<?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>IRCT20201009048974N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-06</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of group therapy based on improving the quality of life in patients with MS</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of group therapy based on improving the quality of life on the meaning of life, self-compassion, emotional self-regulation and quality of life of MS patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66036</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be simple randomization. The randomization unit is individual. Through the table of random numbers, which are produced without any particular pattern and order and are completely random and are made into a table, the names of the participants will be collected as a set of numbers and the numbers will be used to categorize different groups.
Even numbers are in the intervention group and odd numbers are in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Eight one-hour sessions of group therapy based on improving the quality of life will be held based on the theory of Michael Frisch, which is presented in the book Therapy Based on Improving the Quality of Life. In the first session, establishing communication, explaining topics related to the theory of improving the quality of life and treatment goals are discussed and a pre-test is taken. In the second session, defining the treatment based on improving the quality of life, introducing the dimensions of the quality of life, and discovering the problematic cases are done. The third session is taught to change the attitude of the quality of life through changing the attitude towards the situation, correcting any kind of distortion or negativity in thinking. In the fourth session, changing goals and criteria for learning and adopting realistic and flexible goals are taught. In the fifth session, strategies including re-prioritization evaluation and emphasis on very important and controllable areas are reviewed. In the sixth session, the last strategy is taught to strengthen the increase of self-satisfaction in another area that was not paid attention to before. The seventh session of training on the three pillars of treatment based on quality of life (inner richness, quality of time and finding meaning) will be conducted. In the eighth session, summation and post-test will be done. Intervention 2: Control group: no treatment.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Bakhtiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>dr.m.bakhtiari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marziye Feizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 3203 1548</telephone>
        <email>m.feizi8491@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering from multiple sclerosis
Expanded Disability Status Scale (EDSS) should be between 0 and 6
In case of taking psychiatric drugs for depression or anxiety, at least three months have passed since the drug became stable
At least six months have passed since receiving the diagnosis of MS
In the PANAS questionnaire, the positive emotion score should be at least 25 and the negative emotion score should be at least 35
Willingness to participate in research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to complete the informed consent form
Thinking about self-harm or suicide
participating in psychological interventions during the last year</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Eight one-hour sessions of group therapy based on improving the quality of life will be held based on the theory of Michael Frisch, which is presented in the book Therapy Based on Improving the Quality of Life. In the first session, establishing communication, explaining topics related to the theory of improving the quality of life and treatment goals are discussed and a pre-test is taken. In the second session, defining the treatment based on improving the quality of life, introducing the dimensions of the quality of life, and discovering the problematic cases are done. The third session is taught to change the attitude of the quality of life through changing the attitude towards the situation, correcting any kind of distortion or negativity in thinking. In the fourth session, changing goals and criteria for learning and adopting realistic and flexible goals are taught. In the fifth session, strategies including re-prioritization evaluation and emphasis on very important and controllable areas are reviewed. In the sixth session, the last strategy is taught to strengthen the increase of self-satisfaction in another area that was not paid attention to before. The seventh session of training on the three pillars of treatment based on quality of life (inner richness, quality of time and finding meaning) will be conducted. In the eighth session, summation and post-test will be done.</i_keyword>
      <i_keyword>Control group: no treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The meaning of life score in Steger et al.'s questionnaire (MLQ). Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention and three months after the end of the intervention. Method of measurement: Questionnaire of the meaning of life Stegar et al.</prim_outcome>
      <prim_outcome>The Self-Compassion score in the Neff questionnaire (SCS). Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention and three months after the end of the intervention. Method of measurement: Scale of Self-Compassion Neff (SCS).</prim_outcome>
      <prim_outcome>Emotional self-regulation score in Hoffman et al.'s questionnaire (2010). Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention and three months after the end of the intervention. Method of measurement: questionnaire of emotional self-regulation Hoffman et al.'s.</prim_outcome>
      <prim_outcome>The quality of life score in the quality of life questionnaire for patients with multiple sclerosis (MS) made by Vickery (MSQOL-54). Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention and three months after the end of the intervention. Method of measurement: Vickery quality of life questionnaire for patients with multiple sclerosis (MS) (MSQOL-54).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-06</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
