<?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>IRCT20230222057491N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effect of therapy based on acceptance and commitment with a focus on compassion and yoga exercises on MS patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effectiveness of acceptance and commitment therapy with a focus on compassion and yoga exercises on self-management, difficulty in emotion regulation, pain acceptance and pain catastrophizing in multiple sclerosis patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68777</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Available sampling and individual randomization unit. In this study, using non -residential sampling methods available and voluntarily, citing previous research records and valid research books of 45 are selected as statistical samples. In this study we have three groups, people are randomly in each group as I explain below. Group 1 receive admission -based and commitment treatment focusing on compassion, the second group performs yoga exercises, and the third group is a control group that does not receive any treatment. 45 pieces of paper are numbered from number 1 to 45, group one from 1 to 15 and Group two are from 16 to 30 and Group 3 from number 31 to 45. Participants are unaware of what group numbers are. We urge people to draw one of the papers that are unclear, and the number that each person has to show in which group is randomly placed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group includes MS patients who receive treatment based on acceptance and commitment with a focus on compassion. The sessions include one pre-session and ten treatment sessions. It lasts 72 days in total. The pre-meeting is related to getting to know the group members and each other, checking the reasons for participation and expectations, the necessity of psychotherapy, introducing the approach, stating the rules and structure of the meetings, obtaining written consent and performing the pre-test, and the next ten treatment sessions will receive therapeutic intervention. . The first session: performing awareness training (body observation exercise), establishing a therapeutic alliance (metaphor of 2 mountains), expressing control as a performance measurement problem (metaphor of sand pool), introducing emotion regulation systems and assigning homework. It takes a total of 72 days. The second session: reviewing homework, practicing mindfulness, getting to know the old and new brain, introducing the dimensions of compassion and the three competitors of kindness (metaphor of the mother cat), creating creative frustration (metaphor of pressing the work board), training to create a blameless perspective and determine Homework. Third session: 3rd: Reviewing assignments, doing a brief mindfulness practice, creating sensitivity to human suffering in the context of the present, extending conscious mind compassion to the outside world and developing sensitivity to the disturbances of the present, practicing compassionate attention, filling in the daily compassionate worksheet and reviewing experiences and assigning homework. The fourth session: reviewing assignments, practicing compassionate attention, teaching and creating compassionate disruption, applying the metaphor of the freeway of the mind, and practicing the white room in a compassionate context, and assigning homework. Fifth: Homework Review, Compassionate Mindfulness Practice, Compassionate Intention Training, Compassionate Letting Go Metaphor, Ending War Practice Rope, and Homework Assignments. Sixth: Review assignments, practice compassionate attention, provide necessary training about the observer self in a compassionate context with an emphasis on empathy and compassion as a common human sense, the metaphor of the sky and the weather, perform the 2-chair technique for the inner critic and compassionate self, and determine Homework. The seventh session is reviewing homework, practicing mindfulness, teaching and freely choosing compassionate values with an emphasis on health care and the importance of loving relationships, determining life values in a context of compassion in the nine domains (compass of life), magic wand metaphors and Mind reading machine and homework assignments. Eighth session: Reviewing assignments, practicing mindfulness, teaching committed action in line with compassionate values with an emphasis on healing human suffering, children's practice on the bus, setting 4 goals and how to deal with obstacles to action, and setting homework. Ninth session: Reviewing assignments , practicing awareness attention, cultivating a kind mind in the framework of functional contextualism, practicing kind self-imagery, practicing communicating with different aspects of oneself and setting homework. Tenth session: reviewing homework, doing awareness attention practice, reviewing and summarizing the contents, thanks and appreciation and post-test implementation. Intervention 2: Intervention group: This group includes people who have been definitively diagnosed with MS through neurological examinations and magnetic resonance imaging, which have been confirmed by a specialist doctor and  are recorded in the MS register. The members of this group do 24 sessions of yoga exercises. The time interval of the meetings is once every three days and it lasts 72 days in total. Intervention 3: Control group: people in this group do not undergo any psychological treatment or yoga exercises and remain on the waiting list. After the completion of the treatment sessions, at the same time as the other groups, they will be given a pre-test, post-test and follow-up test. are compared. Also, after 60 days, the subjects will answer the questions of the questionnaires again as a follow-up step.</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:
Total data

When:
A few months after the results were published

To whom:
Researchers and all those who read articles

Conditions:
For scientific research

Where to obtain:
For academic and scientific journals

How to obtain:
Online search process

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farhad Jahangiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 21, Shahid Ghane Alley, Takhti Street</address>
        <city>Borujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6915757857</zip>
        <telephone>+98 66 4250 6423</telephone>
        <email>jahangirifarhad3@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farhad Jahangiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 21, Shahid Ghane Alley, Takhti Street</address>
        <city>Borujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6915757857</zip>
        <telephone>+98 66 4250 6423</telephone>
        <email>jahangirifarhad3@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis based on neurological examinations and magnetic resonance imaging by a specialist doctor
Not suffering from other neurological and chronic diseases at the same time
Absence of mild cognitive problems by short mental state test
Absence of severe psychological disorders
Membership in the Multiple Sclerosis Association
Age range from 26 to 44 years
Literacy for reading and writing</inclusion_criteria>
      <agemin>26 years</agemin>
      <agemax>44 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from other neurological and chronic diseases
Suffering from severe psychological disorders at the same time
Having cognitive problems
Taking psychiatric and psychoactive drugs
No membership in the Multiple Sclerosis Association
Age less than 26 and more than 44 years
Lack of literacy</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>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group includes MS patients who receive treatment based on acceptance and commitment with a focus on compassion. The sessions include one pre-session and ten treatment sessions. It lasts 72 days in total. The pre-meeting is related to getting to know the group members and each other, checking the reasons for participation and expectations, the necessity of psychotherapy, introducing the approach, stating the rules and structure of the meetings, obtaining written consent and performing the pre-test, and the next ten treatment sessions will receive therapeutic intervention. . The first session: performing awareness training (body observation exercise), establishing a therapeutic alliance (metaphor of 2 mountains), expressing control as a performance measurement problem (metaphor of sand pool), introducing emotion regulation systems and assigning homework. It takes a total of 72 days. The second session: reviewing homework, practicing mindfulness, getting to know the old and new brain, introducing the dimensions of compassion and the three competitors of kindness (metaphor of the mother cat), creating creative frustration (metaphor of pressing the work board), training to create a blameless perspective and determine Homework. Third session: 3rd: Reviewing assignments, doing a brief mindfulness practice, creating sensitivity to human suffering in the context of the present, extending conscious mind compassion to the outside world and developing sensitivity to the disturbances of the present, practicing compassionate attention, filling in the daily compassionate worksheet and reviewing experiences and assigning homework. The fourth session: reviewing assignments, practicing compassionate attention, teaching and creating compassionate disruption, applying the metaphor of the freeway of the mind, and practicing the white room in a compassionate context, and assigning homework. Fifth: Homework Review, Compassionate Mindfulness Practice, Compassionate Intention Training, Compassionate Letting Go Metaphor, Ending War Practice Rope, and Homework Assignments. Sixth: Review assignments, practice compassionate attention, provide necessary training about the observer self in a compassionate context with an emphasis on empathy and compassion as a common human sense, the metaphor of the sky and the weather, perform the 2-chair technique for the inner critic and compassionate self, and determine Homework. The seventh session is reviewing homework, practicing mindfulness, teaching and freely choosing compassionate values with an emphasis on health care and the importance of loving relationships, determining life values in a context of compassion in the nine domains (compass of life), magic wand metaphors and Mind reading machine and homework assignments. Eighth session: Reviewing assignments, practicing mindfulness, teaching committed action in line with compassionate values with an emphasis on healing human suffering, children's practice on the bus, setting 4 goals and how to deal with obstacles to action, and setting homework. Ninth session: Reviewing assignments , practicing awareness attention, cultivating a kind mind in the framework of functional contextualism, practicing kind self-imagery, practicing communicating with different aspects of oneself and setting homework. Tenth session: reviewing homework, doing awareness attention practice, reviewing and summarizing the contents, thanks and appreciation and post-test implementation.</i_keyword>
      <i_keyword>Intervention group: This group includes people who have been definitively diagnosed with MS through neurological examinations and magnetic resonance imaging, which have been confirmed by a specialist doctor and  are recorded in the MS register. The members of this group do 24 sessions of yoga exercises. The time interval of the meetings is once every three days and it lasts 72 days in total.</i_keyword>
      <i_keyword>Control group: people in this group do not undergo any psychological treatment or yoga exercises and remain on the waiting list. After the completion of the treatment sessions, at the same time as the other groups, they will be given a pre-test, post-test and follow-up test. are compared. Also, after 60 days, the subjects will answer the questions of the questionnaires again as a follow-up step.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-management is a score that the subject receives through the self-management scale of MS patients (revised) by Bishop and Frain (2011). This self-report tool is compiled in 24 items and 5 subscales. The higher the person's score, the higher the level of self-management. The range of changes in this tool is between 24 and 120. Timepoint: At the beginning of the study, that is, before the intervention in the form of a pre-test and after the intervention in the form of a post-test and then in the follow-up. Method of measurement: The Multiple Sclerosis Self-Management Scale–Revised (MSSM-R).</prim_outcome>
      <prim_outcome>Difficulty in emotion regulation is the score that the subject receives through the difficulty of emotion regulation scale by Gratz and Roemer (2004). This self-report tool has 36 items and 6 subscales. Higher scores mean more difficulty in emotional regulation. Timepoint: At the beginning of the study, that is, before the intervention in the form of  a pre-test and after the intervention in the form of a post-test and then in the follow-up. Method of measurement: Difficulties in Emotion Regulation Scale.</prim_outcome>
      <prim_outcome>Acceptance of pain is the score that the subject receives from the Chronic Pain Acceptance Questionnaire - Revised by McCracken et al. (2004). The questionnaire has 20 items and two factors of participation in activity and desire for pain have been identified in this questionnaire. To obtain a total score, we add the scores of each factor together. Higher scores indicate higher levels of acceptance. Timepoint: At the beginning of the study, that is, before the intervention in the form of a pre-test and after the intervention in the form of a post-test and then in the follow-up. Method of measurement: Chronic Pain Acceptance Questionnaire - Revised.</prim_outcome>
      <prim_outcome>Pain catastrophizing is a score that the subject receives through the pain catastrophizing scale of Sullivan et al. (1995). This questionnaire contains 13 statements about the person's thoughts and feelings during past painful experiences, which has subscales of rumination, magnification, and helplessness. . Questions are scored on a 5-point Likert scale, and a higher total score indicates a higher level of catastrophizing thoughts and feelings. Timepoint: At the beginning of the study, that is, before the intervention in the form of  a pre-test and after the intervention in the form of a post-test and then in the follow-up. Method of measurement: Pain Catastrophizing Scale.</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>2023-02-12</approval_date>
        <contact_name>Ethics committee of Borujerd Islamic Azad University of Medical Science</contact_name>
        <contact_address>Imam Khomeini University Complex, Nawab،  3 km Yadgar Imam Road, Nawab Square, Borujerd Borujerd Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
