<?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>IRCT20181013041327N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-01</date_registration>
      <primary_sponsor>Cognitive Science  and Technologies Council</primary_sponsor>
      <public_title>Study the effect of tdcs and treatment of mindfulness in substance abuse disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effectiveness of Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) With and without Transcranial direct current stimulation (TDCS) on improve executive functions, emotional disregulation, craving and attention bias in relation to the stimuli in adolescent with Substance use disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34510</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For small study, you can use random digits table to sort people in groups.to use the random digits table, the participants in the study will be given a code or machine gun number, respectively. As many as 80 people will be selected. So the assigned codes and numbers will be two digits. To select sample individuals from the table, it will randomly start from a table point in the row or column direction. also,Individuals are randomly assigned to one of four study groups with the help of a random number table and receive the intervention of the same group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Substance use disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) With  Transcranial direct current stimulation (TDCS):The Package of Mindfulness Therapy (Hamletstein &amp; Saul, 2016) will be done in 12 sessions. Also, in the treatment of dTDCS, the dlpfc region will be stimulated by an active dose of 1/5 MA. Intervention 2: Intervention group: Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) Without  Transcranial direct current stimulation (TDCS): This group will only have a healing mindfulness package (Hamletstein &amp; Saul, 2016) during 12 sessions of therapy. Intervention 3: Intervention group: Transcranial direct current stimulation (TDCS): This group will receive only tdcs stimulation therapy. Intervention 4: sham group:  receiving sham tdcs.</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:
A behavioral data file, a study protocol, a informed consent form, and a clinical study report after unidentifiable individuals can be shared.

When:
The beginning of the access period is 1 year after the publication of the results.

To whom:
The behavioral data of this research will only be available to researchers working in academic and scientific institutions

Conditions:
Use of data is permitted only for articles related to the field of addiction.

Where to obtain:
Jaber Alizadeh Goradel, j.alizadeh45@gmail.com

How to obtain:
Researchers who want to access the data should receive a letter from the university at their place of work and send it to the responsible person's email address, in which case the data will be available to them in less than one month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jaber Alizadeh Goradel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Depatman of Clinical Psychology, Shahid Beheshti University, G.C. Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>756555557509</zip>
        <telephone>+98 21 2990 5309</telephone>
        <email>j.alizadeh45@gmail.com</email>
        <affiliation>The University of Shahid Beheshti</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jaber Alizadeh Goradel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Departman  of Clinical Psychology, Shahid Beheshti University, G.C. Evin,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>756555557509</zip>
        <telephone>+98 21 2990 5309</telephone>
        <email>j.alizadeh45@gmail.com</email>
        <affiliation>The University of Shahid Beheshti</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 18 to 21 years
Detection of substance abuse disorder based on DSM5 criteria
Be a boy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>21 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Taking psychiatric medications
Diagnosis of bipolar mood disorder or psychotic disorder based on DSM5 criteria
Intracranial implants
History of epilepsy and seizure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other psychoactive substance related disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) With  Transcranial direct current stimulation (TDCS):The Package of Mindfulness Therapy (Hamletstein &amp; Saul, 2016) will be done in 12 sessions. Also, in the treatment of dTDCS, the dlpfc region will be stimulated by an active dose of 1/5 MA.</i_keyword>
      <i_keyword>Intervention group: Mindfulness-Based Substance Abuse Treatment for Adolescents (MBSAT) Without  Transcranial direct current stimulation (TDCS): This group will only have a healing mindfulness package (Hamletstein &amp; Saul, 2016) during 12 sessions of therapy.</i_keyword>
      <i_keyword>Intervention group: Transcranial direct current stimulation (TDCS): This group will receive only tdcs stimulation therapy.</i_keyword>
      <i_keyword>sham group:  receiving sham tdcs</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Executive Functions. Timepoint: Before the intervention, after the intervention and three weeks after the intervention. Method of measurement: Wisconsin card sorting test, N-Back Test, Go/ No Go Task, Balloon Analogue Risk Taking Task.</prim_outcome>
      <prim_outcome>Emotional Disregulation. Timepoint: Before the intervention, after the intervention and three weeks after the intervention. Method of measurement: DERS.</prim_outcome>
      <prim_outcome>Craving. Timepoint: Before the intervention, after the intervention and three weeks after the intervention. Method of measurement: Craving Questionnaire(Franken &amp; etal).</prim_outcome>
      <prim_outcome>Attention Bias in relation to the stimuli. Timepoint: Before the intervention, after the intervention and three weeks after the intervention. Method of measurement: Dot-Probe Task.</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>Cognitive Science  and Technologies Council</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-01</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University</contact_name>
        <contact_address>Institute of Cognitive and Brain Sciences , Shahid Beheshti University, Shahid Shahriari Square, Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
