<?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>IRCT20200808048335N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-01</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The effect of emotion in cardiac Patients</public_title>
      <acronym>EFT</acronym>
      <scientific_title>The Effectiveness of Emotion-Focused Therapy (EFT) on Perceived Stress and alexithymia in Cardiovascular Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50172</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: The method of simple randomization and its unit is individual. People who have the criteria to enter the research are assigned a number. For example, if 50 people have the criteria to enter the research, they are assigned a number from 1 to 50, respectively. The numbers, by lot, are at least 15 for the experimental group and 15 for the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Topics covered include stress, alexithymia, and emotion-focused therapy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Educating patients during 8 training sessions, 90 minutes and one session per week. The content of each session is stated separately.                                                                           1.Communication and Commitment in Treatment, Explaining Heart Disease, Causing and Maintaining Factors, Risk Factors, Describing Group Rules, Discussing Confidentiality, Goals, Type of Emotion Focused Therapy Conceptualization, Assessment of Subjects Based on Ability to Focus On internal experiences 2. Identifying a faulty interactive cycle, identifying conflicting, dualistic, and critical feelings about yourself and important influential people in life     3. Identify basic emotions and express emotion, teach the naming of emotions in the present, discuss the four main emotions and their needs     4. Creating usually unpleasant emotional experiences in communication and family contexts and challenging them, placing the subjects in a two-chair dialogue position to identify the initial hidden emotion and debate between the empiricist and the self-critic                                                                                                       5. The use of relaxation techniques, speech, and self-criticism can be calmed down and the subject's experience of helplessness reduced. Put subjects in an empty chair to talk to influential people in their lives    6. Strengthening positive emotions through the process of forgiveness and self-criticism and its positive effects on patients' cardiac function and increasing awareness of the consequences of delaying the process of forgiveness.  7. Expressing your own values and how to live with them and pointing to emotional and emotional needs and ways to meet those needs in line with values (for example maintaining health as a value)                                                                                                                         8.Review the skills offered and reinforce the changes made during treatment. Highlighting the differences between current and old interactions and summarizing points raised in previous sessions. Intervention 2: Control group:  In this study, the control group will not receive any treatment training.</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 have to decide on it</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Aghelmasjedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the gas office., Imam Reza Blvd. Basij crossroad</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>46916-84144</zip>
        <telephone>+98 11 5523 0511</telephone>
        <email>aghelmasjedi@rahman.ac.ir</email>
        <affiliation>Rahman Institute of Higher Education</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Aghelmasjedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to the gas office., Imam Reza Blvd. Basij crossroad</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>46916-84144</zip>
        <telephone>+98 11 5523 0511</telephone>
        <email>aghelmasjedi@rahman.ac.ir</email>
        <affiliation>Rahman Institute of Higher Education</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>They have Cardiovascular disease
They are relatively stable in terms of Physical and Mental health
They have high Perceived Stress
They have high Alexithymia</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>They have a Mental or other Physical Illness
They have acute and severe symptoms of heart disease
They are under 20 years old or over 55 years old
People who are undergoing other psychological treatment at the same time</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Educating patients during 8 training sessions, 90 minutes and one session per week. The content of each session is stated separately.                                                                           1.Communication and Commitment in Treatment, Explaining Heart Disease, Causing and Maintaining Factors, Risk Factors, Describing Group Rules, Discussing Confidentiality, Goals, Type of Emotion Focused Therapy Conceptualization, Assessment of Subjects Based on Ability to Focus On internal experiences 2. Identifying a faulty interactive cycle, identifying conflicting, dualistic, and critical feelings about yourself and important influential people in life     3. Identify basic emotions and express emotion, teach the naming of emotions in the present, discuss the four main emotions and their needs     4. Creating usually unpleasant emotional experiences in communication and family contexts and challenging them, placing the subjects in a two-chair dialogue position to identify the initial hidden emotion and debate between the empiricist and the self-critic                                                                                                       5. The use of relaxation techniques, speech, and self-criticism can be calmed down and the subject's experience of helplessness reduced. Put subjects in an empty chair to talk to influential people in their lives    6. Strengthening positive emotions through the process of forgiveness and self-criticism and its positive effects on patients' cardiac function and increasing awareness of the consequences of delaying the process of forgiveness.  7. Expressing your own values and how to live with them and pointing to emotional and emotional needs and ways to meet those needs in line with values (for example maintaining health as a value)                                                                                                                         8.Review the skills offered and reinforce the changes made during treatment. Highlighting the differences between current and old interactions and summarizing points raised in previous sessions</i_keyword>
      <i_keyword>Control group:  In this study, the control group will not receive any treatment training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1. alexithymia Score in the Toronto alexithymia Questionnaire. Timepoint: Measurement of alexithymia  at the beginning of the study (before the intervention) and 60 days after the start of treatment (EFT). Method of measurement: Toronto alexithymia Questionnaire.</prim_outcome>
      <prim_outcome>2. Perceived Stress Score in the Perceptual Stress Questionnaire Cohen et al. Timepoint: Measurement of perceived stress at the beginning of the study (before the intervention) and 60 days after the start of treatment (EFT). Method of measurement: Perceived Stress Questionnaire by Cohen et al.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-01</approval_date>
        <contact_name>Ethics committee of Rasht University of Medical Sciences</contact_name>
        <contact_address>Namjoo Ave., Shahid Siadati St., Rasht., Technology &amp; Research Vice-chancellor of University Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
