<?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>IRCT201606288473N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-05</date_registration>
      <primary_sponsor>Vice-chancellor for Research, Bushehr University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Metacognitive therapy on depression in women with breast cancer</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Meta-cognitive therapy model on depression, cognitive emotion regulation and meta-cognitive beliefs in depressed patients with breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8946</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Does  not have.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression.</hc_freetext>
      <i_freetext>Intervention 1: In the case group, meta-cognitive group therapy method will be held for 8 sessions per week. Metacognitions placed in cognitive-behavioral third wave of the treatment field that instead of amending the content of cognition, the cognitive processing and correction mechanisms involved. In this approach, it is believed that in mental disorders, cognitive Self-Regulatory Executive Function (S-REF) is placed in a defective processing cycle, which is known as the cognitive attentional syndrome (CAS). This syndrome which is the result of positive and negative metacognitive beliefs, causes a diversion in attention, cognitive processing techniques, cognitive-emotional orientation, and thus, is the continuation of the disorder. The goal of the treatment is modification and decreasing cognitive attentional syndrome, with the help of the techniques of mindfulness, distraction, correction of negative and positive beliefs and pain and emotional suffering population. Intervention 2: There won't be any interfering for the control group and they will be treated routinely.</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>Eelham Zahedian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr University of Medical Sciences, Bushehr, Iran</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>elhamzahed8766@gmail.com</email>
        <affiliation>Bushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoud Bahreini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bushehr University of Medical Sciences, Salman Farsi Street, Sabz Abad, Bushehr, Iran</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7518759577</zip>
        <telephone>+98 77 3345 0187</telephone>
        <email>msdbahreini@yahoo.com</email>
        <affiliation>Bushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age 20-55 years; with Breast Cancer; ranging from mild to moderate depression score; the desire to participate in the study; lack of clear psychotic mental disorder; Exclusion criteria: lack of desire to continue to participate in the study; Failure to participate in more than two sessions</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Depressive episode</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the case group, meta-cognitive group therapy method will be held for 8 sessions per week. Metacognitions placed in cognitive-behavioral third wave of the treatment field that instead of amending the content of cognition, the cognitive processing and correction mechanisms involved. In this approach, it is believed that in mental disorders, cognitive Self-Regulatory Executive Function (S-REF) is placed in a defective processing cycle, which is known as the cognitive attentional syndrome (CAS). This syndrome which is the result of positive and negative metacognitive beliefs, causes a diversion in attention, cognitive processing techniques, cognitive-emotional orientation, and thus, is the continuation of the disorder. The goal of the treatment is modification and decreasing cognitive attentional syndrome, with the help of the techniques of mindfulness, distraction, correction of negative and positive beliefs and pain and emotional suffering population.</i_keyword>
      <i_keyword>There won't be any interfering for the control group and they will be treated routinely.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention; after the intervention; one months after the intervention. Method of measurement: Beck Depression Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive Emotion Regulation; Metacognitive Beliefs. Timepoint: Before the intervention; After the intervention; A month after intervention. Method of measurement: Cognitive Emotional Regulation Questioner; Meta Cognitive Questioner-30.</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, Bushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-20</approval_date>
        <contact_name>Bushehr University of Medical Sciences</contact_name>
        <contact_address>Salman Farsi street, Sabz Abad, Bushehr Bushehr  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
