<?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>IRCT20201103049252N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-15</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of emotion regulation training on stress coping styles, problem solving, alexithymia, quality of life and pain intensity in patients with peptic ulcer</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of emotion regulation training on stress coping styles, problem solving, alexithymia, quality of life and pain intensity in patients with peptic ulcer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Blinding description: Using another person for treatment.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Ulcer peptic.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Excitement regulation protocol           This protocol is based on Brooks' 1980 treatment for duodenal ulcer.All patients will receive a manual designed to complete the treatment process. Patients in the treatment group will receive a handbook that (A) Explain the rationale of the treatment plan in terms of the relationship between anxiety, emotional inhibition, and gastric ulcer.B) Graphically shows the constant cycle of worry and anxiety. (C) Identifies several main irrational beliefs that lead to unnecessary anxiety. (D) provide examples of negative self-talk, positive self-talk, and general self-confrontation. E) Explained the concept of decisiveness. (F) provide examples of indecisive, aggressive, and assertive behaviors. (G) Provide space for recording important experiences with newly learned behaviors. And (h) provide charts for recording daily wound pain during the follow-up period.The handbook for control patients will include only (a) a general description of the relationship between anxiety, emotional control, and gastric ulcer, and (b) diagrams for recording daily ulcer pain during the follow-up period.The emotional skills training program consisted of eight 60-90 minute treatment sessions that will be conducted separately with the patients in the treatment group. All treatments will be performed by the first author. Patients will receive four sessions of treatment focusing on anxiety management training and four sessions of rigorous training.Anxiety Management Training: The anxiety management section of the program will follow the proposal of Richardson (1976) and typically, the first four of the eight treatment sessions will be devoted to training. During an initial training phase, the patient, with the help of the therapist (a), examined their irrational, erroneous, and anxious beliefs (Ellis, 1973; Richardson), and negative self-talk about a variety of everyday stressful situations. Will identify and (b) develop and write examples of meaningful, alternative, more realistic, and relaxing personal beliefs and conversations with oneself.Training for courage and assertiveness of emotions: The second 4 sessions will be dedicated to this training. The component of teaching courage and emphatic expression of emotions The emotional skills training program will follow the broad format proposed by Lazarus (1971). The two main stages of this component were (a) cognitive reconstruction focusing on correcting misconceptions about assertiveness and the consequences of non-judgment (with particular reference to wound problems) and (b) practicing the behavior of relevant situations in patients' daily homes and workplaces.  For example, most wound patients will report irreversible behaviors in interpersonal situations as a way to "control" emotions and avoid emotional distress (as directed by the therapist). Much of the courage training time will be spent pointing to the need to learn self-awareness, and chronic resentment will be severely emphasized by periodic outbursts of anger and subsequent stressful guilt. Intervention 2: Control group: Treatment az Usual will be performed in the control group. In this group, once a week for 15 minutes for 6 weeks, the therapist will be in contact with patients, but there will be no major psychological interventions. In this group of patients, attention placebo treatment will be performed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is accessible to defined individuals

When:
Start of access period of the year 2022

To whom:
Only for researchers working in academic and scientific institutions

Conditions:
Review of documents for publishing research articles

Where to obtain:
Researchers present in the research

How to obtain:
Documents for publishing an article in a journal

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Asie Eftekhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Velenjak St. , Shahid Chamran Highway</address>
        <city>Tehran</city>
        <country1>Argentina</country1>
        <zip>1985717443</zip>
        <telephone>02123871</telephone>
        <email>Asie.eftekhari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas masjedi arani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 23871</telephone>
        <email>asie.eftekhari@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 ulcer peptic</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Psychotic disordr</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K27.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute peptic ulcer, site unspecified, with both hemorrhage and perforation</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:Excitement regulation protocol           This protocol is based on Brooks' 1980 treatment for duodenal ulcer.All patients will receive a manual designed to complete the treatment process. Patients in the treatment group will receive a handbook that (A) Explain the rationale of the treatment plan in terms of the relationship between anxiety, emotional inhibition, and gastric ulcer.B) Graphically shows the constant cycle of worry and anxiety. (C) Identifies several main irrational beliefs that lead to unnecessary anxiety. (D) provide examples of negative self-talk, positive self-talk, and general self-confrontation. E) Explained the concept of decisiveness. (F) provide examples of indecisive, aggressive, and assertive behaviors. (G) Provide space for recording important experiences with newly learned behaviors. And (h) provide charts for recording daily wound pain during the follow-up period.The handbook for control patients will include only (a) a general description of the relationship between anxiety, emotional control, and gastric ulcer, and (b) diagrams for recording daily ulcer pain during the follow-up period.The emotional skills training program consisted of eight 60-90 minute treatment sessions that will be conducted separately with the patients in the treatment group. All treatments will be performed by the first author. Patients will receive four sessions of treatment focusing on anxiety management training and four sessions of rigorous training.Anxiety Management Training: The anxiety management section of the program will follow the proposal of Richardson (1976) and typically, the first four of the eight treatment sessions will be devoted to training. During an initial training phase, the patient, with the help of the therapist (a), examined their irrational, erroneous, and anxious beliefs (Ellis, 1973; Richardson), and negative self-talk about a variety of everyday stressful situations. Will identify and (b) develop and write examples of meaningful, alternative, more realistic, and relaxing personal beliefs and conversations with oneself.Training for courage and assertiveness of emotions: The second 4 sessions will be dedicated to this training. The component of teaching courage and emphatic expression of emotions The emotional skills training program will follow the broad format proposed by Lazarus (1971). The two main stages of this component were (a) cognitive reconstruction focusing on correcting misconceptions about assertiveness and the consequences of non-judgment (with particular reference to wound problems) and (b) practicing the behavior of relevant situations in patients' daily homes and workplaces.  For example, most wound patients will report irreversible behaviors in interpersonal situations as a way to "control" emotions and avoid emotional distress (as directed by the therapist). Much of the courage training time will be spent pointing to the need to learn self-awareness, and chronic resentment will be severely emphasized by periodic outbursts of anger and subsequent stressful guilt.</i_keyword>
      <i_keyword>Control group: Treatment az Usual will be performed in the control group. In this group, once a week for 15 minutes for 6 weeks, the therapist will be in contact with patients, but there will be no major psychological interventions. In this group of patients, attention placebo treatment will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychotherapy. Timepoint: 3 month. Method of measurement: Questionnaire.</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>2021-10-26</approval_date>
        <contact_name>Ethics committee of shahid beheshti University of Medical Sciences</contact_name>
        <contact_address>Yaman blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
