<?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>IRCT20200209046441N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-25</date_registration>
      <primary_sponsor>University of Mazandaran</primary_sponsor>
      <public_title>Mind-Based Cognitive Therapy and Transcranial Direct Electrical Stimulation on Brain-Behavioral Systems, Dark Personality Traits, and the Theory of mind Adolescents with high-risk behaviors and self-harm behaviors.</public_title>
      <acronym></acronym>
      <scientific_title>Compilation Of Effectiveness of Compassionate Mind-Based Cognitive Therapy and Transcranial Direct Electrical Stimulation on Brain-Behavioral Systems, Dark Personality Traits, and the Theory of mind Adolescents with high-risk behaviors.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53208</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 36 students with high-risk behaviors were randomly selected and then completely randomly (based on lottery) were divided two groups of 15 experiments and one group controls. Allocation was done through drawing a code in which every student was given a code and we put the codes in a container. Then 15 people who were taken out first were replaced in the first experimental group, 15 people later in the second experimental group and 18 people later in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Specific learning disability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: Transcranial Direct-Current Stimulation (tDCS) is a technique used to modify and modify brain function, which is now used as a healthy and effective procedure to treat most neurological conditions and even in medicine. Electrical Stimulation Technique A neural modification method that transmits electric current to a specific point in the skull over a very specific period of time, including an anode electrode that stimulates the nervous system and a cathode electrode that inhibits the nervous system. To stimulate the centers of the prefrontal cortex, this is responsible for controlling the complex movements of the anode electrode on the prefrontal cortex and the cathode electrode on the opposite shoulder (according to the 10-20 EEG system). Participants sit in a comfortable chair in a quiet room with no other sensory stimuli. Electrical stimulation of the brain by tDCS (Canadian-made Mind-Alif brand device) was instilled in students in a steady stream with a constant current of between 1.5 and 2 mA (intensity appropriate for client tolerance). Every other day and for 10 days, using a pair of 5×5 cm rubber electrodes covered with artificial sponge soaked in a normal saline solution and placed in the desired areas. Intervention 2: Control group: They did not receive any treatment. Intervention 3: Intervention group: Cognitive therapy based on a compassionate mind: Compassionate mind training is one of the psychotherapy methods in which empathy, empathy, compassion, acceptance and tolerance, responsibility and a sense of worth are taught (Gilbert, 2009). This treatment is designed by the research activities of Gilbert (2005). In the present study, this treatment method will be held in 12 sessions, each session for 90 minutes and in groups once a 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no need to publish data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Dehghan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, first floor, water apartments, Farmandari street, Farhangian alley.</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5351869012</zip>
        <telephone>+98 41 3322 4021</telephone>
        <email>hamidreza.dehghan313@ymz.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Habibolah Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Humanities and Social Sciences, University Blvd., Campus of Mazandaran University, Shahid Zolfaghari Blvd.</address>
        <city>babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741613534</zip>
        <telephone>35303565</telephone>
        <email>h.naderi@umz.ac.ir</email>
        <affiliation>University of Mazandaran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having high-risk behaviors based on a screening questionnaire
Willingness to participate in the study
No other mental disorders</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>17 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Participate in other intervention programs at the same time</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>یادگیری</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>F81.0</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Transcranial Direct-Current Stimulation (tDCS) is a technique used to modify and modify brain function, which is now used as a healthy and effective procedure to treat most neurological conditions and even in medicine. Electrical Stimulation Technique A neural modification method that transmits electric current to a specific point in the skull over a very specific period of time, including an anode electrode that stimulates the nervous system and a cathode electrode that inhibits the nervous system. To stimulate the centers of the prefrontal cortex, this is responsible for controlling the complex movements of the anode electrode on the prefrontal cortex and the cathode electrode on the opposite shoulder (according to the 10-20 EEG system). Participants sit in a comfortable chair in a quiet room with no other sensory stimuli. Electrical stimulation of the brain by tDCS (Canadian-made Mind-Alif brand device) was instilled in students in a steady stream with a constant current of between 1.5 and 2 mA (intensity appropriate for client tolerance). Every other day and for 10 days, using a pair of 5×5 cm rubber electrodes covered with artificial sponge soaked in a normal saline solution and placed in the desired areas.</i_keyword>
      <i_keyword>Control group: They did not receive any treatment.</i_keyword>
      <i_keyword>Intervention group: Cognitive therapy based on a compassionate mind: Compassionate mind training is one of the psychotherapy methods in which empathy, empathy, compassion, acceptance and tolerance, responsibility and a sense of worth are taught (Gilbert, 2009). This treatment is designed by the research activities of Gilbert (2005). In the present study, this treatment method will be held in 12 sessions, each session for 90 minutes and in groups once a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Behavioral brain systems. Timepoint: Before and after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Dark personality traits. Timepoint: Before and after the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>قبل و بعد از مداخله. Timepoint: Before and after the intervention. Method of measurement: questionnaire.</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 Mazandaran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-30</approval_date>
        <contact_name>Tabriz University of Medical Sciences</contact_name>
        <contact_address>Basmanj Street. Medical School - Second Floor Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
