<?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>IRCT2017011932057N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-19</date_registration>
      <primary_sponsor>Vice chancellor for research of Kashan University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>Effectiveness Of Acceptance and Commitment Therapy on male  smokers</public_title>
      <acronym></acronym>
      <scientific_title>Controlled trial of effectiveness of Acceptance and Commitment Therapy on  depression, anxiety, risky decision making, craving and cessation in male smokers.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25070</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The population consisted of all male smokers admitted to center treatment of drug abuse and smoking in Kargrnzhad psychiatric hospital.&#13;
from all participation's that meets inclusion criteria,35 participants for each group selected by  Random assignment will be done,that  by the use of computer-generated random numbers.&#13;
 intervention duration is six weeks.  one week after intervention, post-test data is collecting. six weeks later follow-up data was measured.pre-test data is done by the investigator prior to the intervention.intervention duration is six weeks.  one week after intervention, post-test data is collecting. six weeks later follow-up data was measured.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: nicotine dependence. Condition 2: depression. Condition 3: anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This study is conducted to determine the effectiveness of Acceptance and Commitment Therapy (ACT) on depression, anxiety, risky decision making, craving and cessation in male smokers . The aim of this approach is invites people to open up to unpleasant feelings, and learn not to overreact to them, and not avoiding situations where they are invoked. Its therapeutic effect is a positive spiral where feeling better leads to a better understanding of the truth and also experienced flexible life.  this treatment is  during the eight 90-minute sessions for two months. Intervention 2: Control Group: This group will receive behavioral interventions for smoking cessation that approved by the Ministry of Health of Iran that is used for the smoking cessation centers and based on the psych-education and motivational interview.this protocol like intervention group during the eight 90-minute sessions for two months.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Davoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5554 9111</telephone>
        <email>davoudi-mr@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad reza Davoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5554 9111</telephone>
        <email>davoudi-mr@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:1.Having an age of 18–40 years, 2.Having a degree in secondary education or higher, 3.nicotine dependence based on DSM 5 diagnostic criteria&#13;
exclusion criteria:1.Having a known-cause depression or anxiety following problems such as loss, marital conflicts and divorce, 2.Having a history of psychotic disorders, 3.Receiving psychotherapy or drug therapy during past six months, 4.Unwillingness to continue participating in the study , 5.Failing to participate in more than two sessions of the study intervention 6.Had a history of substance abuse disorders;</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F17</hc_code>
      <hc_code>F32.0</hc_code>
      <hc_code>F49.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders due to use of tobacco</hc_keyword>
      <hc_keyword>Two or three of the above symptoms are usually present. The patient is usually distressed by these but will probably be able to continue with most activities.</hc_keyword>
      <hc_keyword>Anxiety NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This study is conducted to determine the effectiveness of Acceptance and Commitment Therapy (ACT) on depression, anxiety, risky decision making, craving and cessation in male smokers . The aim of this approach is invites people to open up to unpleasant feelings, and learn not to overreact to them, and not avoiding situations where they are invoked. Its therapeutic effect is a positive spiral where feeling better leads to a better understanding of the truth and also experienced flexible life.  this treatment is  during the eight 90-minute sessions for two months.</i_keyword>
      <i_keyword>Control Group: This group will receive behavioral interventions for smoking cessation that approved by the Ministry of Health of Iran that is used for the smoking cessation centers and based on the psych-education and motivational interview.this protocol like intervention group during the eight 90-minute sessions for two months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before intervention, After intervention, One month after intervention. Method of measurement: Beck depression inventory.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention, After intervention, One month after intervention. Method of measurement: Beck Anxiety Inventory.</prim_outcome>
      <prim_outcome>Craving(nicotine dependence). Timepoint: Before intervention, After intervention, One month after intervention. Method of measurement: fagestrom Craving scale.</prim_outcome>
      <prim_outcome>Risky decision making. Timepoint: Before intervention, After intervention, One month after intervention. Method of measurement: Iowa gambling test.</prim_outcome>
      <prim_outcome>Smoking cessation. Timepoint: Before intervention, After intervention, One month after intervention. Method of measurement: Expiratory CO2 concentration.</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>Vice chancellor for research of Kashan University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-12-08</approval_date>
        <contact_name>Ethics committee of kashan University of Medical Sciences</contact_name>
        <contact_address>Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
