<?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>IRCT20260605069653N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of Self-Compassion Training on Mental Health in Women with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effectiveness of self-compassion therapy on perceived stress, self-differentiation, and functional flexibility in women with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90664</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The statistical population of this study includes all women with multiple sclerosis who have been given a definitive diagnosis of multiple sclerosis by a specialist physician and psychotherapist in a clinical interview and who will refer to the MS Association during the study period. In the sample selection stage, convenience sampling method will be used. After selecting a sample of 40 people based on the study's entry and exit criteria, participants will be randomly assigned to two groups: "self-compassion therapy training" (intervention group) and "waiting list" (control group). Randomization will be performed using the random block method with variable sizes (4 and 6 people) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and numbered envelopes so that the researcher and participants are not aware of the allocation sequence (allocation concealment). Opening the envelope and informing the group allocation will only be done when each participant enters the study. To ensure the equality of the baseline variables (such as anxiety level, age), their distribution in the two groups will be examined during the statistical analysis stage.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Self-compassion therapy; Duration: 90 minutes; Number of sessions: 8 sessions; Sequence of sessions: twice a week; Tools: Body-focused mindfulness, compassionate imagery, thought-distancing techniques (for resilience), and emotional boundary exercises (for self-differentiation). Session summary: Session 1: Pre-test; Introduction to the concepts of compassion and its connection with acceptance of MS disease conditions. Session 2: Recognition of the "inner critic" and its effect on perceived stress; Separation of one's feelings from the psychological burden caused by the disease. Session 3: Mindfulness training for managing physical pain; Practice soothing breathing to reduce stress responses of the nervous system. Session 4: Strengthening self-differentiation; Learning to have an "observing self" against the psychological pressures of the environment and others. Session 5: Promoting functional flexibility; Using the compassionate letter writing technique to change the response from "avoidance" to "active acceptance". Session 6: Examining barriers and fears to self-compassion; confronting emotions such as grief or anger regarding physical changes. Session 7: Practicing compassionate imagery to rebuild a compassionate view of the "body"; establishing coping strategies for dealing with stressors of illness. Session 8: Integration; focusing on maintaining autonomy and healthy boundaries (differentiation); implementing a post-test and follow-up plan. Intervention 2: Control group: The control group will not receive any intervention during the research, but to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization, they will receive a self-compassion therapy intervention after data collection.</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 Due to the lack of completion of the research work and the lack of writing the article, which is a requirement for publishing the data, I will publish the data as soon as the aforementioned issues are resolved.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Savari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 28, Jouibar 2 Street, behind the gas station, Pardis</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6139715614</zip>
        <telephone>+98 61 3333 3333</telephone>
        <email>asasdhddhjn@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Savari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 28, Jouibar 2 Street, behind the gas station, Pardis</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6139715614</zip>
        <telephone>+98 61 3333 3333</telephone>
        <email>asasdhddhjn@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women between the ages of 20 and 40 years
Definitive diagnosis of MS by a clinical specialist</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to participate in research
Participating in other psychotherapy sessions at the same time as the research</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>Intervention group: Self-compassion therapy; Duration: 90 minutes; Number of sessions: 8 sessions; Sequence of sessions: twice a week; Tools: Body-focused mindfulness, compassionate imagery, thought-distancing techniques (for resilience), and emotional boundary exercises (for self-differentiation). Session summary: Session 1: Pre-test; Introduction to the concepts of compassion and its connection with acceptance of MS disease conditions. Session 2: Recognition of the "inner critic" and its effect on perceived stress; Separation of one's feelings from the psychological burden caused by the disease. Session 3: Mindfulness training for managing physical pain; Practice soothing breathing to reduce stress responses of the nervous system. Session 4: Strengthening self-differentiation; Learning to have an "observing self" against the psychological pressures of the environment and others. Session 5: Promoting functional flexibility; Using the compassionate letter writing technique to change the response from "avoidance" to "active acceptance". Session 6: Examining barriers and fears to self-compassion; confronting emotions such as grief or anger regarding physical changes. Session 7: Practicing compassionate imagery to rebuild a compassionate view of the "body"; establishing coping strategies for dealing with stressors of illness. Session 8: Integration; focusing on maintaining autonomy and healthy boundaries (differentiation); implementing a post-test and follow-up plan.</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention during the research, but to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization, they will receive a self-compassion therapy intervention after data collection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived Stress. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The method of measurement will be the Cohen et al. (1983) Perceived Stress Questionnaire.</prim_outcome>
      <prim_outcome>Self-Differentiation. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The measurement method will be the Skowron and Friedlander (1998) differentiation questionnaire.</prim_outcome>
      <prim_outcome>Functional Flexibility. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The measurement method will be using the Connor and Davidson (2003) Functional Flexibility Questionnaire.</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>2026-05-26</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Ahvaz Branch</contact_name>
        <contact_address>Opposite Keshavarz Street, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
