<?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>IRCT20220316054306N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-26</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of cognitive behavioral therapy on the psychological symptoms of celiac patients</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study of the effectiveness of online cognitive behavioral therapy and mindfulness cognitive behavioral therapy on the psychological symptoms of celiac patients with the control group.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78679</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A code will be assigned to the people entering the study, and then each code will be randomly assigned to a group using the random list generator tool.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Celiac disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive behavioral therapy will be administered in the form of weekly 45-minute sessions over the course of eight weeks. During the first session, we will explore the rationale behind the treatment, negative automatic thoughts, and emotional inhibitions. Sessions 2 to 6 will focus on addressing dysfunctional thoughts and attitudes related to celiac disease. The final two sessions will involve the implementation of cognitive behavioral therapy techniques, such as creating flashcards to reinforce positive thoughts, and developing a plan to prevent relapse. Intervention 2: Intervention group: The cognitive behavioral therapy will be based on mindfulness and will consist of 4 sessions, each lasting 75 minutes, with one session per week. In the first session, the therapist will introduce the treatment process and teach clients muscle relaxation and physical awareness. The second session will focus on teaching breathing mindfulness and discussing any obstacles to mindfulness with the clients. The third session will involve teaching and practicing physical examination while reviewing homework. The final session will include practicing silence and immobility exercises, as well as evaluating the progress of the treatment. Intervention 3: Control group:  Waiting list. Patients in this group do not receive any therapy.</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>Shahab Lotfinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.13, Asadimanesh ave, Monireih Blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 23871</telephone>
        <email>lotfiniashahab@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2243 9770</telephone>
        <email>lotfiniashahab@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having celiac disease diagnosed by a gastroenterologist
Age between 18 and 60 years
At least having diploma degree
Ability to use smartphones
Not having neurological disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Celiac disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cognitive behavioral therapy will be administered in the form of weekly 45-minute sessions over the course of eight weeks. During the first session, we will explore the rationale behind the treatment, negative automatic thoughts, and emotional inhibitions. Sessions 2 to 6 will focus on addressing dysfunctional thoughts and attitudes related to celiac disease. The final two sessions will involve the implementation of cognitive behavioral therapy techniques, such as creating flashcards to reinforce positive thoughts, and developing a plan to prevent relapse</i_keyword>
      <i_keyword>Intervention group: The cognitive behavioral therapy will be based on mindfulness and will consist of 4 sessions, each lasting 75 minutes, with one session per week. In the first session, the therapist will introduce the treatment process and teach clients muscle relaxation and physical awareness. The second session will focus on teaching breathing mindfulness and discussing any obstacles to mindfulness with the clients. The third session will involve teaching and practicing physical examination while reviewing homework. The final session will include practicing silence and immobility exercises, as well as evaluating the progress of the treatment.</i_keyword>
      <i_keyword>Control group:  Waiting list. Patients in this group do not receive any therapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of depressive symptoms. Timepoint: Before and after intervention. Method of measurement: Based on the score obtained in the Hospital Anxiety and Depression Scale.</prim_outcome>
      <prim_outcome>Severity of anxiety symptoms. Timepoint: Before and after intervention. Method of measurement: Based on the score obtained in the Hospital Anxiety and Depression Scale.</prim_outcome>
      <prim_outcome>The amount of quality of life. Timepoint: Before and after intervention. Method of measurement: Based on the score obtained in the World Health Organization Quality of Life Scale.</prim_outcome>
      <prim_outcome>The amount of self-compassion. Timepoint: Before and after intervention. Method of measurement: Based on the score obtained in the Self Compassion scale.</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>2024-02-20</approval_date>
        <contact_name>Ethic committee of Shahid Beheshti University of Medical Science</contact_name>
        <contact_address>Bldg No.2 Shahid Beheshti University of Medical science, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Tehranتهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
