<?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>IRCT20180218038786N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-08</date_registration>
      <primary_sponsor>Vice chancellor for research, Hakim Sabzevari University</primary_sponsor>
      <public_title>The Effect of Group Therapy Based on Acceptance and Commitment on  Meaning Life,Distress Tolerance, Pain Self-Efficacy and Quality of Life in Patients whit Multiple Sclerosis (MS)</public_title>
      <acronym></acronym>
      <scientific_title>The Effectivness of Group Therapy Based on Acceptance and Commitment on   Meaning in Life,Distress Tolerance, Pain Self-Efficacy and Quality of Life in Patients whit Multiple Sclerosis (MS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37206</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation method will be simple random. Hiding the assignment using a computer is that the computer creates random numbers between zero and one. If the random number is less than 0/005, the individual will be assigned to the test group, and if the random number is greater than 0/005, the individual will be entered into the control group. In this process, people who enter the study list will not be aware of how the treatment is allocated before the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis (MS).</hc_freetext>
      <i_freetext>Intervention 1: Control group: The control group simultaneously (two-hour sessions for 8 weeks) will continue Center’s usual care plan of the group. Intervention 2: Intervention group: The Intervention group will attend acceptance and commitment group therapy sessions for 8 weeks (8 sessions of two hour). In general, the treatment plan for this group will be to at assess previous session homework, teaching a new technique and giving homework for future session.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No More Information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faezeh Dalalmoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pajohesh Squar</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9319774446</zip>
        <telephone>+98 51 4330 5000</telephone>
        <email>f.dalalmoghadam2016@gmail.com</email>
        <affiliation>The Islamic Azad University of Neyshabour</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Shareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tohid Shahr Street</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617666666</zip>
        <telephone>+98 51 4441 9050</telephone>
        <email>hsharreh@yahoo.com.au</email>
        <affiliation>Hakim Sabzevari University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 20 to 50 years
Having at least a high school diploma
Willingness to participate in the study
being randomly into one of the study groups
Diagnosis of MS by a neurologist</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with any serious psychological disorders (including psychotic disorders or active substance abuse).
Receiving intrudent pharmacological and non pharmacological treatments
Having a neurological disorder other than MS
Education less than fifth elementary</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple Sclerosis (MS)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: The control group simultaneously (two-hour sessions for 8 weeks) will continue Center’s usual care plan of the group</i_keyword>
      <i_keyword>Intervention group: The Intervention group will attend acceptance and commitment group therapy sessions for 8 weeks (8 sessions of two hour). In general, the treatment plan for this group will be to at assess previous session homework, teaching a new technique and giving homework for future session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life Score in Quality of Life Inventory. Timepoint: Measurement of Quality of Life before Intervention and 60 Days after the Onset of Acceptance and Commitment Group Therapy. Method of measurement: The Short Form Quality of Life Inventory.</prim_outcome>
      <prim_outcome>Meaning Life Score in Meaning in Life Question. Timepoint: Measurement of  Meaning Life before Intervention and 60 Days after the Onset of Acceptance and Commitment  Group Therapy. Method of measurement: Meaning in Life Question.</prim_outcome>
      <prim_outcome>Distress Tolerance Score in Distress Tolerance  Scale. Timepoint: Measurement of Distress Tolerance  before Intervention and 60 Days after the Onset of Acceptance and Commitment  Group Therapy. Method of measurement: Distress Tolerance Scale.</prim_outcome>
      <prim_outcome>Pain Self-Efficacy Score in Self Pain Efficacy Inventory. Timepoint: Measurement of Pain Self-Efficacy before Intervention and 60 Days after the Onset of Acceptance and Commitment Group Therapy. Method of measurement: Self Pain Efficacy Inventory.</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>Vice chancellor for research, Hakim Sabzevari University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-13</approval_date>
        <contact_name>Ethic Committee of Hakim Sabzevari University</contact_name>
        <contact_address>Tohid Shahr ,Hakim Sabzevari University Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
