<?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>IRCT20250529065966N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-26</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of cognitive behavioral group therapy on early maladaptive schemas, functional flexibility, distress tolerance, and self-differentiation in women.</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effectiveness of cognitive behavioral group therapy on early maladaptive schemas, functional flexibility, distress tolerance, and self-differentiation of women undergoing drug treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84437</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Blinding description: 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 in the control group or demoralization, they will be assured that they will receive problem-solving skills training in the next round (after data collection).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Type of intervention: In addition to receiving standard medication for multiple sclerosis (as prescribed by a specialist), this group participates in 12 sessions of cognitive-behavioral group therapy (CBT). Sessions are held weekly, each session lasting 90 minutes, at the counseling center. The intervention includes identifying and modifying early maladaptive schemas, training in functional flexibility, distress tolerance, and self-differentiation skills. Sessions are conducted by an experienced clinical psychologist trained in cognitive-behavioral therapy in groups (6 to 10 people per group). Intervention 2: Control group: The comparison group includes women undergoing drug treatment for multiple sclerosis in Ahvaz who receive the intervention (receiving standard drug treatment and not receiving cognitive behavioral group therapy). Also, there will be no intervention for the control group. However, to prevent threats to the internal validity of the test, the intervention will be implemented for them after the end of the study. After completing the training period, both the experimental and control groups (40 people) will be re-assessed by questionnaires that measure the dependent variables (early maladaptive schemas, functional flexibility, distress tolerance, self-differentiation) as a post-test, and finally, after one month of the post-test, both groups will be re-assessed.</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 Ethics Committee of Islamic Azad University, Ahvaz Branch</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sasan Bavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 61 3332 9200</telephone>
        <email>sasanbavi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sasan Bavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Ahvaz Branch، Farhangshahr، Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 61 3332 9200</telephone>
        <email>sasanbavi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 20 to 40 years for women with MS
Definitive diagnosis of MS by a specialist doctor
Signing a written consent form to participate in the research and adhere to treatment
Minimum education: Diploma</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Attending other psychotherapy sessions at least one month before the study
Substance use and lack of psychotic symptoms and a history of brain diseases such as brain tumors</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>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Type of intervention: In addition to receiving standard medication for multiple sclerosis (as prescribed by a specialist), this group participates in 12 sessions of cognitive-behavioral group therapy (CBT). Sessions are held weekly, each session lasting 90 minutes, at the counseling center. The intervention includes identifying and modifying early maladaptive schemas, training in functional flexibility, distress tolerance, and self-differentiation skills. Sessions are conducted by an experienced clinical psychologist trained in cognitive-behavioral therapy in groups (6 to 10 people per group).</i_keyword>
      <i_keyword>Control group: The comparison group includes women undergoing drug treatment for multiple sclerosis in Ahvaz who receive the intervention (receiving standard drug treatment and not receiving cognitive behavioral group therapy). Also, there will be no intervention for the control group. However, to prevent threats to the internal validity of the test, the intervention will be implemented for them after the end of the study. After completing the training period, both the experimental and control groups (40 people) will be re-assessed by questionnaires that measure the dependent variables (early maladaptive schemas, functional flexibility, distress tolerance, self-differentiation) as a post-test, and finally, after one month of the post-test, both groups will be re-assessed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Early maladaptive schemas: Deep, dysfunctional thought patterns and beliefs that are formed early in life and can cause psychological problems. Timepoint: At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention. Method of measurement: Young's Early Maladaptive Schemas Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional flexibility: A person's ability to adapt their behaviors and attitudes to different situations and changing circumstances. Timepoint: At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention. Method of measurement: Functional Flexibility Questionnaire: Connor and Davidson (2003).</sec_outcome>
      <sec_outcome>At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention. Timepoint: At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention. Method of measurement: Distress Tolerance Questionnaire: Simmons and Gahr (2005).</sec_outcome>
      <sec_outcome>Self-differentiation: The ability of an individual to maintain their identity and independence in close relationships, without losing connection and intimacy. Timepoint: At the beginning of the study (before the intervention) and after about a month and a half of receiving the cognitive behavioral therapy intervention. Method of measurement: Skowron and Friedlander Differentiation Questionnaire:.</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>2024-12-24</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Ahvaz Branch</contact_name>
        <contact_address>Golestan Highway - Farhang City - Islamic Azad University, Ahvaz Unit AHWAZ Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
