<?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>IRCT20210128050165N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-26</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Transdiagnostic Intervention and Mindfulness Based Schema Therapy on Patients with Breast Cancer</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Transdiagnostic Intervention and Mindfulness Based Schema Therapy on Cancer Psychological Distress and Outcomes, Illness's Transdiagnostic Cognitive Processes and Cortisol Level in Patients with Breast Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56065</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first stage based on entrance criteria, the intended sample will be identified from Mashhad hospitals and in the second stage, 60 patients from them will be choose randomly from the number codes assigned to them.  number codes will be assigned to each person and randomly will be taken out from drawing without replacement and the sequence will be noted for each participant. In the second stage, number codes will be assigned to one of the three groups and randomly will be taken out from drawing without replacement and control or intervention groups will be drawn. In the third stage, each person will be assigned to each group randomly and this process will continue to the last person. It's necessary to be noted that dividing to the 3 groups will be done separately for each person and at last it will also be determined randomly that each one of the groups will receive which intervention or will be control group. One of the groups of intervention or control with using random numbers table sampling and assigning number code to each person (2 intervention groups and 1 control group). simple randomization way will be done (divide to 3 groups in sequence and concealment and assiging interventions with random concealment allocation), Blinding description: participants in groups won't be informed about the other groups and the type and difference of other interventions with their own and they won't have communication with each other out of sessions. Execution of the questionnaires will be performed in pretest, post test and follow up by research's assistants who won't be informed about the type of groups and difference between interventions participants will receive or have received. data analysis will be done by someone else who won't know about the types of groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 2 groups, one will receive Transdiagnostic therapy and the other will receive Mindfulness based Schema therapy via internet. the period of each group therapy will be 10 session in group therapy format and 90 minutes. standard therapy sessions' protocols for mindfulness based schema therapy are from book with the same name (Vreeswijk, Broersen, J. Schurink, 2014) and Unified transdiagnostic therapy for emotional disorders (Barlow and others, 2016) and related scientific articles. the goal of Transdiagnostic therapy is for emotion processing and emotional experiences regulation and mindfulness based schema therapy is to becoming aware of schemas and mentalities, other attention domains such as monitoring emotions, body sensations and schema related coping mechanisms. Intervention 2: Control group: 1 group that is list waiting and later will receive 2 education sessions about life style behaviors.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographic information and variables' measuring data will be shared in thesis and science journals' articles.

When:
start from six months after collecting data

To whom:
researchers from universities and science journals

Conditions:
using data is acceptable in other science interventions for refrences

Where to obtain:
science journals articles, Azad University of Birjand

How to obtain:
sending emails to authors of article and thesis or sending request to Azad University of Birjand

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Ghayour Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alandasht intersection, Koohsangi Ave, Omid hospital</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9197835399</zip>
        <telephone>+98 51 3606 1093</telephone>
        <email>fgkazemi@yahoo.com</email>
        <affiliation>Azad University of Birjand,  Mashhad Medicine University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Ghayour Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alandasht intersection, Koohsangi Ave, Omid hospital</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9197835399</zip>
        <telephone>+98 51 3606 1093</telephone>
        <email>fgkazemi@yahoo.com</email>
        <affiliation>Azad University of Birjand, Mashhad Medicine University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>not using psychiatric drugs
age between 30 to 60
education at least end of elementary school
going under cancer therapy (except chemotherapy)</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>using psychiatric drugs or psychotherapies in the last 6 months
absence in group therapy more than 2 sessions
graduate from psychology major or related to that
experienced trauma pressures or crisis in the grouptherapy for instance mourn</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 2 groups, one will receive Transdiagnostic therapy and the other will receive Mindfulness based Schema therapy via internet. the period of each group therapy will be 10 session in group therapy format and 90 minutes. standard therapy sessions' protocols for mindfulness based schema therapy are from book with the same name (Vreeswijk, Broersen, J. Schurink, 2014) and Unified transdiagnostic therapy for emotional disorders (Barlow and others, 2016) and related scientific articles. the goal of Transdiagnostic therapy is for emotion processing and emotional experiences regulation and mindfulness based schema therapy is to becoming aware of schemas and mentalities, other attention domains such as monitoring emotions, body sensations and schema related coping mechanisms.</i_keyword>
      <i_keyword>Control group: 1 group that is list waiting and later will receive 2 education sessions about life style behaviors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cancer Psychological Outcomes. Timepoint: pretest, post test, follow up. Method of measurement: Impact Of Breast Cancer questionnaire, Cancer Survivors Resilience Scale, Breast Cancer Self-Efficacy Scale.</prim_outcome>
      <prim_outcome>Psychological Distress. Timepoint: pretest, post test, follow up. Method of measurement: Psychological Impact of Cancer, Spiritual Distress Scale, Depression, Anxiety and Stress Scale-21.</prim_outcome>
      <prim_outcome>Illness's Transdiagnostic Cognitive Processes. Timepoint: pretest, post test, follow up. Method of measurement: Acceptance and Action Questionnaire, Posttrumatic Avoidance Scale, Chronic illness-related cognitive fusion questionnaire, Rumination in response to illness scale.</prim_outcome>
      <prim_outcome>Cortisol. Timepoint: pretest, post test. Method of measurement: blood sampling.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Islamic Azad University of Birjand</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_name>Islamic Azad University of Birjand</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-24</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
