<?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>IRCT20220316054306N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-25</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of compassion-based therapy and  acceptance and commitment therapy on the psychological symptoms of  peptic ulcer patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of online group compassion-based therapy and  acceptance and commitment therapy on the psychological symptoms of patients with peptic ulcer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77959</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All the people who entered the study were given a code, then these codes were entered into the Randomly assign online software (https://www.graphpad.com/quickcalcs/randomize1.cfm) and the software randomly assigned each code to a group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Peptic ulcer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Psychotherapy sessions based on acceptance and commitment: The sessions will be conducted online and consist of 6 sessions, each lasting 90 minutes. First session: Establishing communication and introducing participants to the intervention topic. Second session: Discussing the temporary and ineffectiveness of methods using metaphors. Third session: Identifying ineffective strategies and accepting painful personal events. Fourth session: Explaining the avoidance of painful experiences and raising awareness about their consequences. Fifth session: Examining the interconnected relationship between behavior, emotions, and cognition. Sixth session: Explaining the concepts of role and context, introducing the concept of values, and creating motivation for change and commitment to action. Intervention 2: Intervention group: Self-compassion-based psychotherapy group meetings will be conducted online in six 90-minute sessions. The first session will focus on introducing the concept of compassion and its importance in life. In the second session, participants will be taught ways to enhance positive experiences, increase awareness of positive experiences, create positive experiences through mental visualization, and learn about compassionate behaviors. The third session will involve training in identifying negative self-evaluations and their impact on compassion. During the fourth session, participants will receive training on recognizing how and to what extent they practice compassion. The fifth session will focus on cultivating self-compassion through conscious attention. In the final session, participants will receive training on transforming negative self-compassion by engaging in behaviors that counteract those negative feelings. Intervention 3: Control group: 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>Amir Sam Kianimoghadam</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>kianimoghadam@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 peptic ulcer diagnosed by a gastroenterologist
Age between 18 and 60 years
At least having diploma degree
Ability to use smartphones</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>having neurological disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K27</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Peptic ulcer, site unspecified</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: Psychotherapy sessions based on acceptance and commitment: The sessions will be conducted online and consist of 6 sessions, each lasting 90 minutes. First session: Establishing communication and introducing participants to the intervention topic. Second session: Discussing the temporary and ineffectiveness of methods using metaphors. Third session: Identifying ineffective strategies and accepting painful personal events. Fourth session: Explaining the avoidance of painful experiences and raising awareness about their consequences. Fifth session: Examining the interconnected relationship between behavior, emotions, and cognition. Sixth session: Explaining the concepts of role and context, introducing the concept of values, and creating motivation for change and commitment to action.</i_keyword>
      <i_keyword>Intervention group: Self-compassion-based psychotherapy group meetings will be conducted online in six 90-minute sessions. The first session will focus on introducing the concept of compassion and its importance in life. In the second session, participants will be taught ways to enhance positive experiences, increase awareness of positive experiences, create positive experiences through mental visualization, and learn about compassionate behaviors. The third session will involve training in identifying negative self-evaluations and their impact on compassion. During the fourth session, participants will receive training on recognizing how and to what extent they practice compassion. The fifth session will focus on cultivating self-compassion through conscious attention. In the final session, participants will receive training on transforming negative self-compassion by engaging in behaviors that counteract those negative feelings.</i_keyword>
      <i_keyword>Control group: 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 Depression Anxiety Stress Scales.</prim_outcome>
      <prim_outcome>Severity of anxiety symptoms. Timepoint: Before and after intervention. Method of measurement: Depression Anxiety Stress Scales.</prim_outcome>
      <prim_outcome>Severity of stress. Timepoint: Before and after intervention. Method of measurement: Depression Anxiety Stress Scales.</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>
    </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>2024-06-18</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 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
