyword>Control group: Participants in this group will receive treatment as usual such as psychiatrist, psychologist and occupational therapist visits for 30 sessions of 45 minutes (3 sessions per week).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual memory: Visual memory is a type of memory that refers to the ability to recall or remember activities, images, positions of objects or words in the past. Visual memory includes the ability to store and retrieve visual sensations and perceptions previously experienced by the individual. Timepoint: Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the intervention period. Method of measurement: PAL, SRM, SWM, and SSP subtests of CANTAB.</prim_outcome>
      <prim_outcome>Problem Solving: Problem solving is part of thinking. Problem solving, which is considered the most complex part of any intellectual operation, is defined as an important cognitive process that requires the integration and control of a series of basic and ordinary skills. Timepoint: Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the intervention period. Method of measurement: SOC subtest of CANTAB.</prim_outcome>
      <prim_outcome>Self-esteem: Self-esteem is the belief that a person has about her worth and importance. Timepoint: Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the intervention period. Method of measurement: Using Cooper-Smith self-esteem inventory (SEI).</prim_outcome>
      <prim_outcome>Mental health is a fundamental and comprehensive factor in the health and life of every person. The World Health Organization (WHO) states:"Health means physical, mental and social well-being and not merely the absence of disease or disability".An important application of this definition is that mental health is more than just the absence of mental disorders or disabilities. Timepoint: Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the. Method of measurement: Warwick-Edinburgh Mental Well-Being Scale.</prim_outcome>
      <prim_outcome>Meaningful activities are related to mental health and well-being. Timepoint: Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the. Method of measurement: Engagement in Meaningful Activities Survey (EMAS).</prim_outcome>
      <prim_outcome>Recovery is not just the disappearance of symptoms, but also includes supporting the individual to live a meaningful life. Timepoint: Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the. Method of measurement: Recovery Assessment Scale – Domains and Stages (RAS-DS).</prim_outcome>
      <prim_outcome>Basic psychological needs include autonomy, relatedness, and competence. Timepoint: Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the. Method of measurement: Basic Needs Satisfaction in General Scale (BPNSG-S).</prim_outcome>
      <prim_outcome>A general mental health assessment is essential to assess the experience of psychiatric problems. Timepoint: Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the. Method of measurement: General Health Questionnaire (GHQ-12).</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>2023-01-24</approval_date>
        <contact_name>Ethics Committee of University of social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>University of social welfare and rehabilitation sciences, Kodakyar Alley, Daneshjo Blv. Evin, Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
