<?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>IRCT20180922041082N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-28</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Mindfulness-Integrated Cognitive Behaviour Therapy and Schema Therapy on the Emotional States and the Quality of life of People with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Mindfulness-Integrated Cognitive Behaviour Therapy and Schema Therapy on the Emotional States and the Quality of life of People with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>55</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36533</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The present research is a semi-experimental design with pre-test and post-test with the control group, Randomization description: At first, referred to the Kerman province, ms patients were invited to attend in intervention. Then, among those who enrolled, they were randomly selected and drawn into two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Multiple sclerosis. Condition 2: Emotional states (depression, anxiety, stress).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Mindfulness integrated cognitive behavioral therapy (MICBT) in 8 sessions based on Cayon protocol. Intervention 2: Intervention group: Group Schema Consulting Group in 12 sessions based on the Yang Protocol (2003). Intervention 3: Control group: no treatment has been applied.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
the data are collected anonymously

When:
in case of request the data are available anonymous

To whom:
the further researchers with credible studies from reputable constitutions

Conditions:
researchers with credible studies from reputable constitutions

Where to obtain:
after the article got published

How to obtain:
contact with the corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoud Fazilat pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Blv</address>
        <city>کرمان</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616914111</zip>
        <telephone>+98 34 3132 2393</telephone>
        <email>fazilatm@uk.ac.ir</email>
        <affiliation>Shaid Bahonar University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoud Fazilatpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Highway, Pajoohesh Sq., Shahid Bahonar University, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913439</zip>
        <telephone>+98 34332571415</telephone>
        <email>Fazilatm@uk.ac.ir</email>
        <affiliation>Shahid Bahonar university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being patient based on Neurologist diagnosis
no addiction
Non-use of psychiatric medication simultaneously with the intervention
Not using other psychological treatments  simultaneously with the intervention</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to perform treatment exercises
Abandoned Over-Allowed</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
      <hc_code>R45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
      <hc_keyword>Symptoms and signs involving emotional state</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Mindfulness integrated cognitive behavioral therapy (MICBT) in 8 sessions based on Cayon protocol.</i_keyword>
      <i_keyword>Intervention group: Group Schema Consulting Group in 12 sessions based on the Yang Protocol (2003)</i_keyword>
      <i_keyword>Control group: no treatment has been applied</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional states that include depression, anxiety and stress are measured by the scale of depression, anxiety and stress (DASS-21). And they can be mild, moderate, and severe. Timepoint: The emotional states were measured once before the intervention in the first session (pre-test) and one time at the end of the intervention in the final session (post-test). Method of measurement: The DASS-21 scale was used to measure emotional states, which has 21 questions with Likert scale and has a good validity and reliability.</prim_outcome>
      <prim_outcome>Quality of life of MS patients measured by MS-QOL scale. And the 3 overall scales includes physical health, health and quality of life. Timepoint: The Quality of life was measured once before the intervention in the first session (pre-test) and one time at the end of the intervention in the final session (post-test). Method of measurement: The quality of life of MS patients was measured by MS-QOL scale, which is specific to assessing the quality of life of these patients. This scale has 54 questions for assessing 14 areas related to physical health and mental health, and its validity and reliability are confirmed by studies.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-05</approval_date>
        <contact_name>Ethics committee, Department of Psychology, Shahid-Bahonar University, Kerman</contact_name>
        <contact_address>Literature and Human Science department, Shahid Bahonar university, Research Square, Imam Khomeini highway Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
