<?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>IRCT20220907055911N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-29</date_registration>
      <primary_sponsor>Bu-Ali Sina University</primary_sponsor>
      <public_title>The effect of self-compassion on cognitive vulnerability to depression</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Self-Compassion-Focused Therapy on Cognitive Vulnerability to Depression in Students of Bu-Ali Sina University</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>311</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65815</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: It has an experimental group and a control group, the experimental group all underwent the same type of intervention, but the control group did not receive any intervention. Pre-test and post-test were performed on both groups, Randomization description: Sampling was done in two stages; First, for the purpose of screening, 311 series of questionnaires were provided to the students by available sampling method, then according to the criteria of the research, 52 people were screened at this stage. First, 40 people were randomly selected (40 questionnaire codes were selected by lottery from among the 52 available codes), and finally, these 40 people were randomly assigned (again, by lottery from among the 40 available codes, one of the selected codes was assigned to experimental and control groups were assigned), 20 people were in the experimental group and 20 people were in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cognitive Vulnerability to Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental group underwent compassion-focused therapy for 8 sessions of 90 minutes. Neff, defined self-compassion as a three-component construct, which includes kindness to oneself versus self-judgment, human sharing versus isolation, and vigilance versus extreme assimilation. Therefore, Gilbert used this structure in the treatment sessions, and finally proposed self-compassion-focused therapy. In fact, self-compassion-focused therapy focuses on the four areas of past and historical experiences, underlying fears, strategies for being safe, and unintended consequences. self-compassion-focused therapy package was developed and designed based on the theoretical guidelines of Gilbert’s compassionate mind. Session one, purpose: introduction and general explanations. content: familiarity with members, workshop rules, members' goals for attending the meetings, the logic of intervention sessions, the definition of compassion, the importance and the effects of compassion. Session two, purpose: introducing emotional regulation systems. content: introducing three emotional regulation systems and the way they affect the individual; explaining the difference between a threat-focused mind and a compassionate mind. Session three, purpose: introducing mindfulness technique. content: teaching relaxing breath and the way to perform it; introducing mindfulness skills, physical examination techniques, moment-to-moment attention, and conscious eating (e.g., raisin eating practice). Session four, purpose: introducing the characteristics of compassion and a compassionate person. content: explaining the six characteristics of compassion (i.e., sensitivity, well-being care, empathy, sympathy, non-judgment, and tolerance of turmoil); defining a compassionate person and his characteristics (i.e., wisdom, power, kindness, non-judgment, and responsibility); explaining the fact that the client must learn skills in order to become a compassionate person. Session five, purpose: introducing compassionate reasoning and compassionate attention. content: teaching how to visualize self-compassion; imagining your best state; performing the technique of compassionate chair. Session six, purpose: introducing techniques to cultivate a compassionate mind. content: reconstructing hard emotional memories through focusing on compassionate identity; further cultivating the relief system; building a compassionate inner relationship. Session seven, purpose: introducing compassionate feeling (showing compassion to others and receiving compassion from them). content: practicing self-compassion; creating an ideal and complete compassionate model; having a brief reference to the concept of fear of compassion. Session eight, purpose: introducing compassionate behaviors. content: explaining the true meaning of compassionate behaviors; generating ideas for compassionate behaviors; teaching compassionate letter writing and summarizing. Intervention 2: Control group: The control group did not receive any treatment.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Haniyeh Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mostafa Ahmadi Roshan Street</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3838 1601</telephone>
        <email>haniehrahimi95@gmail.com</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehran Farhadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Mostafa Ahmadi Roshan Street</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3838 1601</telephone>
        <email>mehran.farhadi@gmail.com</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All students of Bu-Ali Sina University (Before screening)
The lack of depression symptoms (After screening)
Not receiving psychotherapy services in the past two months (After screening)
These individuals should have a cognitive vulnerability to depression (After screening)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The experimental group underwent compassion-focused therapy for 8 sessions of 90 minutes. Neff, defined self-compassion as a three-component construct, which includes kindness to oneself versus self-judgment, human sharing versus isolation, and vigilance versus extreme assimilation. Therefore, Gilbert used this structure in the treatment sessions, and finally proposed self-compassion-focused therapy. In fact, self-compassion-focused therapy focuses on the four areas of past and historical experiences, underlying fears, strategies for being safe, and unintended consequences. self-compassion-focused therapy package was developed and designed based on the theoretical guidelines of Gilbert’s compassionate mind. Session one, purpose: introduction and general explanations. content: familiarity with members, workshop rules, members' goals for attending the meetings, the logic of intervention sessions, the definition of compassion, the importance and the effects of compassion. Session two, purpose: introducing emotional regulation systems. content: introducing three emotional regulation systems and the way they affect the individual; explaining the difference between a threat-focused mind and a compassionate mind. Session three, purpose: introducing mindfulness technique. content: teaching relaxing breath and the way to perform it; introducing mindfulness skills, physical examination techniques, moment-to-moment attention, and conscious eating (e.g., raisin eating practice). Session four, purpose: introducing the characteristics of compassion and a compassionate person. content: explaining the six characteristics of compassion (i.e., sensitivity, well-being care, empathy, sympathy, non-judgment, and tolerance of turmoil); defining a compassionate person and his characteristics (i.e., wisdom, power, kindness, non-judgment, and responsibility); explaining the fact that the client must learn skills in order to become a compassionate person. Session five, purpose: introducing compassionate reasoning and compassionate attention. content: teaching how to visualize self-compassion; imagining your best state; performing the technique of compassionate chair. Session six, purpose: introducing techniques to cultivate a compassionate mind. content: reconstructing hard emotional memories through focusing on compassionate identity; further cultivating the relief system; building a compassionate inner relationship. Session seven, purpose: introducing compassionate feeling (showing compassion to others and receiving compassion from them). content: practicing self-compassion; creating an ideal and complete compassionate model; having a brief reference to the concept of fear of compassion. Session eight, purpose: introducing compassionate behaviors. content: explaining the true meaning of compassionate behaviors; generating ideas for compassionate behaviors; teaching compassionate letter writing and summarizing.</i_keyword>
      <i_keyword>Control group: The control group did not receive any treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive vulnerability score to depression. Timepoint: Before the start of the intervention and four days  after the end of the intervention. Method of measurement: (According to the score of the Beck Depression Inventory, these people should not be depressed at the time of the intervention (z-scores less than 1) and also according to the scores of the dysfunctional attitude scale (scores of higher than 128), attribution style questionnaire and Cognitive Triad Inventory (z-scores of higher than 1) and self-esteem scale (z-scores lower than 1), these individuals should have cognitive vulnerability to depression.</prim_outcome>
      <prim_outcome>Dysfunctional attitudes score. Timepoint: Before the start of the intervention and four days after the end of the intervention. Method of measurement: Dysfunctional Attitude Scale and Cognitive Triad Inventory.</prim_outcome>
      <prim_outcome>Reducing internal, stable, and general attribution styles in negative situations score. Timepoint: Before the start of the intervention and four days after the end of the intervention. Method of measurement: Attributional Style Questionnaire.</prim_outcome>
      <prim_outcome>Self-esteem score. Timepoint: Before the start of the intervention and four days after the end of the intervention. Method of measurement: Rosenberg Self-Esteem 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>Bu-Ali Sina University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-02</approval_date>
        <contact_name>Ethics committee Hamedan of University of Bu-Ali Sina</contact_name>
        <contact_address>Shahid Mostafa Ahmadi Roshan Street Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
