<?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>IRCT20210808052113N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-17</date_registration>
      <primary_sponsor>Deputy of Research, University of Isfahan</primary_sponsor>
      <public_title>Comparison of therapeutic effectiveness based on the analysis of lived experiences of social stigma with positive psychotherapy method in mental toighness, cognitive flexibility, distress tolerance and feeling of entrapment in patients with multiple sclerosis.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of therapeutic effectiveness based on the analysis of lived experiences of social stigma with positive psychotherapy method in mental toighness, cognitive flexibility, distress tolerance and feeling of entrapment in patients with multiple sclerosis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58174</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: The method of intervention is phenomenology of lived experiences in the field of qualitative research. The contents of the treatment session based on the stigmatized life experiences of MS patients to explain and effectiveness of treatment, after the information was done through in-depth interviews with patients and interpretation of data by Colaizzi method, analysis and coding and categorization during data collection and Data collection and analysis continued until theoretical saturation within the scope of the research. Then, the extracted factors were presented and developed to develop a treatment model based on the analysis of lived experiences of stigma. It was held in eight one-and-a-half hour sessions during a week. Intervention 2: Content of Positive Psychotherapy Sessions has been done in eight consecutive sessions. The sessions included recording a positive self-introduction on a page and directing clients in a positive psychotherapy framework, recording each person's ability by themselves, mentioning blessings and repeating tasks which is adapted from Seligman(2006). In the review session, whether writing these three good things or three blessings and emphasizing positive memories and recollections over the past week has had a positive effect or not, using the worksheet related to gratitude, reviewing the relation of treatment of clients with their progress in writing booklets and letters of forgiveness and gratitude and using their capabilities in practice based on their activity plans which began in the second session were examined.Focusing on the topics of hope, faith and optimism, using the art of improving relationships and creating positive social relationships and happiness in life, teaching response style and training to improve relationships and completing questionnaires by participants in eight sessions of one and a half hours per week were done. Intervention 3: Control group:  includes 15 people who are in the waiting list group and do not receive therapy at the time of intervention.But at the end of the therapy, for the sake of ethics, the control group can also use positive psychotherapy and lived-experience therapy if needed.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The group data is related to the main messages of the interview without mentioning the demographic characteristics of the buyers

When:
Five months after printing

To whom:
Academic researchers after authentication

Conditions:
Request to use the data is permitted only for use in cross-cultural studies, multiple sclerosis treatment centers, or meta-combination and meta-analytic studies.

Where to obtain:
send a request to email address yaghoob.harooni2014@gmail.com

How to obtain:
Data information will be provided to individuals via email or WhatsApp after evaluating the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yaghoob Harooni Jamalooei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah blvd.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>009831379331</telephone>
        <email>y.harooni@edu.ui.ac.ir</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yaghoob Harooni Jamalooei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah blvd.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3793 2128</telephone>
        <email>y.harooni@edu.ui.ac.ir</email>
        <affiliation>َUniversity of isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of MS by a specialist.
Age range between 18 and 55 years.
Willingness and signing of written consent. Form of consent to participate in the research project.
Not suffering from a severe physical illness, severe neurological disorders, or having symptoms of psychosis.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>relapse of illness and inability to continue sessions
absence of more than two 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>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The method of intervention is phenomenology of lived experiences in the field of qualitative research. The contents of the treatment session based on the stigmatized life experiences of MS patients to explain and effectiveness of treatment, after the information was done through in-depth interviews with patients and interpretation of data by Colaizzi method, analysis and coding and categorization during data collection and Data collection and analysis continued until theoretical saturation within the scope of the research. Then, the extracted factors were presented and developed to develop a treatment model based on the analysis of lived experiences of stigma. It was held in eight one-and-a-half hour sessions during a week.</i_keyword>
      <i_keyword>Content of Positive Psychotherapy Sessions has been done in eight consecutive sessions. The sessions included recording a positive self-introduction on a page and directing clients in a positive psychotherapy framework, recording each person's ability by themselves, mentioning blessings and repeating tasks which is adapted from Seligman(2006). In the review session, whether writing these three good things or three blessings and emphasizing positive memories and recollections over the past week has had a positive effect or not, using the worksheet related to gratitude, reviewing the relation of treatment of clients with their progress in writing booklets and letters of forgiveness and gratitude and using their capabilities in practice based on their activity plans which began in the second session were examined.Focusing on the topics of hope, faith and optimism, using the art of improving relationships and creating positive social relationships and happiness in life, teaching response style and training to improve relationships and completing questionnaires by participants in eight sessions of one and a half hours per week were done.</i_keyword>
      <i_keyword>Control group:  includes 15 people who are in the waiting list group and do not receive therapy at the time of intervention.But at the end of the therapy, for the sake of ethics, the control group can also use positive psychotherapy and lived-experience therapy if needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental toughness. Timepoint: Before and after the therapy. Method of measurement: Mental toughness survey.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive flexibility. Timepoint: Before and after the therapy. Method of measurement: Cognitive flexibility survey(CFI).</sec_outcome>
      <sec_outcome>Mental toughness. Timepoint: Before and after the therapy. Method of measurement: Mental toughness survey(MTQ).</sec_outcome>
      <sec_outcome>Distress tolerance. Timepoint: Before and after the therapy. Method of measurement: Distress tolerance survey(DTF).</sec_outcome>
      <sec_outcome>Feeling entrapment. Timepoint: Before and after the therapy. Method of measurement: feeling entrapment survey(Gilbert and Allen).</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>Deputy of Research, University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-12</approval_date>
        <contact_name>University of Isfahan</contact_name>
        <contact_address>Isfahan university, Daneshgah st Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
