<?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>IRCT20250630066306N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-15</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The Efficacy of Acceptance and Commitment Therapy in the Treatment of Irritable Bowel Syndrome</public_title>
      <acronym>irritable bowel syndrome</acronym>
      <scientific_title>Investigating the Effectiveness of  Acceptance and Commitment Therapy on Lifestyle, Psychological Flexibility, and Severity of Symptoms among People with  Irritable Bowel Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84554</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: Individuals are randomly assigned to two intervention and control groups using a random number table. The groups are also matched in terms of the type of medication used and the type of IBS. Patients are asked not to change their lifestyle during the implementation of this intervention and to continue their medical treatment. Then, acceptance and commitment therapy is implemented in 8 sessions of 90 minutes on the experimental group and is not performed on the control group. Finally, the treatment method is compared with the control group in terms of symptom reduction. All participants complete lifestyle and psychological flexibility questionnaires and IBS symptom severity before and after the intervention, Randomization description: In this study, to allocate participants to the experimental and control groups, a simple randomization method was used with a table of random numbers. First, a list of eligible participants was prepared, and each individual was assigned a number. Then, by randomly selecting a starting point in the table of random numbers, the numbers were read in sequence. Based on whether the numbers were even or odd, individuals were allocated to the experimental or control group (even numbers for the experimental group and odd numbers for the control group). This method was implemented to prevent bias in allocation and to increase the internal validity of the research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irritable Bowel Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the intervention group received eight-90 minute sessions of Acceptance and Commitment Therapy. Intervention 2: Control group: Receives no intervention.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Zahra Zanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5510 9999</telephone>
        <email>z-zanjani2005@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Zanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences, Pezeshk Blvd, Qotb Ravandi Blvd, Kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5510 9999</telephone>
        <email>z-zanjani2005@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis IBS based on the criteria of ROME IV
Aged between 18 and 65 years
Satisfaction and commitment to participate in the study
Absence of suicidal thoughts
No prior history of psychotherapy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Get interventions psychological treatment in the past year and the time of the study
Three sessions of absence for each patient.
Oncet of an acute psychological or somatic condition
The individual's unwillingness to continue the session</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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the intervention group received eight-90 minute sessions of Acceptance and Commitment Therapy</i_keyword>
      <i_keyword>Control group: Receives no intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lifestyle. Timepoint: Before and after intervention. Method of measurement: Health-Promoting Lifestyle Profile.</prim_outcome>
      <prim_outcome>Psychological Flexibility. Timepoint: Before and after intervention. Method of measurement: Cognitive flexibility inventory.</prim_outcome>
      <prim_outcome>Severity Symptoms. Timepoint: Before and after intervention. Method of measurement: IBS-SSS.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-06-08</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashanپ Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
