<?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>IRCT20120612010008N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-29</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Effect of Mindfulness Based of Cognitive Therapy on Well-being</public_title>
      <acronym></acronym>
      <scientific_title>Study of Well-being Changes During Mindfulness Based of Cognitive Therapy  in Students : a Process of Change Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10508</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The present study examines the  process of change Through the multilevel analysis method, Randomization description: Simple randomization using random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Students with emotional symptoms who do not have the severity to diagnose a clinical disorder based on a psychological distress scale(K10).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1,  Performing 2 Weeks of Mindfulness based cognitive therapy(• Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing). Intervention 2: Intervention group 2, Performing 4 Weeks of Mindfulness based cognitive therapy( Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing• Week 3—Moving from dwelling in the past and future to being fully in the presentmoment• Week 4—Moving from trying to avoid, escape, or get rid of unpleasant experienceto approaching it with interest•). Intervention 3: Intervention group3, Performing 6 Weeks of Mindfulness based cognitive therapy(• Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing• Week 3—Moving from dwelling in the past and future to being fully in the presentmoment• Week 4—Moving from trying to avoid, escape, or get rid of unpleasant experienceto approaching it with interest• Week 5—Moving from needing things to be different to allowing them to be justas they already are• Week 6—Moving from seeing thoughts as facts and real to seeing them as mentalevents that may not correspond to reality• ). Intervention 4: Intervention group 4,  Performing 8 Weeks of Mindfulness based cognitive therapy(• Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing• Week 3—Moving from dwelling in the past and future to being fully in the presentmoment• Week 4—Moving from trying to avoid, escape, or get rid of unpleasant experienceto approaching it with interest• Week 5—Moving from needing things to be different to allowing them to be justas they already are• Week 6—Moving from seeing thoughts as facts and real to seeing them as mentalevents that may not correspond to reality• Week 7—Moving from treating yourself harshly to taking care of yourself withkindness and compassion• Week 8—Planning a mindful future).</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>Elham Aghaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Tehran- Ghom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3319118651</zip>
        <telephone>+98 21 5121 5080</telephone>
        <email>elhamaghaei87@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Aghaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Tehran- Ghom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33191​18651</zip>
        <telephone>+98 21 51210</telephone>
        <email>elhamaghaei87@yahoo.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All students aged 18 to 23 years
Undergraduate students
Living at the Girl's dormitory at Shahed University
Get at least 12 points in the Psychological distress questionnaire ( K10).
Agreement to participate in studying and signing written consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>23 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Get any psychological and Psychiatry treatment in the last 6 months
Earning score  more than 27 points in the Psychological distress questionnaire ( K10).</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1,  Performing 2 Weeks of Mindfulness based cognitive therapy(• Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing)</i_keyword>
      <i_keyword>Intervention group 2, Performing 4 Weeks of Mindfulness based cognitive therapy( Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing• Week 3—Moving from dwelling in the past and future to being fully in the presentmoment• Week 4—Moving from trying to avoid, escape, or get rid of unpleasant experienceto approaching it with interest•)</i_keyword>
      <i_keyword>Intervention group3, Performing 6 Weeks of Mindfulness based cognitive therapy(• Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing• Week 3—Moving from dwelling in the past and future to being fully in the presentmoment• Week 4—Moving from trying to avoid, escape, or get rid of unpleasant experienceto approaching it with interest• Week 5—Moving from needing things to be different to allowing them to be justas they already are• Week 6—Moving from seeing thoughts as facts and real to seeing them as mentalevents that may not correspond to reality• )</i_keyword>
      <i_keyword>Intervention group 4,  Performing 8 Weeks of Mindfulness based cognitive therapy(• Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing• Week 3—Moving from dwelling in the past and future to being fully in the presentmoment• Week 4—Moving from trying to avoid, escape, or get rid of unpleasant experienceto approaching it with interest• Week 5—Moving from needing things to be different to allowing them to be justas they already are• Week 6—Moving from seeing thoughts as facts and real to seeing them as mentalevents that may not correspond to reality• Week 7—Moving from treating yourself harshly to taking care of yourself withkindness and compassion• Week 8—Planning a mindful future)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Well-being. Timepoint: before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks. Method of measurement: Ryffs Scales of Psychological Well-being.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Decentralization. Timepoint: before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks. Method of measurement: experiences questionnaire.</sec_outcome>
      <sec_outcome>Broad attention. Timepoint: before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks. Method of measurement: Alternate uses task.</sec_outcome>
      <sec_outcome>Positive reappraisal. Timepoint: before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks. Method of measurement: cognitive emotional regulation questionnaire.</sec_outcome>
      <sec_outcome>Savoring. Timepoint: before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks. Method of measurement: Savoring Beliefs Inventory.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-22</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Shahed University, Tehran- Ghom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
