<?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>IRCT20101130005280N51</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of direct electrical electrical stimulation (TDCS)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of direct electrical stimulation of the brain (TDCS) and cognitive-behavioral therapy (CBT) in reducing cravings, mood and smoking dependence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62143</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Randomization is done in a simple way using a random number table using the site www.randomization.com. The numbers will be placed in sealed envelopes and when the participants enter, each envelope will be assigned to one of the two groups. The people in even pairs are the control group and the people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>direct electrical stimulation of the brain (TDCS) and cognitive-behavioral therapy (CBT) in reducing cravings, mood and smoking dependence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 6 patients in TDCS treatment of direct current cranial wall stimulation (tDCS): each session according to the treatment protocol is for 10 sessions of 20 to 30 minutes and after connecting the cathode and Andy to the test head of the lateral dorsal region We stimulate the prefrontal lobe. Device name: TDS current intensity 2 mAh. All subjects will respond to the Fagstrom Nicotine Dependence Test (FTND), the Positive and Negative Emotion Scale (PNAS), and the Smoking Attitude Questionnaire (UTS) before and after treatment. Intervention 2: Control group: 6 people in Cognitive-Behavioral Therapy (CBT): Each session will receive 1 to 1.5 hours of cognitive-behavioral therapy for 9 sessions according to the treatment process, so that the subject of session 1 is to create and maintain motivation for change. Session 2: Identifying and coping with motivating situations, Session 3: Tackling temptation, Session 4: Refusal skills, social situation management and courage ..., Session 5: Making wise decisions when choosing, Session 6: Problem solving, Session 7 is lifestyle modification and coping with boredom, the topic of Session 8 is the management of boredom and boredom and the topic of Session 9 is prevention of recurrence, maintaining stability and termination of treatment. PNAS and Smoking Questionnaire (UTS) will answer before and after treatment.</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>Hossein Share</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ferdowsi University of Mashhad, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3879 6773</telephone>
        <email>hoshareh@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Share</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ferdowsi University of Mashhad, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3879 6773</telephone>
        <email>hoshareh@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People addicted to cigarettes
male gender</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>History of mental illness and use of psychiatric drugs</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 6 patients in TDCS treatment of direct current cranial wall stimulation (tDCS): each session according to the treatment protocol is for 10 sessions of 20 to 30 minutes and after connecting the cathode and Andy to the test head of the lateral dorsal region We stimulate the prefrontal lobe. Device name: TDS current intensity 2 mAh. All subjects will respond to the Fagstrom Nicotine Dependence Test (FTND), the Positive and Negative Emotion Scale (PNAS), and the Smoking Attitude Questionnaire (UTS) before and after treatment.</i_keyword>
      <i_keyword>Control group: 6 people in Cognitive-Behavioral Therapy (CBT): Each session will receive 1 to 1.5 hours of cognitive-behavioral therapy for 9 sessions according to the treatment process, so that the subject of session 1 is to create and maintain motivation for change. Session 2: Identifying and coping with motivating situations, Session 3: Tackling temptation, Session 4: Refusal skills, social situation management and courage ..., Session 5: Making wise decisions when choosing, Session 6: Problem solving, Session 7 is lifestyle modification and coping with boredom, the topic of Session 8 is the management of boredom and boredom and the topic of Session 9 is prevention of recurrence, maintaining stability and termination of treatment. PNAS and Smoking Questionnaire (UTS) will answer before and after treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tendency to smoke. Timepoint: Before and after the treatment program. Method of measurement: Fagstrom Nicotine Dependence Test (FTND), Positive and Negative Emotion Scale (PNAS) and Smoking Tendency Questionnaire (UTS).</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>2022-01-30</approval_date>
        <contact_name>Ethics Committee of Ferdowsi University of Mashhad</contact_name>
        <contact_address>Ferdowsi University of Mashhad, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
