<?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>IRCT20180421039369N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-10</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The study of the efficacy of the Transdiagnostic Treatment of the Unified for the Improvement of Comorbid Psychological Disorders  in Ms Patients</public_title>
      <acronym></acronym>
      <scientific_title>The study of the efficacy of the Transdiagnostic Treatment of the Unified for the Improvement of Comorbid Psychological Disorders (Depression, Anxiety and Health Anxiety), Fatigue and Quality of Life in Patients with Multiple Sclerosis (Ms)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39402</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomizing assignment, the Simple Random method is used. 45 cards with the same appearance are provided. On 15 of cards the number 1 and on 30 of them the number 2 is written which represent the intervention group and the control group respectively. Then, one card is given to each qualified individual randomly and his assignment to the group is recorded. This process is continues until all individuals are assigned. It should be noted that participants are unaware of the nature of the numbers and type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>comorbidity of Psychological disorders in Patient with MS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In this study, the  Barlow unified protocol for transdiagnostic treatment method will be used.The sample size in this study is 45. They are randomly divided into two experimental and control groups, in which 15 subjects in the experimental group and 30 in the control group are placed and the program The treatment, along with the workbook, will be provided to an individual group for 12 consecutive sessions. The treatment sessions are divided into eight sections: Section 1: Increased motivation for participation in treatment, Section 2: Psychological training and tracking emotional experiences, Section 3: Exercise Excitement Education Section, 4) Assess and modify cognitive assessment, Section 5) Avoid Excitement and Excitement, Section 6) Awareness of physical feelings and tolerance with them, Section 7) Exposure to internal and external triggers of excitement, Section 8) Prevention of recurrence. Intervention 2: Control group:  Control group: consists of 30 people who are waiting in the waiting list and do not receive treatment during the time of intervention. but after treatment, they will receive Transdiagnostic Treatment of the Unified Protocol  for maintaining the ethics of the control group.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sasan amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 84 3442 3968</telephone>
        <email>sasanamiri2910@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>sasan amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 84 3442 3968</telephone>
        <email>sasanamiri2910@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering Ms disease with diagnosis of the neurological department
Having a score of less than 5 in the (EDSS) Disability Indicator based on a neurologist's assessment to determine the individual's ability to attend a therapeutic session
The age range is between 50 to 18 years old
Affliction of emotional coexistence disorders including depression, anxiety and health anxiety based on diagnostic interview by psychologist
Motivation and satisfaction for participation during treatment and research implementation
Failure to receive psychological treatment in the past year
Have at least a cycle of educationNot having other chronic diseases such as severe liver disorder
The lack of current diagnosis of any mental disorder is consistent in Diagram 1 and 2 based on a psychologist's diagnostic interview, with the exception of emotional disorders including depression, anxiety and health anxiety
No obvious risk of suicide now
There is no history of drug abuse or dependence at the current time and within one year before the start of treatment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to attend research meetings
Not attending at least 50% of the sessions
Creating severe physical problems so that it can not be present at meetings</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified mental disorders due to brain damage and dysfunction and to physical disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In this study, the  Barlow unified protocol for transdiagnostic treatment method will be used.The sample size in this study is 45. They are randomly divided into two experimental and control groups, in which 15 subjects in the experimental group and 30 in the control group are placed and the program The treatment, along with the workbook, will be provided to an individual group for 12 consecutive sessions. The treatment sessions are divided into eight sections: Section 1: Increased motivation for participation in treatment, Section 2: Psychological training and tracking emotional experiences, Section 3: Exercise Excitement Education Section, 4) Assess and modify cognitive assessment, Section 5) Avoid Excitement and Excitement, Section 6) Awareness of physical feelings and tolerance with them, Section 7) Exposure to internal and external triggers of excitement, Section 8) Prevention of recurrence</i_keyword>
      <i_keyword>Control group:  Control group: consists of 30 people who are waiting in the waiting list and do not receive treatment during the time of intervention. but after treatment, they will receive Transdiagnostic Treatment of the Unified Protocol  for maintaining the ethics of the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comorbidity of psychological disorders of patients with MS. Timepoint: A week before the intervention, one week after the intervention, Three months after the intervention. Method of measurement: Beck Depression Inventory (BDI-II), Beck Anxiety Inventory, Short form Health Anxiety Scale (SHIA), Fatigue Exercise Scale (FSS), and Quality of Life Scale (MSQOL-54) questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: A week before the intervention, one week after the intervention, three months after the intervention. Method of measurement: Beck Depression Inventory (BDI-II).</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: A week before the intervention, one week after the intervention, three months after the intervention. Method of measurement: Beck Anxiety Inventory.</sec_outcome>
      <sec_outcome>Health Anxiety. Timepoint: A week before the intervention, one week after the intervention, three months after the intervention. Method of measurement: Short Form Health Anxiety Scale (SHIA).</sec_outcome>
      <sec_outcome>Fatigue Severity. Timepoint: A week before the intervention, one week after the intervention, three months after the intervention. Method of measurement: Fatigue Severity Scale (FSS).</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: A week before the intervention, one week after the intervention, three months after the intervention. Method of measurement: Multiple Sclerosis Quality of Life-54 (MSQOL-54).</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-24</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
