<?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>IRCT20211223053494N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-27</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of integrated transdiagnostic therapy (UP) and acceptance and commitment therapy (ACT) on rumination, life satisfaction, treatment citizenship, emotional disorders, gastrointestinal symptoms and perceived stress in patients with irritable bowel syndrome (IBS)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of integrated transdiagnostic therapy(UP) and acceptance and commitment therapy(ACT) on rumination, life satisfaction, treatment citizenship, emotional disorders, gastrointestinal symptoms and perceived stress in patients with irritable bowel syndrome(IBS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64319</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In order to avoid the effect of restrictive variables, after randomly selecting the subjects and examining the criteria for entering the research, the samples of the two groups in terms of contextual variables (age, sex, education, marriage) try to be matched and thus They are included in the study and in each group, the treatment is performed as a single blind that patients are not aware of the treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irritable bowel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: includes patients with irritable bowel syndrome who receive integrated transdiagnostic treatment intervention in 10 sessions. The content of the first session includes increasing motivation to participate in treatment, motivational interview for patient participation and involvement, presenting the logic of treatment and setting treatment goals. Emotional experiences and AR model (history, responses, outcomes). The content of the third and fourth sessions includes teaching emotional awareness, learning to observe emotional experiences (emotions and reacting to emotions), especially using mindfulness techniques. The content of the fifth session includes re-evaluation and cognitive re-evaluation. Creating awareness of the impact and interrelationship between thoughts and emotions, identifying automatic maladaptive evaluations and cognitive re-evaluation and increasing flexibility in thinking. The content of the sixth and seventh sessions includes identifying patterns of emotion avoidance and examining emotion-induced behaviors. Familiarity and identification of emotion-induced behaviors and understanding their impact on emotional experiences, identifying maladaptive EDBS, and developing alternative action tendencies by coping with behaviors. The content of the eighth body includes awareness and tolerance of physical feelings. Increasing awareness of the role of physical feelings in emotional experiences, performing physiological visceral exposure or confrontation exercises in order to be aware of physical feelings and increase tolerance of these symptoms. The content of the ninth and tenth sessions includes visceral confrontation and confrontation with emotion based on situation, learning about the logic of emotional dreams, teaching how to prepare the hierarchy of fear and avoidance and designing repetitive and effective emotional confrontation exercises visually and objectively and inhibition. Avoid. Session 11 and 12: Prevention of recurrence. Overview of treatment concepts and discussion of the patient's recovery and therapeutic progress. Intervention 2: Intervention group 2: includes patients with irritable bowel syndrome who receive the intervention of acceptance and commitment treatment in 8 sessions.The content of the first session includes establishing a therapeutic relationship and an overall assessment.The content of the second session includes creative helplessness, exploring the world inside and out, and understanding that control is the problem, not the solution. The content of the third session includes identifying individual values, specifying values, practices, and barriers. The content of the fourth session includes examining one's values ​​and using relevant metaphors. The content of the fifth session includes examining fusion and faulting and performing exercises for faulting using metaphor.The content of the sixth session includes explaining the concepts, role and context, observing oneself as a context. The content of the seventh session includes emphasizing the present and presenting an instruction on the effective use of the present and the present.The content of the eighth session includes commitment training, reviewing life stories, identifying behavioral plans according to values, and summarizing.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirsam Kianimghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences - next to Taleghani Hospital - Yemen Street - Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>as.kianimghadam@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirsam Kianimghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences - next to Taleghani Hospital - Yemen Street - Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>as.kianimghadam@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a diagnosis of irritable bowel syndrome
Age over 18 years old
Conscious satisfaction with conducting research
Having at least a third grade of secondary education</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Three consecutive absences in treatment sessions
Reluctance to continue the treatment process
Incompleteness of one of the questionnaires, in which case the rest of the questionnaires related to that person will be deleted</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: includes patients with irritable bowel syndrome who receive integrated transdiagnostic treatment intervention in 10 sessions. The content of the first session includes increasing motivation to participate in treatment, motivational interview for patient participation and involvement, presenting the logic of treatment and setting treatment goals. Emotional experiences and AR model (history, responses, outcomes). The content of the third and fourth sessions includes teaching emotional awareness, learning to observe emotional experiences (emotions and reacting to emotions), especially using mindfulness techniques. The content of the fifth session includes re-evaluation and cognitive re-evaluation. Creating awareness of the impact and interrelationship between thoughts and emotions, identifying automatic maladaptive evaluations and cognitive re-evaluation and increasing flexibility in thinking. The content of the sixth and seventh sessions includes identifying patterns of emotion avoidance and examining emotion-induced behaviors. Familiarity and identification of emotion-induced behaviors and understanding their impact on emotional experiences, identifying maladaptive EDBS, and developing alternative action tendencies by coping with behaviors. The content of the eighth body includes awareness and tolerance of physical feelings. Increasing awareness of the role of physical feelings in emotional experiences, performing physiological visceral exposure or confrontation exercises in order to be aware of physical feelings and increase tolerance of these symptoms. The content of the ninth and tenth sessions includes visceral confrontation and confrontation with emotion based on situation, learning about the logic of emotional dreams, teaching how to prepare the hierarchy of fear and avoidance and designing repetitive and effective emotional confrontation exercises visually and objectively and inhibition. Avoid. Session 11 and 12: Prevention of recurrence. Overview of treatment concepts and discussion of the patient's recovery and therapeutic progress.</i_keyword>
      <i_keyword>Intervention group 2: includes patients with irritable bowel syndrome who receive the intervention of acceptance and commitment treatment in 8 sessions.The content of the first session includes establishing a therapeutic relationship and an overall assessment.The content of the second session includes creative helplessness, exploring the world inside and out, and understanding that control is the problem, not the solution. The content of the third session includes identifying individual values, specifying values, practices, and barriers. The content of the fourth session includes examining one's values ​​and using relevant metaphors. The content of the fifth session includes examining fusion and faulting and performing exercises for faulting using metaphor.The content of the sixth session includes explaining the concepts, role and context, observing oneself as a context. The content of the seventh session includes emphasizing the present and presenting an instruction on the effective use of the present and the present.The content of the eighth session includes commitment training, reviewing life stories, identifying behavioral plans according to values, and summarizing.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of Intensity of Gastrointestinal Symptoms in questionnaire (GSRS). Timepoint: At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention. Method of measurement: Questionnaire of Intensity of Gastrointestinal Symptoms (GSRS).</prim_outcome>
      <prim_outcome>Perceived Stress Score in Cohen Questionnaire. Timepoint: At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention. Method of measurement: Cohen Perceived Stress Questionnaire.</prim_outcome>
      <prim_outcome>Adherence of Medication Score in Morisky scale. Timepoint: At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention. Method of measurement: Morisky Medication Adherence Scale.</prim_outcome>
      <prim_outcome>Life Satisfaction Score in Diener Questionnaire. Timepoint: At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention. Method of measurement: Diener Life Satisfaction Questionnaire.</prim_outcome>
      <prim_outcome>Rumination-Reflection Score in Nolen-Hoeksema and Morrow Scale. Timepoint: At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention. Method of measurement: Rumination-Reflection Scale.</prim_outcome>
      <prim_outcome>Depression and Anxiety and Stress Score in Antony Scale DASS-21. Timepoint: At the beginning of the study (before the intervention), after the intervention and 3and 6 months after the intervention. Method of measurement: Depression and Anxiety and Stress Scale Antony (dass-21).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-12</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>School of Medicine, Shahid Beheshti University of Medical Sciences, next to the University Headquarters, Shahid Chamran Evin Highway, Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
