<?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>IRCT20250308064981N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-09</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>DBT for people with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Dialectical Behavior Therapy (DBT) on mood swings, Intolerance of Uncertainty and interpersonal problems in women with Multiple Sclerosis (MS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82296</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Initially, patients interested in participating in the study were examined by a neurologist (with an MS fellowship) and underwent an initial interview with a psychologist (the researcher). Patients meeting the study's inclusion criteria were identified and selected using purposive sampling. During the first meeting, to adhere to ethical guidelines, the researcher provided participants with information regarding the study (number and duration of sessions, session format, etc.), randomization (assignment to experimental or control groups), data confidentiality, and the right to withdraw from the study at any time; informed consent for participation was then obtained. Following the matching of participants based on age and education, assignment to the experimental and control groups was carried out randomly using a table of random numbers. A random number table consists of a large set of numbers generated entirely at random without any discernible pattern or order and arranged in a tabular format. To utilize the table, a method was employed in which even numbers were assigned to the experimental group and odd numbers to the control group. Furthermore, the two groups were matched regarding all known factors and confounding variables.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, the participants will be given a pre-test. The pre-test includes 3 questionnaires to assess and measure dependent variables. Then, the intervention group will receive dialectical behavior therapy for 3 months (12 sessions, one session per week) and finally, they will be given a post-test. Intervention 2: Control group: Participants will first be given a pre-test. They will not receive any psychological treatment and will only receive their usual medication. Then they will be given a post-test.</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:
Demographic information including: age, education, marital status, employment status; duration of illness.
Information related to participants' scores on questionnaires measuring the variables under study.
Data entered into SPSS program

When:
6 months after results are published

To whom:
Researchers working in universities and scientific centers

Conditions:
For research and articles in the fields of psychology, psychiatry, neurology and neuroscience

Where to obtain:
fatemehshams.psy@gmail.com

How to obtain:
Go to the email listed on the site and submit a request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Shamsi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th floor, No. 8, gole sorkh alley, hashemi street, golha town, Eslamshahr, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3315683748</zip>
        <telephone>+98 21 5612 0880</telephone>
        <email>fatemehshams.psy@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Zanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kargarnejad Educational and Therapeutic Medical, 5 km from Qotb Rawandi - end of Parstar Boulevard, kashan  Center,</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715973474</zip>
        <telephone>+98 31 5558 9212</telephone>
        <email>z_zanjani2005@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Received a diagnosis of Multiple Sclerosis (MS) from a neurologist
Gender : Female
Age 20-45 years
Expanded Disability Status Scale (EDSS) score less than 4
Settling in inactive periods of the disease (stable, no relapse, no new lesions on MRI)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from chronic psychological disorders such as depression, anxiety, psychotic disorders, and bipolar disorder.
Suffering from chronic physical conditions such as high blood pressure, diabetes, lung diseases, and heart diseases.
Receiving concurrent psychological treatment
Receiving corticosteroid pulse therapy (methylprednisolone) within the last month
Suicidal thoughts</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>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, the participants will be given a pre-test. The pre-test includes 3 questionnaires to assess and measure dependent variables. Then, the intervention group will receive dialectical behavior therapy for 3 months (12 sessions, one session per week) and finally, they will be given a post-test.</i_keyword>
      <i_keyword>Control group: Participants will first be given a pre-test. They will not receive any psychological treatment and will only receive their usual medication. Then they will be given a post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mood swings score in the PANAS positive and negative mood questionnaire. Timepoint: A pre-test will be taken before the intervention begins, and a post-test will be taken after the intervention (3 months). Method of measurement: Positive and Negative Emotion Scale (PANAS).</prim_outcome>
      <prim_outcome>Tolerance of Uncertainty score on the Freestone Intolerance of Uncertainty Questionnaire (IUS_27). Timepoint: A pre-test will be taken before the intervention begins, and a post-test will be taken after the intervention (3 months). Method of measurement: Freestone Intolerance of Uncertainty Scale (IUS_27).</prim_outcome>
      <prim_outcome>Interpersonal Problems Score on the Barkham Inventory of Interpersonal Problems(IIP-32). Timepoint: A pre-test will be taken before the intervention begins, and a post-test will be taken after the intervention (3 months). Method of measurement: Barkham Inventory of Interpersonal Problems(IIP-32).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Tehran University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Kashan University of Medical Sciences</source_name>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-08</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Room 3529, Research Vice-Chancellor, Kashan University of Medical Sciences, 5th km of Ravand Road, kashan kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
