<?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>IRCT20171217037917N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-30</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of NLP Individual Psychotherapy On The Reduction Of Symptom Of Depression, Anxiety, Stress and Improving Quality of Life and Control of proceeding Disease on RRMS Patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of effectiveness of Neuro Linguistic Programming individual treatment on depression, anxiety, stress, quality of life and the course and severity of the disease in patients with relapsing-remitting multiple-sclerosis (RRMS): a Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28711</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization: After announcement and filling the demographic forms, considering the include and exclude criteria and initial scores in Depression, Anxiety, Stress, Quality of Life and Course of the MS Disease, a total of 60 patients were selected according to a randomized table. Based on the random number table, 30 subjects were divided into two groups: 30 for control and 30 for test.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Multiple sclerosis. Condition 2: Anxiety. Condition 3: Depression. Condition 4: Stress.</hc_freetext>
      <i_freetext>Intervention 1: Experimental or intervention group: 30 patients, One hour individual therapy sessions, intervention: Neuro Linguistic Programming Therapy, 45 sessions: first 16 sessions are weekly, 18 sessions are twice a month and 11 sessions are monthly basis. The therapist's team consists of two masters of Neuro Linguistic Programming, evaluator team who examine the initial implications consist of a psychologist and a psychiatrist and a neurologist. Intervention 2: Control group:  30 patients, without any intervention and with routine care, evaluator team who examine the initial implications consist of a psychologist and a psychiatrist and a neurologist (MS fellowship).</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 due to ethics codes for psychotherapists and counselors</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahare Pourkiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1, Bahar Ave., Ozgol</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1316743896</zip>
        <telephone>+98 21 2219 0588</telephone>
        <email>bahare.pourkiani@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Kasiri Mahouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no. 39, Nategh Ave., Pounak,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1316743896</zip>
        <telephone>+98 21 4461 1923</telephone>
        <email>fatemeh_kassiri@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of MS based on McDonald  criteria by neurologist
Type of MS (relapsing-remitting)
Age range (20 to 40) years old
Residing in Tehran
Having the consent and commitment to attend the course of treatment
Diagnosis of stress, anxiety and depression on DSM criteria by psychiatrist
using of first-line drugs for the MS treatment: Interferons</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnancy or planning for pregnancy
having any type of psychotherapy session during this research
having history of Hospitalization due to psychiatric disorders
diagnosis of other psychiatric disorders according to DSM by a psychiatrist
having cancer
having diabetes
Other diseases of the nervous system other than multiple sclerosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental or intervention group: 30 patients, One hour individual therapy sessions, intervention: Neuro Linguistic Programming Therapy, 45 sessions: first 16 sessions are weekly, 18 sessions are twice a month and 11 sessions are monthly basis. The therapist's team consists of two masters of Neuro Linguistic Programming, evaluator team who examine the initial implications consist of a psychologist and a psychiatrist and a neurologist.</i_keyword>
      <i_keyword>Control group:  30 patients, without any intervention and with routine care, evaluator team who examine the initial implications consist of a psychologist and a psychiatrist and a neurologist (MS fellowship)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of stress. Timepoint: pre test and 6,12,18 months after start of treatment, and 24 months after first intervention as post test. Method of measurement: DASS Questionnaire (Depression, Anxiety, Stress).</prim_outcome>
      <prim_outcome>Level of anxiety. Timepoint: pre test and 6,12,18 months after start of treatment, and 24 months after first intervention as post testT. Method of measurement: DASS Questionnaire (Depression, Anxiety, Stress).</prim_outcome>
      <prim_outcome>Level of depression. Timepoint: pre test and 6,12,18 months after start of treatment, and 24 months after first intervention as post test. Method of measurement: DASS Questionnaire (Depression, Anxiety, Stress).</prim_outcome>
      <prim_outcome>Disability Status. Timepoint: pre test and 6,12,18 months after start of treatment, and 24 months after first intervention as post test. Method of measurement: Kurtzke Expanded Disability Status Scale (EDSS).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: pre test and 6,12,18 months after start of treatment, and 24 months after first intervention as post test. Method of measurement: Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire.</prim_outcome>
      <prim_outcome>Course of MS disease. Timepoint: pre test and 6,12,18 months after start of treatment, and 24 months after first intervention as post test. Method of measurement: MRI (Magnetic Resonance Imaging).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-30</approval_date>
        <contact_name>Ethics in research committee of medicine school of Tehran University of Medical Sciences</contact_name>
        <contact_address>16th Azar St., Enghelab Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
