<?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>IRCT2016022826807N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-05</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran university of medical Sciences</primary_sponsor>
      <public_title>The effectiveness of emotional schema therapy on the modification of emotional schemas and difficulties of emotional regulation with irritable bowel syndrome</public_title>
      <acronym>EST</acronym>
      <scientific_title>The effectiveness of emotional schema therapy on the modification of emotional schemas and difficulties of emotional regulation in women with irritable bowel syndrome: single-subject design</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22113</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: The method of research is of single-subject design type. It was used A-B schema with stepwise method. Generally, the first position (A) is the basic line, in second position (B) is performed a therapeutic intervention and then, dependent variable is evaluated. In the study, independent variable is emotional schema therapy and dependent variables are therapeutic variations due use of the treatment method on the modification of emotional schemas and emotion regulation difficulty.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Irritable bowel syndrome. Condition 2: Irritable bowel syndrome.</hc_freetext>
      <i_freetext>. It has been presented a summary of content of sessions of emotional schema therapy in Table 1. &#13;
&#13;
        Table 1: a summary of content of sessions of emotional schema therapy&#13;
Sessions	Content of sessions&#13;
First session	Formation of therapeutic relation, planning of case formulation, presentation of treatment logic and treatment aims, presentation of etiologic model and treatment from emotional schema therapy approach&#13;
Second session	Normal and problematic emotions, consideration of painful emotions of patients and normalization of them, emotion self-awareness, instruction and introduction of emotion, identification and labeling of emotion, differentiation between different emotions, identification of emotion in physical and psychological state &#13;
Third session	Self-evaluation with the aim to recognize own emotion experiences, self-evaluation with the aim to identification of the amount of individuals emotion vulnerability, self-evaluation with the aim to identification of the strategies for emotion regulation, cognitive issues of emotion responses, physiologic issues of emotion responses, behavior outcomes of emotion responses and relation among them, introduction of rage emotion and the ways for dominance on rage &#13;
Forth session	Proceeding identified emotional schemas in patient, verbal challenges and Socratic dialogue&#13;
Fifth session	Proceeding other identified emotional schemas in patient and verbal challenges and Socratic dialogue, instruction of the technique of writing of negative memorabilia  with the aim to facility of emotion processing&#13;
Sixth session	prevention of social seclusion  and avoidance, instruction of strategy of problem solving, training of interpersonal skills (talking, self-expression and conflict resolution), preliminary introduction of the conception of acceptance and emotion validation &#13;
Seventh session	Helping people for acceptance of own emotion, proceeding intervening emotional schemas in acceptance and experience of painful emotion, presentation of detached mindfulness technique &#13;
Eighth session	Introduction of kinds of negative beliefs about emotions and challenge to them, identification of false evaluation and their effects on the emotion states&#13;
Ninth session	Identification of the amount and the way of using of inhibition strategy and investigation of its emotion outcomes, instruction of emotion expression, encounter, training of  abreaction, relaxation&#13;
Tenth session	Discussion about severity of schemas before and after of confrontation, proceeding reminder avoidance of patient &#13;
Eleventh session	Review of sessions and practice of learned skills&#13;
Twelfth session	Work on therapy program (prevention of  recurrence), schematization for support sessions, homework, commitment to continuous usage of treatment practices&#13;
&#13;
  	&#13;
According to the observed therapeutic sessions’ content, therapist used a skill for patients and clarified it with examples of themselves..</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>Arefeh Erfan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran university of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5350 1423</telephone>
        <email>a_erfan@razi.tums.ac.ir</email>
        <affiliation>Tehran university of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arefeh Erfan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran university Of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5350 1423</telephone>
        <email>a_erfan@razi.tums.ac.ir</email>
        <affiliation>Tehran university Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria  (having ROME III diagnostic criteria confirmed by digestion specialist for differentiation IBS from other functional gastrointestinal disorders, no consumption of psychiatry drugs during three months ago, no participation in psychology interventions session during six months ago, having  high school education or higher, dominance on Persian language, have satisfaction for participation) and Exclusion criteria   (having symptoms such as gastrointestinal blooding, existence of blood in excretion, fever, losing weight, anemia during six months ago, nnocturnal diarrhea, bellyache that  awakes patients from sleep, palpable mass  in physical examination , older than 50 and younger than 20, having a family history of colon cancer, having sever psychiatry disease)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k58.0</hc_code>
      <hc_code>k58.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irritable bowel syndrome with diarrhoea</hc_keyword>
      <hc_keyword>Irritable bowel syndrome with diarrhoea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>. It has been presented a summary of content of sessions of emotional schema therapy in Table 1. &#13;
&#13;
        Table 1: a summary of content of sessions of emotional schema therapy&#13;
Sessions	Content of sessions&#13;
First session	Formation of therapeutic relation, planning of case formulation, presentation of treatment logic and treatment aims, presentation of etiologic model and treatment from emotional schema therapy approach&#13;
Second session	Normal and problematic emotions, consideration of painful emotions of patients and normalization of them, emotion self-awareness, instruction and introduction of emotion, identification and labeling of emotion, differentiation between different emotions, identification of emotion in physical and psychological state &#13;
Third session	Self-evaluation with the aim to recognize own emotion experiences, self-evaluation with the aim to identification of the amount of individuals emotion vulnerability, self-evaluation with the aim to identification of the strategies for emotion regulation, cognitive issues of emotion responses, physiologic issues of emotion responses, behavior outcomes of emotion responses and relation among them, introduction of rage emotion and the ways for dominance on rage &#13;
Forth session	Proceeding identified emotional schemas in patient, verbal challenges and Socratic dialogue&#13;
Fifth session	Proceeding other identified emotional schemas in patient and verbal challenges and Socratic dialogue, instruction of the technique of writing of negative memorabilia  with the aim to facility of emotion processing&#13;
Sixth session	prevention of social seclusion  and avoidance, instruction of strategy of problem solving, training of interpersonal skills (talking, self-expression and conflict resolution), preliminary introduction of the conception of acceptance and emotion validation &#13;
Seventh session	Helping people for acceptance of own emotion, proceeding intervening emotional schemas in acceptance and experience of painful emotion, presentation of detached mindfulness technique &#13;
Eighth session	Introduction of kinds of negative beliefs about emotions and challenge to them, identification of false evaluation and their effects on the emotion states&#13;
Ninth session	Identification of the amount and the way of using of inhibition strategy and investigation of its emotion outcomes, instruction of emotion expression, encounter, training of  abreaction, relaxation&#13;
Tenth session	Discussion about severity of schemas before and after of confrontation, proceeding reminder avoidance of patient &#13;
Eleventh session	Review of sessions and practice of learned skills&#13;
Twelfth session	Work on therapy program (prevention of  recurrence), schematization for support sessions, homework, commitment to continuous usage of treatment practices&#13;
&#13;
  	&#13;
According to the observed therapeutic sessions’ content, therapist used a skill for patients and clarified it with examples of themselves.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional schemas. Timepoint: baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months. Method of measurement: baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months.</prim_outcome>
      <prim_outcome>Emotion regulation difficulty. Timepoint: baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months. Method of measurement: Emotion regulation difficulty questionnaire (DERS).</prim_outcome>
      <prim_outcome>Psychological symptom. Timepoint: baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months. Method of measurement: DASS.</prim_outcome>
      <prim_outcome>Severity and frequency of physical symptoms. Timepoint: baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months. Method of measurement: BSS-FS.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: baseline stage tests in baseline as well as third, sixth, ninth and twelfth sessions. Also, at last session each patient was asked to refer once a month for three months. Method of measurement: quality of life quation for IBS.</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, Tehran university of medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-24</approval_date>
        <contact_name>University Ethics Committee</contact_name>
        <contact_address>enghelab tehran university of medical sciences tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
