<?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>IRCT20161026030510N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-07</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of cognitive rehabilitation intervention on the improvement of cognitive deficits (working memory and selective attention) and quantitative electroencephalogram (QEEG) indices in men with heroin and methamphetamine use disorders</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of cognitive rehabilitation intervention on the improvement of cognitive deficits (working memory and selective attention) and quantitative electroencephalogram (QEEG) indices in men with heroin and methamphetamine use disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60802</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Men with Heroin Disorder - Men with Methamphetamine Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Methamphetamine (n=20) group is assessed by structured clinical interview (DSM-5) for Axis I and II disorders. They are then assessed (pre-test) through attention tests (Stroop test) and memory (Wechsler memory test). After the initial assessment (completion of attention and memory tests and EEG recording), 12 sessions of RehaCom cognitive rehabilitation intervention are performed. Also, patients will be re-evaluated ((post-test) two months after the end of the interventions (follow up). Intervention 2: The heroin group (n = 20) is assessed by structured clinical interview (DSM-5) for Axis I and II disorders. They are then assessed (pre-test) through attention tests (Stroop test) and memory (Wechsler memory test). After the initial assessment (completion of attention and memory tests and EEG recording), 12 sessions of RehaCom cognitive rehabilitation intervention are performed. Also, patients will be re-evaluated ((post-test) two months after the end of the interventions (follow up).</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:
Clinical and cognitive outcomes of patients after the intervention

When:
2022

To whom:
Researchers

Conditions:
Researchers from all scientific centers

Where to obtain:
Email

How to obtain:
Email - 4 Weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Reza Arezoomandan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mansouri St, Faculty of Behavioral Sciences and Mental Health</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>Arezoomandan@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Reza Arezoomandan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>خیابان منصوری، دانشکده علوم رفتاری و سلامت روان</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 6655 1555</telephone>
        <email>Arezoomandan@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-Men with a minimum age of 20 years and a maximum of 50 year- Having at least secondary education (cycle) - Having diagnostic criteria for dependence on opiates (heroin) and stimulants (methamphetamine - Have lower than average scores on attention and memory tests based on initial assessment using RehaCom cognitive software screening modules - No participating in psychotherapy groups including NA in the last 6 months - Complete the informed consent form</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>- Having any psychiatric disorder except for drug-related disorders - Traumatic brain injuries (medium to severe) along with neurologic deficits or suffering from acute and unstable medical conditions - having serious suicidal thoughts - Receiving another medical or psychological intervention at the same time</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Methamphetamine (n=20) group is assessed by structured clinical interview (DSM-5) for Axis I and II disorders. They are then assessed (pre-test) through attention tests (Stroop test) and memory (Wechsler memory test). After the initial assessment (completion of attention and memory tests and EEG recording), 12 sessions of RehaCom cognitive rehabilitation intervention are performed. Also, patients will be re-evaluated ((post-test) two months after the end of the interventions (follow up).</i_keyword>
      <i_keyword>The heroin group (n = 20) is assessed by structured clinical interview (DSM-5) for Axis I and II disorders. They are then assessed (pre-test) through attention tests (Stroop test) and memory (Wechsler memory test). After the initial assessment (completion of attention and memory tests and EEG recording), 12 sessions of RehaCom cognitive rehabilitation intervention are performed. Also, patients will be re-evaluated ((post-test) two months after the end of the interventions (follow up).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Selective Attention. Timepoint: Before and after the intervention. Method of measurement: Stroop test.</prim_outcome>
      <prim_outcome>Quantitative Electroencephalogram (QEEG) Indices. Timepoint: Before and after the intervention. Method of measurement: QEEG 3840  -Neuroguide software.</prim_outcome>
      <prim_outcome>Working memory. Timepoint: Before and after the intervention. Method of measurement: Wechsler Memory Scale-Third Edition (WMS-III).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-27</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences,Shahid Hemmat Highway; Next to Milad Tower Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
