<?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>IRCT20200207046399N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of Cognitive Behavioral Therapy and Emotional Therapy in Patients with Irritable Bowel Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Comparing  the Effectiveness of Cognitive- Behavioral Therapy   and  Emotion- Focused  Therapy on Resiliency, Tolerance of Distress and Quality of Life in Patients with Irritable Bowel Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46748</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Subjects will be selected by purposeful sampling. In the first consultation session after structured clinical interview with patients and considering inclusion and exclusion criteria, eligible patients will be asked to complete Connor-Davidson Resilience Scale, Simmons&amp; Ganer  Distress Scale. The quality of life of patients with irritable bowel syndrome respond. After the initial evaluation of the patients, the patients who received the lowest mean in these questionnaires, 45 patients were selected and randomly divided into three groups of 15 experimental subjects, the first group cognitive behavioral therapy, the second group emotional therapy and control group. They will be divided. Then the first and second groups will be given eight sessions of 90 minutes once a week, and the control group will receive no intervention. After the intervention sessions, the questionnaires will be given to the patients as post-test and 3 months later for follow up in all 3 groups and the results of the groups will be compared again.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irritable Bowel Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Cognitive behavioral therapy intervention group. The treatment model used in Cognitive-Behavioral Therapy was based on a general pattern of available resources, considering the nature and nature of irritable bowel syndrome in Iranian patients, and applied behavioral and educational methods. Treatment sessions consist of 8 sessions of once a week for one hour and a half with the purpose of identifying unpleasant thoughts and cognitive errors, reducing stress, increasing resiliency, increasing distress tolerance, improving patients' quality of life and ultimately preventing relapse. It was a disease. Overall Session 1 includes focusing on evaluating, identifying and articulating the goals of Cognitive Behavioral Therapy, and Sessions 2 to 8 including feedback from the previous session, assignment review, discussion of assignment, goal setting, key issues presentation, information on IBS related problems, Identifying and introducing behaviors that affect the severity of IBS symptoms and related cognitive strategies, training stress management techniques and skills were required. At the end of each session, patients were given a summary of the same session and homework assignments. Intervention 2: Emotion-focused intervention group: first session Introducing clients, communicating and communicating the general principles of an emotion-focused approach. Second session: Creating therapeutic alliance, discovering highlights of the third session: Examining past traumas and identifying attachment type, naming emotionally, identifying emotions Fourth Session: Running an Empty Chair Fifth Session: Relaxation Technique Sixth Session: Reopening Symbols and Emotional Problems Seventh Session: Describing and Talking about Mood, Inconvenience, Anger, Tests, and Ecclesiastes Post-test sessions after three months in the paging phase Ray will repeat the tests. Intervention 3: Control group: no intervention in this group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Once the thesis is completed, the decision will be made if the expected outcome is achieved</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mitra Jahangirrad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 33, East Twentieth Alley, North Kargar Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1437647790</zip>
        <telephone>+98 21 8822 3620</telephone>
        <email>m.jahangirrad@iaukishint.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Adis Keraskian Mojmenari, Ph.D.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO. 79, Unit 28 St., Shahid Dastgerdi St., Shariati St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1911817639</zip>
        <telephone>+98 21 2226 7303</telephone>
        <email>Adis.Kraskian@Kiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having diagnostic criteria for irritable bowel syndrome with the approval of a gastroenterologist
No use of psychological drugs and psychological therapies within three months
Willingness to participate in the scheme
High school diploma
Being over 20 years old
No addiction to any drug
Commitment to attend therapy sessions
Low Resiliency Questionnaire and Quality of Life Questionnaire for Patients with Irritable Bowel Syndrome</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of colon cancer in the family
Having a psychiatric illness and taking psychiatric drugs
Having Colon Organ Disease
Unwillingness to participate in research project</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K58</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Irritable bowel syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Cognitive behavioral therapy intervention group. The treatment model used in Cognitive-Behavioral Therapy was based on a general pattern of available resources, considering the nature and nature of irritable bowel syndrome in Iranian patients, and applied behavioral and educational methods. Treatment sessions consist of 8 sessions of once a week for one hour and a half with the purpose of identifying unpleasant thoughts and cognitive errors, reducing stress, increasing resiliency, increasing distress tolerance, improving patients' quality of life and ultimately preventing relapse. It was a disease. Overall Session 1 includes focusing on evaluating, identifying and articulating the goals of Cognitive Behavioral Therapy, and Sessions 2 to 8 including feedback from the previous session, assignment review, discussion of assignment, goal setting, key issues presentation, information on IBS related problems, Identifying and introducing behaviors that affect the severity of IBS symptoms and related cognitive strategies, training stress management techniques and skills were required. At the end of each session, patients were given a summary of the same session and homework assignments.</i_keyword>
      <i_keyword>Emotion-focused intervention group: first session Introducing clients, communicating and communicating the general principles of an emotion-focused approach. Second session: Creating therapeutic alliance, discovering highlights of the third session: Examining past traumas and identifying attachment type, naming emotionally, identifying emotions Fourth Session: Running an Empty Chair Fifth Session: Relaxation Technique Sixth Session: Reopening Symbols and Emotional Problems Seventh Session: Describing and Talking about Mood, Inconvenience, Anger, Tests, and Ecclesiastes Post-test sessions after three months in the paging phase Ray will repeat the tests</i_keyword>
      <i_keyword>Control group: no intervention in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: Before the intervention, after the intervention and 3 months follow up. Method of measurement: Conner &amp; Davidson Resilience Scale.</prim_outcome>
      <prim_outcome>Tolerance of distress. Timepoint: Before the intervention, after the intervention and 3 months follow up. Method of measurement: Simmons&amp; Gaher Distress Tolerance Scale.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the intervention, after the intervention and 3 months follow up. Method of measurement: Quality of Life Scale in Patients with Irritable Bowel Syndrome.</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>2019-12-07</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Shahid Chamran Blvd., Hormozgan University of Medical Sciences Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
