<?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>IRCT20221108056439N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-21</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of psychological treatments on patients with gastric ulcers</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effectiveness of mindfulness-based cognitive therapy with emotion-oriented group therapy on experiential avoidance, cognitive emotion regulation and anxiety sensitivity in patients with gastric ulcer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67433</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Permuted Block Randomization method with a block size of 6 was used to randomly assign people to three equal groups. A block randomization design was generated using the free website Randomization.com (http://randomization.com). Randomization is individual and the central concealment method is used. People are registered in a central list in the order of their entry into the study and get a code. During the study, contact is made with the person outside the team and each person is assigned to the desired group, Blinding description: Data will be collected by someone who is not aware of the research objectives. The collected data will be entered into the software and analyzed by a person who is not aware of the research objectives.</study_design>
      <phase>N/A</phase>
      <hc_freetext>gastric ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mindfulness based on cognitive therapy: The intervention will take place for eight weeks and the sessions will be held weekly. Each session lasts 90 minutes. The content of the sessions was designed based on the study of Tizdell and Segal (2000). Intervention 2: Intervention group: emotion oriented: this intervention is designed for ten sessions. The design of the meetings was based on the studies of Greenberg (2016) and Johnson (2005). The sessions will be twice a week and each session will be 90 minutes. Intervention 3: Control group: will receive only routine medical treatments during the intervention period.</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:
In this study, none of the patients' personal information will be shared. And only data related to the main outcome of the intervention is shared.

When:
The access period starts 6 months after the results are published

To whom:
Researchers in academic institution psychologist, physicians

Conditions:
Applicants are only allowed to use the information that is available to them only in clinical work and should not publish this information.

Where to obtain:
amanloo.fatemeh5@gmail.com
Fatemeh Amanlu

How to obtain:
Applicants' emails will be answered within a maximum of one week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Amanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.20,Golestan,91/1 Hashemiye Blvd,Vakilabad Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178194346</zip>
        <telephone>+98 51 3870 3119</telephone>
        <email>Amanloo.fatemeh5@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Amanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.20,Golestan,91/1 Hashemiye Blvd,Vakilabad Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178194346</zip>
        <telephone>+98 51 3870 3119</telephone>
        <email>Amanloo.fatemeh5@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age 18-50
no mental condition
Not suffering from chronic physical illness other than gastric ulcer
education diploma and higher</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>drug abuse
no willing to participation in study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gastric ulcer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mindfulness based on cognitive therapy: The intervention will take place for eight weeks and the sessions will be held weekly. Each session lasts 90 minutes. The content of the sessions was designed based on the study of Tizdell and Segal (2000).</i_keyword>
      <i_keyword>Intervention group: emotion oriented: this intervention is designed for ten sessions. The design of the meetings was based on the studies of Greenberg (2016) and Johnson (2005). The sessions will be twice a week and each session will be 90 minutes.</i_keyword>
      <i_keyword>Control group: will receive only routine medical treatments during the intervention period</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive emotion regulation. Timepoint: before intervention and after the intervention and one month after  intervention. Method of measurement: emotional regulation questionnaire of Garnevsky and Kraij.</prim_outcome>
      <prim_outcome>Anxiety sensitivity. Timepoint: before intervention and after the intervention and one month after  intervention. Method of measurement: anxiety sensitivity questionnaire of Taylor and Cox.</prim_outcome>
      <prim_outcome>Experimental avoidance. Timepoint: before intervention and after the intervention and one month after  intervention. Method of measurement: Experiential Avoidance Questionnaire Bund et al(2007).</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>2022-09-10</approval_date>
        <contact_name>ethic committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Paris colony, Azadi Sq, Mashahd mashahd Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
