<?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>IRCT20220530055024N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-05</date_registration>
      <primary_sponsor>, Islamic Azad University Of Najafabad</primary_sponsor>
      <public_title>Comparison of the effectiveness of mentalization and emotion regulation in the level of self-compassion and resilience of nurses</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of metallization-based therapy and emotion-regulated therapy based on the Gross process model on self-compassion and resilience in Critical Care Unit Nurses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63857</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Other design features: The present study is a quasi-experimental study with two experimental groups and one control group. The statistical population of nurses working in intensive care units of educational and medical centers affiliated to Tehran University of Medical Sciences in 1401, of which 45 people in three groups are randomly assigned. in this research. Nurses are divided into three groups (15 people in the group based on mentalization therapy, 15 people in the group based on emotion regulation therapy and 15 people in the control group). The test groups each receive eight 90-minute sessions separately. Data collection tools are self-compassion and resilience scale questionnaires, Randomization description: Simple randomization with statistical software through the website (https://www.Randomization.com) was used online for random allocation. (One of the accepted methods of random sequence generation is the use of web randomization. It is available to researchers for free.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Self-compassion / resilience.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group of mentalization-based therapy: Mentalization-based therapy is one of the psychological therapies. According to the treatment protocol set by Batman and Funagi, it is performed in 8 sessions of 90 minutes in the form of psychological counseling sessions. Has been described as the ability of a person to understand or explain his or her behavior or that of others, and is based on the school of object relations and attachment theory. Interpret, infer, imagine, simulate, recall, reflect and predict. Intervention 2: Intervention group 2: Emotion regulation therapy: Emotion regulation therapy is one of the psychological therapies, which is based on the Gross process model. This protocol is performed in 8 sessions of 90 minutes in the form of psychological counseling sessions. Recognizing emotion and motivating situations, differentiating the performance of different types of emotions, information about different dimensions of emotion and short-term and long-term effects of emotions, identifying the level of emotional vulnerability in the individual, problem-solving strategy training, interpersonal skills (dialogue, expression and conflict resolution) Stopping rumination and worrying, as well as identifying miscalculations and their effects on emotional states, identifying the extent and manner of using the inhibition strategy and examining its emotional consequences (exposure, training to express emotion, modifying behavior by changing environmental enhancers, Emotion relief training, relaxation, and reverse practice) and ultimately the application of skills learned in natural environments outside of the treatment session. Intervention 3: Control group: The control group did not receive 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 There is no more information. "</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sheida Jabalameli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gol e narges residency complex - apartment no 22A - building no 47 - Albirz alley - Seyed mofidi st ( koohsar area ) - Darakeh - Tehran - iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۳۹۶۱۴۴۸۴</zip>
        <telephone>+98 21 2264 7935</telephone>
        <email>soheilasalmanian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sheida Jabalameli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gol e narges residency complex - apartment no 22A - building no 47 - Albirz alley - Seyed mofidi st ( koohsar area ) - Darakeh - Tehran - iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۳۹۶۱۴۴۸۴</zip>
        <telephone>+98 21 2264 7935</telephone>
        <email>soheilasalmanian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Bachelor and senior nurse of the special ward working in the CCU or ICU
consent to participate in research and lack of physical disability or incapacitated disease
(in the age range of employees, 22-50 years) in Tehran hospitals,</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria are: the person is absent for 2 sessions or more,
does not cooperate during work and does not complete questionnaires
has a debilitating illness.</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group of mentalization-based therapy: Mentalization-based therapy is one of the psychological therapies. According to the treatment protocol set by Batman and Funagi, it is performed in 8 sessions of 90 minutes in the form of psychological counseling sessions. Has been described as the ability of a person to understand or explain his or her behavior or that of others, and is based on the school of object relations and attachment theory. Interpret, infer, imagine, simulate, recall, reflect and predict.</i_keyword>
      <i_keyword>Intervention group 2: Emotion regulation therapy: Emotion regulation therapy is one of the psychological therapies, which is based on the Gross process model. This protocol is performed in 8 sessions of 90 minutes in the form of psychological counseling sessions. Recognizing emotion and motivating situations, differentiating the performance of different types of emotions, information about different dimensions of emotion and short-term and long-term effects of emotions, identifying the level of emotional vulnerability in the individual, problem-solving strategy training, interpersonal skills (dialogue, expression and conflict resolution) Stopping rumination and worrying, as well as identifying miscalculations and their effects on emotional states, identifying the extent and manner of using the inhibition strategy and examining its emotional consequences (exposure, training to express emotion, modifying behavior by changing environmental enhancers, Emotion relief training, relaxation, and reverse practice) and ultimately the application of skills learned in natural environments outside of the treatment session.</i_keyword>
      <i_keyword>Control group: The control group did not receive training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of 26-choice self-compassion questionnaire. Self-Compassion Questionnaire: The Self-Compassion Questionnaire includes 26 items and 6 components of self-compassion, self-judgment, human sharing, isolation, awareness or extreme awareness and imitation in a 5-point Likert scale from strongly disagree = 1 to strongly agree = 5 is scored. The six components of self-kindness (5 articles), self-judgment (5 articles), human sharing (4 articles) against isolation (4 articles) and mindfulness (4 articles) against extreme imitation (4 articles) have been formulated. The higher the score the higher the level of compassion shown. Articles 1, 4, 8, 9, 11 and 12 are also scored in reverse. Reliability of Compassion Questionnaire Alpha coefficient for overall score of 0.91 scale. Timepoint: The interventions are held in the form of one-and-a-half-hour weekly sessions for 8 sessions continuously.Compassion measurement sections are performed as pre-test (before intervention) and post-test (after intervention). Method of measurement: The Compassion Questionnaire consists of 26 items and 6 components in a 5-point Likert scale from strongly disagree = 1 to strongly agree = 5. The higher the score the higher the level of compassion shown. Articles 1, 4, 8, 9, 11 and 12 are also scored in reverse.</prim_outcome>
      <prim_outcome>25-item resilience questionnaire score.Resilience Scale: Connor and Davidson Resilience Questionnaire is 25 items. Examination of descriptive indicators of resilience scores showed that the minimum score is 18 and the maximum score is 94. In this questionnaire, each item is scored on a Likert scale between zero (completely incorrect) and five (completely correct). To get the total score of the questionnaire, the total score of all the questions is added together. This score will range from 0 to 100. The higher the score, the more resilient the respondent will be, and vice versa. This questionnaire has been studied to assess the resilience factors in people at risk of substance abuse and the resilience of Connor and Davidson with Cronbach's alpha has been reported as 0.89. Timepoint: The interventions are held in the form of one-and-a-half-hour weekly sessions for 8 sessions continuously.Resistance measurement sections are performed as pre-test (before intervention) and post-test (after intervention). Method of measurement: The Resonance Scale of the Connor &amp; Davidson Resilience Questionnaire is 25. Each item is scored on a Likert scale between zero (completely incorrect) and five (completely correct). To get the total score of the questionnaire, the total score of all the questions is added together. This score will range from 0 to 100. The higher the score, the more resilient the respondent will be, and vice versa.</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 Of Najafabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-10</approval_date>
        <contact_name>Research Ethics Committees  of  Islamic Azad University- Falavarjan Branch</contact_name>
        <contact_address>Gol e narges residency complex - apartment no 22A - building no 47 - Albirz alley - Seyed mofidi st ( koohsar area ) - Darakeh - Tehran - iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
