<?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>IRCT20200616047804N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-16</date_registration>
      <primary_sponsor>Department of Psychology,Islamic Azad University of Ardabil, Ardabil, Iran</primary_sponsor>
      <public_title>The Effectiveness of Reality Therapy &amp; Positive psychotherapy on Emotional Reactions and the Quality of Life and Sleep of Patients with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Reality Therapy &amp; Positive psychotherapy on Emotional Reactions and the Quality of Life and Sleep of Female Patients with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49389</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: About 60 female patients who are members of the MS Association of Guilan Province were introduced to the researcher by the director of the association according to the criteria for admission. After placing the names of the individuals individually in the lottery bag, 45 people in three groups of 15 (two experimental groups and one control group) were randomly removed from the lottery bag by the clinic secretary.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis..</hc_freetext>
      <i_freetext>Intervention 1: In this study, group reality therapy will be used. In this study, 30 female patients who are members of Guilan Province MS Association were randomly selected and were divided to two experimental and control groups. The data collection and then intervention on the experimental group were performed for eight 90-minute sessions during a 2-month period and during this period no intervention will be applied to the control group. Intervention 2: In this study, the method of positive psychotherapy will be used. The number of samples in this study are 30 female patients who are members of the MS Association of Guilan Province are randomly selected and divided into two groups of 15 people for experimental and control one. Data collection and then intervention on the experimental group will be performed for 8 sessions of 90 minutes for 2 months and during this period no intervention will be applied on 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>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 With the consent of the University of Origin (Islamic Azad University, Ardabil Branch), it will be possible to publish.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Hadi Rafiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Square, Islamic Azad University Complex, Ardabil Branch، Ardabil, Iran</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615731567</zip>
        <telephone>+98 45 3372 8029</telephone>
        <email>Hrafiee1363@yahoo.com</email>
        <affiliation>Department of Psychology, Islamic Azad University, Ardabil Branch,  Ardabil, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Hadi Rafiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Square, Islamic Azad University of Ardabil, Ardabil Twon</address>
        <city>Ardebil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5615731567</zip>
        <telephone>+98 45 3372 8029</telephone>
        <email>Hrafiee1363@yahoo.com</email>
        <affiliation>Department of Psychology, Islamic Azad University, Ardabil Branch, Ardabil, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 17 and 55 years old
Reading and writing literacy
Not being in the critical level of the disease
Not being hospitalized due to mental illnesses
Regular participation in therapeutic meetings</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not participating in the therapeutic meetings or using other psychotherapy methods during the research
No drug addiction
Having no hearing or speaking issues
Do not attend a maximum of one-third of the training sessions</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, group reality therapy will be used. In this study, 30 female patients who are members of Guilan Province MS Association were randomly selected and were divided to two experimental and control groups. The data collection and then intervention on the experimental group were performed for eight 90-minute sessions during a 2-month period and during this period no intervention will be applied to the control group.</i_keyword>
      <i_keyword>In this study, the method of positive psychotherapy will be used. The number of samples in this study are 30 female patients who are members of the MS Association of Guilan Province are randomly selected and divided into two groups of 15 people for experimental and control one. Data collection and then intervention on the experimental group will be performed for 8 sessions of 90 minutes for 2 months and during this period no intervention will be applied on the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional reactions. Timepoint: Beginning of study, end of study (eighth week). Method of measurement: depression, anxiety and stress questionnaire (DASS21).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Beginning of study, end of study (eighth week). Method of measurement: MS quality of life scale (MSIS-29).</prim_outcome>
      <prim_outcome>Sleep quality. Timepoint: Beginning of study, end of study (eighth week). Method of measurement: sleep quality questionnaire (PSQI).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Islamic Azad University of Ardabil, Ardabil, Iran</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Department of Psychology, Islamic Azad University, Ardabil Branch, Ardabil, Iran</source_name>
      <source_name>Department of Psychology - Islamic Azad University of Ardabil, Ardabil, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-27</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Head Office of Guilan University of Medical Sciences - Fifth Floor of central office, in front of Azodi Stadium, Namjoo St, Rasht; Contact Number: 33310209- 33329706 - 013 Telegram: 33329706; Email: ravabetomomi@gums.ac.ir Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
