<?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>IRCT20231112060034N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-04</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effect of acceptance and commitment-based therapy and compassion-focused therapy on multiple sclerosis patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of acceptance and commitment-based therapy and compassion-focused therapy on death anxiety, fear of falling, life expectancy and demoralization symptoms in patients with multiple sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74595</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: Intervention group: For the first experimental group, commitment-based acceptance therapy will be performed in 8 sessions of 60 minutes. The commitment-based acceptance therapy used in this research will be based on the therapeutic protocol of Hayes and Stroshall (2005). Intervention 2: Intervention group: For the second experimental group, treatment focused on compassion will be done in 8 sessions of 60 minutes. The therapy focused on compassion used in this study was determined based on the program of Gilbert (2010). Intervention 3: Control Group: Includes 20 samples who will not get any therapeutic intervention.</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 I haven't decided yet, but after doing the research with the agreement of the university, I will do this</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>AmirAbolfazl Azizpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nagin Building, Golestan Street, Amir Kabir Street, Baghmisheh Town</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5155994599</zip>
        <telephone>+98 41 4423 9382</telephone>
        <email>stu.a.azizpour@iaut.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>AmirAbolfazl Azizpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nagin Building, Golestan Street, Amir Kabir Street, Baghmisheh Town</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5155994599</zip>
        <telephone>+98 41 4423 9382</telephone>
        <email>stu.a.azizpour@iaut.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of MS disease by brain and nerve specialist and referral of medical case to MS Society
Being 20 to 50 years old
At least two years have passed since the illness
Consent to participate in the research
Not having other acute and chronic physical and psychological diseases based on the patient's medical record</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence in two training sessions and non-cooperation
Not doing the tasks specified in the training course</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>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the first experimental group, commitment-based acceptance therapy will be performed in 8 sessions of 60 minutes. The commitment-based acceptance therapy used in this research will be based on the therapeutic protocol of Hayes and Stroshall (2005).</i_keyword>
      <i_keyword>Intervention group: For the second experimental group, treatment focused on compassion will be done in 8 sessions of 60 minutes. The therapy focused on compassion used in this study was determined based on the program of Gilbert (2010).</i_keyword>
      <i_keyword>Control Group: Includes 20 samples who will not get any therapeutic intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score that subjects will get from answering the questions of the death anxiety scale (Templer, 1970). Timepoint: Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period. Method of measurement: Templer Death Anxiety Scale.</prim_outcome>
      <prim_outcome>The score that the subjects will get from the answers to the questions of the short scale of efficiency in falling the international form (Kampen et al., 2008). Timepoint: Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period. Method of measurement: Short scale of efficiency in falling - international form.</prim_outcome>
      <prim_outcome>The score that the subjects will get from the answers to the questions of the depression syndrome questionnaire (Kisan et al., 2004). Timepoint: Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period. Method of measurement: Questionnaire of Kisan's low morale syndrome.</prim_outcome>
      <prim_outcome>The score that subjects will get from answering the questions of Omid Snyder's questionnaire (Snyder, 1991). Timepoint: Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period. Method of measurement: Hope Snyder questionnaire.</prim_outcome>
      <prim_outcome>In the current research, acceptance and commitment based therapy is the training of skills based on the acceptance and commitment therapy protocol (Hayes and Stroshall, 2005), and it will be carried out during 8 sessions of 60 minutes. Timepoint: Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period. Method of measurement: Treatment protocol based on acceptance and commitment.</prim_outcome>
      <prim_outcome>In the present research, the treatment focused on compassion is the training of skills based on the program of Gilbert (2010) and will be carried out during 8 sessions of 60 minutes. Timepoint: Pre-test and post-test before and after ACT, CFT intervention and after the follow-up period. Method of measurement: Compassion-focused therapy.</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>Islamic Azad university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-08</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad university-Tabriz Branch</contact_name>
        <contact_address>Nagin Building, Golestan Street, Amir Kabir Street, Baghmisheh Town Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
