<?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>IRCT20221228056957N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Treatment (AMDR) and Positive Psychotherapy in Depression and Quality of Life in Men and Women with MS.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of (EMDR) and Positive Psychotherapy in Depression and Quality of Life in Men and Women with MS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67669</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The research will include voluntary sampling, wich will be randomly assigned to two experimental groups and one control group. First,the scores in depression and quality of life are determined with the pre-test, then after the implementation of the desired therapeutic intervention, the post-test will be implemented to check their effectiveeness.To calculate the sampel size in the semi -experimental research, the tableprepared by cohen in used (Cohen, 1986), (Dr. Zohra Sarmad et al.). In this research, the significance level is 0/05 and the power of the test is 0/84, in this research, 45 qualified peple are included in the research and they are randomly divided in to three groups of peple, two experimental groups and one control group, Blinding description: participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: The first group consists of 15 participants, which is a treatment method of desensitization with eye movements and reprocessing, which includes 8 sessions:1-taking history, 2-preparation, 3-evaluation, 4-desensitization, 5-installation (replacement), 6 - Body scan, 7- Closure, 8- Re-evaluation. (Shapiro; 2001). Intervention 2: Intervention group: The second group consists of 15 participants, in which positive psychotherapy intervention is performed, positive psychology training sessions based on Seligman, Rashid and Park (2006) protocol, includes 8 sessions:1- Introduction and orientation 2- Personal capabilities and using them in a new way, 3- Cultivating positive emotions and mentioning blessings and things in life, 4- Personal heritage and having a purpose and goal in life, 5- Letters and visits of thanks, 6- Relationships Social positivity and happiness in life, 7- Working with peaceful reflection and avoiding haste, 8- Celebration and happiness and stabilization of happiness. Intervention 3: Control group: the third group which consists of 15 people, no therapeutic intervention is performed in this 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>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 We will decide after the completion of the project.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 25t, 17 Ave, Azadi Blvd, Alvand Town</address>
        <city>Alvand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3973188981</zip>
        <telephone>+98 21 3222 2287</telephone>
        <email>ashoseinii59@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 25, 17 Ave, Azadi blvd, alvand town</address>
        <city>Alvand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3431846445</zip>
        <telephone>+98 28 3222 2287</telephone>
        <email>ashoseinii59@gmail.com</email>
        <affiliation>Qazvin University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering from Multiple Sclerosis
Having at least middle school education to understand the concepts  treatment
Obtaining informed consent to explain the proceess of therapeutic interventionand research
Providing the necessary explanation about the necessity of attending treatment sessions
Having the physical and mental ability to attend the treatment intervention sessions
No receive psychological treatments for at least 6 months before intervention sessions
Having an age rang of 18 to 60 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having less than middle school education
Receiving psychological treatments during 6 months before starting the therapeutic intervention
Being less than 18 or more than 60 years old</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>The first group consists of 15 participants, which is a treatment method of desensitization with eye movements and reprocessing, which includes 8 sessions:1-taking history, 2-preparation, 3-evaluation, 4-desensitization, 5-installation (replacement), 6 - Body scan, 7- Closure, 8- Re-evaluation. (Shapiro; 2001).</i_keyword>
      <i_keyword>Intervention group: The second group consists of 15 participants, in which positive psychotherapy intervention is performed, positive psychology training sessions based on Seligman, Rashid and Park (2006) protocol, includes 8 sessions:1- Introduction and orientation 2- Personal capabilities and using them in a new way, 3- Cultivating positive emotions and mentioning blessings and things in life, 4- Personal heritage and having a purpose and goal in life, 5- Letters and visits of thanks, 6- Relationships Social positivity and happiness in life, 7- Working with peaceful reflection and avoiding haste, 8- Celebration and happiness and stabilization of happiness.</i_keyword>
      <i_keyword>Control group: the third group which consists of 15 people, no therapeutic intervention is performed in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score. Timepoint: Before the intervention, after the intervention and 3 months after the intervention. Method of measurement: Beck questionnaire.</prim_outcome>
      <prim_outcome>Quality of life score. Timepoint: Before the intervention, after the intervention and 3 months after the intervention. Method of measurement: The Beck questionnaire is used to measure depression and the quality of life questionnaire of multiple sclerosis patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety score. Timepoint: Before and after study. Method of measurement: Kattle questionnaire.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-30</approval_date>
        <contact_name>Ethical Committee of Islamic Azad University of Rodehen</contact_name>
        <contact_address>Ayatollah Khamenei Blvd., Islamic Azad University., University complex., Rodehen., Iran rodehen Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
