<?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>IRCT20220706055396N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of MBCT On Female Adolescents' Repetitive Negative Thoughts, Anxiety and Depression</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Mindfulness-based Cognitive Therapy on Repetitive Negative Thoughts and Anxiety and Depression in Female Adolescents with comorbid Anxiety and Depression Disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64636</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Not noted, Randomization description: Randomization method
In order to select a school in this study, a specific number is assigned to each school (with secondary education) and then, the desired school is chosen through drawing. Furthermore, a certain number is assigned to each member of the study sample for random selection of examination and control groups, and then, drawing is once again used to allocate each number to the control or study groups. The rand function of Excel software is utilized for random allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Rumination. Condition 2: Anxiety. Condition 3: Depression.</hc_freetext>
      <i_freetext>Intervention 1: The Intervention with cognitive therapy based on mindfulness is implemented on the experimental group in the counseling center for 10 sessions of 60 minutes (one session per week). Here is a brief description of the topics of each session: first session: getting to know one another, second session: moving from living passively, to living consciously and with a conscious decision, third session: moving from connecting with experiences through thinking, to feeling those experiences directly, fourth session: Passing from being present in the past and future to being fully present in the moment. Fifth session: Moving from avoiding, escaping, or getting rid of unpleasant experiences to a desire to touch all experiences. Sixth session: passing from depending on the existence of differences, to accepting everything as it is. Seventh session: Moving from considering thoughts as reality to considering them as mental events that may not correspond to reality. Eighth session: Moving from being strict with oneself to taking care of oneself with kindness and compassion. Ninth session: Planning for a Mindful Future. Tenth session: reviewing previous sessions and summarizing. Intervention 2: Control group: No intervention is performed for the control group and it will undergo post-test.</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 No further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Neda BazrAfshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University campus</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>983513137111</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>nedabazrafshan647@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda BazrAfshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University campus</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>983513137111</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>nedabazrafshan647@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The simultaneous presence of clinically significant anxiety disorder and depression, based on questionnaires and interviews
consent to participate in the research</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>17 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Receiving any type of psychotherapy or medication at the same time for the desired emotional problems
Receiving cognitive therapy based on mindfulness so far
participant's unwillingness to continue the treatment process</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The Intervention with cognitive therapy based on mindfulness is implemented on the experimental group in the counseling center for 10 sessions of 60 minutes (one session per week). Here is a brief description of the topics of each session: first session: getting to know one another, second session: moving from living passively, to living consciously and with a conscious decision, third session: moving from connecting with experiences through thinking, to feeling those experiences directly, fourth session: Passing from being present in the past and future to being fully present in the moment. Fifth session: Moving from avoiding, escaping, or getting rid of unpleasant experiences to a desire to touch all experiences. Sixth session: passing from depending on the existence of differences, to accepting everything as it is. Seventh session: Moving from considering thoughts as reality to considering them as mental events that may not correspond to reality. Eighth session: Moving from being strict with oneself to taking care of oneself with kindness and compassion. Ninth session: Planning for a Mindful Future. Tenth session: reviewing previous sessions and summarizing.</i_keyword>
      <i_keyword>Control group: No intervention is performed for the control group and it will undergo post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rumination. Timepoint: Repetitive negative thoughts (Rumination) are measured in the experimental group once before the intervention and once one month after the intervention. No measurement is carried out in the control group. Method of measurement: Questionnaire of repetitive negative thoughts.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: Anxiety is measured in the experimental group once before the intervention and once one month after the intervention. No measurement is done in the control group. Method of measurement: Questionnaire of OASIS.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Depression in the experimental group is measured once before the intervention and once one month after the intervention. No measurement is done regarding the control group. Method of measurement: Questionnaire of ODSIS.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-19</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Semnan branch</contact_name>
        <contact_address>University town,  Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
