<?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>IRCT20180206038644N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-14</date_registration>
      <primary_sponsor>Islamic Azad University Of Khorasgan</primary_sponsor>
      <public_title>Compare the effectiveness of two psychological treatment methods on the symptoms of MS patients</public_title>
      <acronym></acronym>
      <scientific_title>Compare the effectiveness of ACT (Acceptance and Commitment Therapy)  and Mindfulness Based Cognitive - Behavioral Stress Management on the coping with stress, physical symptoms and psychological well being in patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29569</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Purposeful random sampling method
Individual random unit
Randomization tool:random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis (MS).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:   The first intervention is Mindfulness based cognitive- Behavioral stress management, The statistical population of the study consisted of all women with MS in Mazandaran  and the sample group included 60 people who were randomly divided into three groups (Mindfulness based cognitive-Behavioral intervention group, Acceptance and Commitment therapy and control group), each one with 20 patients .The patients of experimental group were under Mindfulness Based cognitive - Behavioral Stress therapy.They recieved 8 sessions of therapy every week and each session lasted120 minutes .The purpose of this treatment is to help the authorities to achieve a more valuable life through increased psychological flexibility. Intervention 2: Intervention group: The second intervention is ACT Therapy ( Acceptance and Commitment therapy), The statistical population of the study consisted of all women with MS in Mazandaran  and the sample group included 60 people who were randomly divided into three groups (Mindfulness Integrated Behavior-Cognitive therapy groups, Acceptance and Commitment therapy and control group), each one with 20 patients .The patients of experimental group were under Acceptance and Commitment Therapy .They recieved 8 sessions of therapy every week and each session lasted120 minutes .In this type of treatment instead of changing cognitive, it attemps to increase the psychological relationship of an individual with his thoughts and feelings. Intervention 3: Control group: There are  no intervention such as ( Acceptance and Commitment Therapy and  Mindfulness Based Cognitive - Behavioral  stress Management )during the study.</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 do not have comprehensive information on how to share data with other researchers, I also need mire studying the benefits of sharing data.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Montazeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Termeh Buigding., Valiasr 1 Ave., Amirmazandarani Blvd</address>
        <city>Babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741637095</zip>
        <telephone>+98 11 3525 9911</telephone>
        <email>psychologist_68@yahoo.com</email>
        <affiliation>Islamic Azad University of Khorasgan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sahar Montazeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Termeh Building., Valiasr 1 ave., Amirmazandarani Blvd</address>
        <city>Babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741637095</zip>
        <telephone>+98 11 3525 9911</telephone>
        <email>psychologist_68@yahoo.com</email>
        <affiliation>Islamic Azad University of Khorasgan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not having motion impairment
Not having chronic disease
Not having mental illness
Having a high school diploma
Age range 20 to 40 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:   The first intervention is Mindfulness based cognitive- Behavioral stress management, The statistical population of the study consisted of all women with MS in Mazandaran  and the sample group included 60 people who were randomly divided into three groups (Mindfulness based cognitive-Behavioral intervention group, Acceptance and Commitment therapy and control group), each one with 20 patients .The patients of experimental group were under Mindfulness Based cognitive - Behavioral Stress therapy.They recieved 8 sessions of therapy every week and each session lasted120 minutes .The purpose of this treatment is to help the authorities to achieve a more valuable life through increased psychological flexibility.</i_keyword>
      <i_keyword>Intervention group: The second intervention is ACT Therapy ( Acceptance and Commitment therapy), The statistical population of the study consisted of all women with MS in Mazandaran  and the sample group included 60 people who were randomly divided into three groups (Mindfulness Integrated Behavior-Cognitive therapy groups, Acceptance and Commitment therapy and control group), each one with 20 patients .The patients of experimental group were under Acceptance and Commitment Therapy .They recieved 8 sessions of therapy every week and each session lasted120 minutes .In this type of treatment instead of changing cognitive, it attemps to increase the psychological relationship of an individual with his thoughts and feelings.</i_keyword>
      <i_keyword>Control group: There are  no intervention such as ( Acceptance and Commitment Therapy and  Mindfulness Based Cognitive - Behavioral  stress Management )during the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coping styles with stress score in Andler &amp; Parker questionnaire,Physical symptoms score in Thirty-Six questionnaire Quality of Life, Psychological well being score in Ryff questionnaaire. Timepoint: Measurment of coping styles with stress, Physical symptoms and Psychological well being at the begining of the study (before the intervention begins) and two months after intervention and follow up 3 moths after the end of the intervention. Method of measurement: Andler &amp; Parker coping styles with stress questionnaire, Thirty-Six question Quality of Life questionnaire,  Ryff psychological well being questionnaaire.</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>Islamic Azad University Of Khorasgan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-08</approval_date>
        <contact_name>Reasearch Ethics Committe of  Chalus</contact_name>
        <contact_address>Islamic Azad University of Chalus ,17th Shahrivar Blvd Chalus Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
