<?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>IRCT20201107049294N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-20</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of various treatments in reducing psychosomatic symptoms in patients with gastrointestinal dysfunction type D</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Integrative Therapy, Acceptance and Commitment-Based Therapy, Short-term Psychoanalysis in Alexithymia, Distress and Psychosomatic Symptoms in Gastrointestinal Disorder Patients with High Score in the personality type D</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52139</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All 48 participants were sorted alphabetically into a list of 48 people by surname and first name, then using one of the eight random blocks, among possible compositions, which were selected randomly, assigned individuals to 4 groups (three treatment groups and one control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diseases of oesophagus, stomach and duodenum.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First group therapy (integrated treatment).Integrated protocol by integrated protocol by Mollajafar et al. (2017) which is a combination of three therapies (cognitive-behavioral, spiritual therapy and therapy based on acceptance and commitment), in eight sessions of one and a half hours and two sessions per week for A month is formed. The following are the steps of the treatment separately for the training sessions. Intervention 2: Intervention group: Intervention group: Second group therapy (acceptance and commitment based therapy).For acceptance-based behavior therapy, a therapeutic guide was used in the book Acceptance-Based Behavior Therapy by Hysacleton, Roemer, and Arsillo (2011). The treatment sessions consisted of 8 sessions (two sessions per week). The first 4 sessions were aimed at guiding and placing clients in the path of the treatment model, with a time of 90 minutes. The remaining 4 sessions were one hour. Intervention 3: Intervention group: Intervention group: Third group therapy (short-term psychoanalysis).The content of the sessions according to the short-term psychotherapy psychotherapy guideline, ie the seven stages of questions about problems, pressure, challenge, transfer resistance, direct access to the unconscious, transfer analysis, and scanning in the unconscious (Fooladi et al., 2017), are described in Table 4. Is. These sessions were held for two months (two sessions per week). Intervention 4: Control group: Only support counseling program.</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 I am examining its aspects.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 77, Hadadi Alley, Shiva St., Dolab Head Mill. second floor</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1764873673</zip>
        <telephone>+98 21 3305 5284</telephone>
        <email>ali_bakhshi110@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Bakhshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 77, 2nd Floor, Hadadi Alley, Shiva Alley, Doolab Mill Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1764873673</zip>
        <telephone>+98 21 3305 5284</telephone>
        <email>ali_bakhshi110@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient cooperation to participate in the research
complete the consent form
First referral
Minimum cycle education
Age 60-18 years
Patients with gastrointestinal dysfunction according to ROME III criteria by a gastroenterologist for patients referred to a psychiatric clinic
Diagnosis of gastrointestinal dysfunction with irritable bowel syndrome (IBS)
dyspepsia (FD) or both
Do not take psychiatric drugs with the main purpose of reducing emotions (anxiety, etc.)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>A history of substance abuse or dependence is currently on record during the four months prior to treatment
Use of any type of psychiatric and psychiatric medication based on the record in the four months before the first treatment session
Use of any kind of psychological and counseling services for any mental disorder I and II</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K20-K31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of oesophagus, stomach and duodenum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First group therapy (integrated treatment).Integrated protocol by integrated protocol by Mollajafar et al. (2017) which is a combination of three therapies (cognitive-behavioral, spiritual therapy and therapy based on acceptance and commitment), in eight sessions of one and a half hours and two sessions per week for A month is formed. The following are the steps of the treatment separately for the training sessions.</i_keyword>
      <i_keyword>Intervention group: Intervention group: Second group therapy (acceptance and commitment based therapy).For acceptance-based behavior therapy, a therapeutic guide was used in the book Acceptance-Based Behavior Therapy by Hysacleton, Roemer, and Arsillo (2011). The treatment sessions consisted of 8 sessions (two sessions per week). The first 4 sessions were aimed at guiding and placing clients in the path of the treatment model, with a time of 90 minutes. The remaining 4 sessions were one hour.</i_keyword>
      <i_keyword>Intervention group: Intervention group: Third group therapy (short-term psychoanalysis).The content of the sessions according to the short-term psychotherapy psychotherapy guideline, ie the seven stages of questions about problems, pressure, challenge, transfer resistance, direct access to the unconscious, transfer analysis, and scanning in the unconscious (Fooladi et al., 2017), are described in Table 4. Is. These sessions were held for two months (two sessions per week).</i_keyword>
      <i_keyword>Control group: Only support counseling program</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alexithymia. Timepoint: Before starting, after finishing, two months after finishing. Method of measurement: Toronto Alexithymia Scale.</prim_outcome>
      <prim_outcome>Stress-Anxiety. Timepoint: Before starting, after finishing, two months after finishing. Method of measurement: DASS-21 Stress-Anxiety-Depression Inventory.</prim_outcome>
      <prim_outcome>Psychosomatic Symptoms. Timepoint: Before starting, after finishing, two months after finishing. Method of measurement: Takata and Sakata Psychosomatic Complaints Scale.</prim_outcome>
      <prim_outcome>Gastrointestinal Dysfunction. Timepoint: Before starting, after finishing, two months after finishing. Method of measurement: ROME-III 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-11</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>South Khorasan Province, Birjand County, Ayatollah Ghaffari St., University of Medical Sciences Birjand North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
