<?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>IRCT20220808055640N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-30</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Acceptance and Commitment Therapy and Intensive Short-Term Dynamic Psychotherapy on Emotion Regulation, Shame and Perfectionism</public_title>
      <acronym>ACT and ISTDP</acronym>
      <scientific_title>Comparison of the Effectiveness of Acceptance and Commitment Therapy and Intensive Short-Term Dynamic Psychotherapy on Emotion Regulation, Shame and Perfectionism among Patients with Irritable Bowel Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65230</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Blinding description: An interventional study with blinding participants is conducted to evaluate the effect of acceptance and commitment therapy and short-term dynamic psychotherapy on emotion regulation, shame and perfectionism in people with irritable bowel syndrome.The method of blinding the patients is that after explaining the research, the treatment is given to the two intervention groups, but the two intervention groups do not know which treatment they will receive.The control group will only receive explanations about the questionnaires and forms that contain the questionnaires used to measure the target variables during the pre-test and post-test. Also, patients do not know the nature of the intervention program implemented for the opposite groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irritable bowel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1, the group receiving acceptance and commitment therapy: Before the intervention, questionnaires were completed by people in the groups. Ten sessions of acceptance and commitment therapy were followed, one session per week and each session lasting about an hour, in a quiet room and according to a written schedule.In this research, the intervention programs of Hayes, 2008 and Dahl, Stewart, Martel and Kaplan, 2014 were adapted.First, in the form of solving general problems, and then solving specific problems and helping clients to recognize ineffective control strategies and realize their futility, accepting painful personal events without fighting with them, teaching the steps of acceptance, explaining the concept of values, creating motivation. It was done to change and train commitment to action that affect the regulation of emotions, feelings of shame and perfectionism of the subject group.The group had enough opportunity to achieve the goals of the research, and the subjects started with freedom of action and without any pressure from the therapist to express their emotions, feelings of shame and perfectionism. At the end of the training, the group was given a post-test and the questionnaires were filled again. Intervention 2: Intervention group2, The group receiving short-term dynamic psychotherapy: before the implementation of the intervention, the questionnaires were completed by people in the groups. For the second experimental group, which were exposed to the experimental variable of short-term dynamic psychotherapy, ten sessions of a one-hour training program were designed based on the works of Dr. Habib Duvanlu (2000). Each part of the treatment consists of a series of intervention and response, which ultimately leads to the failure of resistance and the therapist and patient entering the dynamic and unconscious core of the disorder.The seven stages of the dynamic sequence are: questioning the patient's problem, pressure, challenge with resistance, manifestation of transference resistance and challenge with it, overcoming the therapeutic contract over resistance and conscious re-opening, analysis of transference and exploration of dynamics in the unconscious. At the end of the training, the group was given a post-test and the questionnaires were filled again. Intervention 3: Control group, no intervention: no intervention was done on people. Questionnaires were filled by people at the beginning of the course and filled again at the end of the course.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Considering that the number of patients with irritable bowel syndrome in Fars province is limited, in order to prevent the possible identification of individuals based on their demographic characteristics, the data of these people will be prevented.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nooshin Barahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1,No.45, Alley 12/5, Shaid beheshti Blvd.,</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7145894373</zip>
        <telephone>+98 71 3627 7079</telephone>
        <email>nooshinbarahimi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nooshin Barahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1,No.45, Alley 12/5, Shaid beheshti Blvd.,</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7145894373</zip>
        <telephone>+98 71 3627 7079</telephone>
        <email>nooshinbarahimi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of Irritable Bowel Syndrome by a gastroenterologist
Age group 20 to 45 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>having an addiction
Having a psychological disorders
Psychiatric drug use
having heart and respiratory diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K90-K93</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of the digestive system</hc_keyword>
    </health_condition_keyword>
    <intervention_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 1, the group receiving acceptance and commitment therapy: Before the intervention, questionnaires were completed by people in the groups. Ten sessions of acceptance and commitment therapy were followed, one session per week and each session lasting about an hour, in a quiet room and according to a written schedule.In this research, the intervention programs of Hayes, 2008 and Dahl, Stewart, Martel and Kaplan, 2014 were adapted.First, in the form of solving general problems, and then solving specific problems and helping clients to recognize ineffective control strategies and realize their futility, accepting painful personal events without fighting with them, teaching the steps of acceptance, explaining the concept of values, creating motivation. It was done to change and train commitment to action that affect the regulation of emotions, feelings of shame and perfectionism of the subject group.The group had enough opportunity to achieve the goals of the research, and the subjects started with freedom of action and without any pressure from the therapist to express their emotions, feelings of shame and perfectionism. At the end of the training, the group was given a post-test and the questionnaires were filled again.</i_keyword>
      <i_keyword>Intervention group2, The group receiving short-term dynamic psychotherapy: before the implementation of the intervention, the questionnaires were completed by people in the groups. For the second experimental group, which were exposed to the experimental variable of short-term dynamic psychotherapy, ten sessions of a one-hour training program were designed based on the works of Dr. Habib Duvanlu (2000). Each part of the treatment consists of a series of intervention and response, which ultimately leads to the failure of resistance and the therapist and patient entering the dynamic and unconscious core of the disorder.The seven stages of the dynamic sequence are: questioning the patient's problem, pressure, challenge with resistance, manifestation of transference resistance and challenge with it, overcoming the therapeutic contract over resistance and conscious re-opening, analysis of transference and exploration of dynamics in the unconscious. At the end of the training, the group was given a post-test and the questionnaires were filled again.</i_keyword>
      <i_keyword>Control group, no intervention: no intervention was done on people. Questionnaires were filled by people at the beginning of the course and filled again at the end of the course.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotion regulation score in Gratz &amp; Roemer questionnaire. Timepoint: At the beginning of the study and 10 weeks after the start of the intervention. Method of measurement: Gratz &amp; Roemer Difficulties in Emotion Regulation Scale.</prim_outcome>
      <prim_outcome>Shame score in Cook's questionnaire and Gross et al.'s questionnaire. Timepoint: At the beginning of the study and 10 weeks after the start of the intervention. Method of measurement: Cook Internalized shame scale, Gross et al. Shame scale.</prim_outcome>
      <prim_outcome>Perfectionism score in the Flett perfectionism scale. Timepoint: At the beginning of the study and 10 weeks after the start of the intervention. Method of measurement: Flett Perfectionism 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-08</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand St., central building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
