<?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>IRCT20181118041690N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-11</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison schema therapy and ACT</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of group schema therapy and ACT on personality disorders, cognitive emotion regulation and craving for drugs among addicted of addiction treatment campus in Gonbad Kavoos city</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>39</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35328</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization: Simple randomized assignment to groups did by random digit table. For this, MCMI-III accomplished for all addicted in campus of Gonbad Kavoos and selected 30 people who their scores were higher than cut point in personality disorders cluster B, as sample. Next to selection the sample individuals, provided a list of individuals and found their digits from random digit table  and randomly assigned to three groups. then, groups randomly by lottery assigned to schema therapy, acceptance and commitment therapy and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Addiction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acceptance and commitment therapy. Acceptance &amp; Commitment Therapy (ACT) created by Hayes (1986). This approach is a part of third wave of behavior therapy that based on Relational Frame Theory. Aim of this therapy is decreasing experiential avoidance with increasing psychological flexibility. Acceptance &amp; Commitment Therapy have six central processes that lead to psychological flexibility include: Defusion, Acceptance, Contact with the Present Moment, Observing Self, Values and Committed Action. This treatment was 12 sessions 90 minutes. In this intervention were not use any equipment and substances. Intervention 2: Intervention group: Schema therapy. Schema Therapy is a new and creative psychotherapy create by young et al. (1990) and integrate Cognitive-Behavior Therapy, attachment, Gestalt, Object Relations, Constructivism and Psychoanalysis. This treatment according to systematic program by use cognitive, behavioral, interpersonal, attachment and experiential appraise and modify Early Maladaptive Schemas. Schema therapy emphasize on developmental base of psychological distress in childhood and adolescence, arousal technics and maladjusted coping styles.This treatment was 12 sessions 90 minutes.  In this intervention were not use any equipment and substances.</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 Subject dissatisfaction</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahmood Piri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Kalantari BLVD</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4914739975</zip>
        <telephone>+98 17 3215 3000</telephone>
        <email>minapiri56@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Hosseinaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid  Rajaei street</address>
        <city>Azadshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4961789985</zip>
        <telephone>+98 17 3572 2222</telephone>
        <email>a.hosseinaei@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Campus habitation
Informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F10-F19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioral disorders due to psychoactive substance use</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: Acceptance and commitment therapy. Acceptance &amp; Commitment Therapy (ACT) created by Hayes (1986). This approach is a part of third wave of behavior therapy that based on Relational Frame Theory. Aim of this therapy is decreasing experiential avoidance with increasing psychological flexibility. Acceptance &amp; Commitment Therapy have six central processes that lead to psychological flexibility include: Defusion, Acceptance, Contact with the Present Moment, Observing Self, Values and Committed Action. This treatment was 12 sessions 90 minutes. In this intervention were not use any equipment and substances.</i_keyword>
      <i_keyword>Intervention group: Schema therapy. Schema Therapy is a new and creative psychotherapy create by young et al. (1990) and integrate Cognitive-Behavior Therapy, attachment, Gestalt, Object Relations, Constructivism and Psychoanalysis. This treatment according to systematic program by use cognitive, behavioral, interpersonal, attachment and experiential appraise and modify Early Maladaptive Schemas. Schema therapy emphasize on developmental base of psychological distress in childhood and adolescence, arousal technics and maladjusted coping styles.This treatment was 12 sessions 90 minutes.  In this intervention were not use any equipment and substances.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Personality disorder cluster B. Timepoint: Pretest, Post test, Fallow up. Method of measurement: MCMI-III.</prim_outcome>
      <prim_outcome>Cognitive emotion regulation. Timepoint: Pretest, Post test, Fallow up. Method of measurement: Garnefski Cognitive Emotion Regulation (2001).</prim_outcome>
      <prim_outcome>Craving. Timepoint: Pretest, Post test, Fallow up. Method of measurement: Tiffany et al. (1995) Heroin Craving Questionaire.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-15</approval_date>
        <contact_name>Academic ethic committee on biomedical research of Golestan university of medical sciences</contact_name>
        <contact_address>Shast kola road Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
