<?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>IRCT20260927071205N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Schema Therapy on Quality of Life and Psychological Well-being in Women with MS</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Schema Therapy on Quality of Life and Psychological Well-being in Women with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93673</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After determining the sample size, 30 participants will be randomly allocated, using simple random assignment by lottery, into two equal groups of experimental and control (15 participants each).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group receive "Group Schema Therapy" based on Young's standard protocol for MS patients. The program consists of 15 weekly 90-minute sessions (total of 15 weeks) as follows:​Phase 1: Assessment and Psychoeducation (Sessions 1–4)​Objectives: Identifying Early Maladaptive Schemas (e.g., Defectiveness, Dependence, Self-Sacrifice) and developing an understanding of the relationship between schemas and disease experiences.​Activities:​Session 1: Introduction to therapy and group principles, completion of the YSQ-S3 questionnaire, reviewing the patient's life history and its connection to schemas.​Session 2: Analysis of schemas activated by the illness (e.g., "I am worthless" due to physical disability), psychoeducation on the concept of "Schema Modes" (Vulnerable Child, Punitive Parent).​Sessions 3 &amp; 4: Utilization of the "Historical Imagery" technique to explore the roots of schemas (e.g., childhood rejection experiences).​Phase 2: Schema Change and Cognitive Restructuring (Sessions 5–10)​Objectives: Weakening maladaptive schemas and strengthening the "Healthy Adult" mode.​Activities:​Session 5: Schema dialogue: Dialoguing with the "Defectiveness" schema as a separate entity.​Session 6: "Letter Therapy" exercise: Writing letters to schemas from the perspective of the Healthy Adult.​Sessions 7 &amp; 8: Cognitive restructuring using belief challenge worksheets (e.g., replacing "I am a burden to others" with "I am valuable despite my limitations").​Sessions 9 &amp; 10: "Limited Emotional Catharsis" technique to reduce anger toward the body.​Phase 3: Reinforcing Adaptive Behaviors and Relapse Prevention (Sessions 11–15)​Objectives: Replacing maladaptive behavioral patterns with healthy behaviors.​Activities:​Session 11: Designing a "Behavioral Plan" to reduce excessive self-sacrifice (e.g., saying no to unreasonable requests from others).​Session 12: Role-playing to practice constructive social interactions.​Sessions 13 &amp; 14: Chair technique practice for schema modes: Dialogue between the "Vulnerable Child" and the "Healthy Adult".​Session 15: Reviewing achievements, formulating a long-term self-care plan, and final assessment (Young, 2023). Intervention 2: Control group: Control group: Participants in this group receive no psychological intervention during the study period and are placed on a waiting list. For ethical considerations, after the completion of the study, post-test, and follow-up assessments, an abbreviated course of Schema Therapy will be offered to the control group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is To protect participants' confidentiality, and in accordance with the informed consent, which permits the use of data only for the purposes of this study, there is no plan to share individual participant data. Results will be reported at the group level.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojtaba Rahnamazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 40, Fajr 11, Noor Street</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4616915686</zip>
        <telephone>+98 11 4427 1329</telephone>
        <email>mojtaba.rahnama@iau.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mojtaba Rahnamazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 40, Fajr 11, Noor Street</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4616915686</zip>
        <telephone>+98 11 4427 1329</telephone>
        <email>mojtaba.rahnama@iau.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmed diagnosis of multiple sclerosis by a specialist physician
Age between 20 and 60 years
Informed consent to participate
At least a high school education
Receiving pharmacological treatment for MS
Not receiving concurrent psychotherapy</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Acute or chronic psychiatric disorder
Absence from more than two treatment 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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in this group receive "Group Schema Therapy" based on Young's standard protocol for MS patients. The program consists of 15 weekly 90-minute sessions (total of 15 weeks) as follows:​Phase 1: Assessment and Psychoeducation (Sessions 1–4)​Objectives: Identifying Early Maladaptive Schemas (e.g., Defectiveness, Dependence, Self-Sacrifice) and developing an understanding of the relationship between schemas and disease experiences.​Activities:​Session 1: Introduction to therapy and group principles, completion of the YSQ-S3 questionnaire, reviewing the patient's life history and its connection to schemas.​Session 2: Analysis of schemas activated by the illness (e.g., "I am worthless" due to physical disability), psychoeducation on the concept of "Schema Modes" (Vulnerable Child, Punitive Parent).​Sessions 3 &amp; 4: Utilization of the "Historical Imagery" technique to explore the roots of schemas (e.g., childhood rejection experiences).​Phase 2: Schema Change and Cognitive Restructuring (Sessions 5–10)​Objectives: Weakening maladaptive schemas and strengthening the "Healthy Adult" mode.​Activities:​Session 5: Schema dialogue: Dialoguing with the "Defectiveness" schema as a separate entity.​Session 6: "Letter Therapy" exercise: Writing letters to schemas from the perspective of the Healthy Adult.​Sessions 7 &amp; 8: Cognitive restructuring using belief challenge worksheets (e.g., replacing "I am a burden to others" with "I am valuable despite my limitations").​Sessions 9 &amp; 10: "Limited Emotional Catharsis" technique to reduce anger toward the body.​Phase 3: Reinforcing Adaptive Behaviors and Relapse Prevention (Sessions 11–15)​Objectives: Replacing maladaptive behavioral patterns with healthy behaviors.​Activities:​Session 11: Designing a "Behavioral Plan" to reduce excessive self-sacrifice (e.g., saying no to unreasonable requests from others).​Session 12: Role-playing to practice constructive social interactions.​Sessions 13 &amp; 14: Chair technique practice for schema modes: Dialogue between the "Vulnerable Child" and the "Healthy Adult".​Session 15: Reviewing achievements, formulating a long-term self-care plan, and final assessment (Young, 2023).</i_keyword>
      <i_keyword>Control group: Control group: Participants in this group receive no psychological intervention during the study period and are placed on a waiting list. For ethical considerations, after the completion of the study, post-test, and follow-up assessments, an abbreviated course of Schema Therapy will be offered to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life (measured with the Multiple Sclerosis Quality of Life Questionnaire, MSQOL-54) and psychological well-being (measured with the 18-item short form of the Ryff Psychological Well-Being Scale) will be assessed at pretest, posttest, and follow-up. Timepoint: Pretest (before the intervention), posttest (immediately after the 15th session), and follow-up (two months after the end of the intervention). Method of measurement: uality of life using the Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire, and psychological well-being using the 18-item short form of Ryff's Psychological Well-Being 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>2025-09-02</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University, Ayatollah Amoli Branch</contact_name>
        <contact_address>No. 40, Fajr 11, Noor Street Amol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
