<?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>IRCT20171203037723N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-08</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The study of effect meta-cognitive skills training  based -on mindfulness on lupus patients</public_title>
      <acronym></acronym>
      <scientific_title>The study of effects   meta-cognitive skills training  based -on mindfulness  on depression, anxiety, stress and well being of systemic lupus erythematosus patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34343</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: For each patient referring to the nephrology clinic after considering the inclusion and exclusion criteria of a number 60 patients are selected through random sampling  (simple randomization ) from the existing numbers.  Patients according to the extra numbers In the lottery,  are included in the study. After selecting these 60 patients, a randomized table of numbers for these patients will be allocated to two groups of 30 (intervention and control).</study_design>
      <phase>N/A</phase>
      <hc_freetext>systemic lupus erythmatosus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  includes people with lupus disease. The intervention was conducted in 8 sessions of 60 minutes in a group with a manual approved by the psychiatrist, psychiatrist and doctor of clinical psychology and in the presence of a clinical psychologist under the supervision of the supervisor.Intervention of  Meta-cognitive Skills Training based mindfulness, including familiarity with cognitive-attention syndrome, rumination and maladaptive coping behaviors, and how to postpone rumination, familiarity with the attention training  technique, familiarity with the examination technique, familiarity with the respiratory meditation technique  , Familiarity with the automatic guidance technique , familiarity with the free association method and familiarity with the cloud illustration method. Intervention 2: Control group:Includes people with lupus disease and there is no intervention in them.</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 need time to make decisions</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamideh Azimi Lolaty</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vesal Shirazi Avenue, Amir Mazandaran Boulevard, Sari Town</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3367 7343</telephone>
        <email>azimihamideh@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamideh Azimi Lolaty</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vesal Shirazi Avenue, Amir Mazandaran Boulevard, Sari Town</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3367 7343</telephone>
        <email>azimihamideh@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 16-55 years with Systemic Lupus Erythematosus
Having at least third degree
Not having mental disorders such as major depressive disorder and anxiety disorder in the past six months (using available information in the case)
To be willing to participate in this research</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Being in the acute phase of the disease
Previous experience in  meta-cognitive skills training  based -on mindfulness classes
No consent to attend training sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Systemic lupus erythematosus (SLE)</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:  includes people with lupus disease. The intervention was conducted in 8 sessions of 60 minutes in a group with a manual approved by the psychiatrist, psychiatrist and doctor of clinical psychology and in the presence of a clinical psychologist under the supervision of the supervisor.Intervention of  Meta-cognitive Skills Training based mindfulness, including familiarity with cognitive-attention syndrome, rumination and maladaptive coping behaviors, and how to postpone rumination, familiarity with the attention training  technique, familiarity with the examination technique, familiarity with the respiratory meditation technique  , Familiarity with the automatic guidance technique , familiarity with the free association method and familiarity with the cloud illustration method.</i_keyword>
      <i_keyword>Control group:Includes people with lupus disease and there is no intervention in them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score&gt; = 14. Timepoint: Before Intervention - After Intervention - Two Month After Intervention. Method of measurement: Depression,Anxiety Stress Scale(DASS).</prim_outcome>
      <prim_outcome>Anxiety score&gt; = 10. Timepoint: Before Intervention - After Intervention - Two Month After Intervention. Method of measurement: Depression,Anxiety Stress Scale(DASS).</prim_outcome>
      <prim_outcome>Stress score&gt; = 19. Timepoint: Before Intervention - After Intervention - Two Month After Intervention. Method of measurement: Depression,Anxiety Stress Scale(DASS).</prim_outcome>
      <prim_outcome>Well being score&gt; = 11. Timepoint: Before Intervention - After Intervention - Two Month After Intervention. Method of measurement: yeild Psychological well-being questionnaire.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-25</approval_date>
        <contact_name>Ethics committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>central headquarters of Mazandaran University of Medical Sciences and Health Services , the beginning of Valiasr highway , Sari Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
