<?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>IRCT20251019067681N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-09</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of short-term object relations therapy on patients with multiple sclerosis.</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Short-Term Object Relations Therapy on Self-Efficacy, Identity Reconstruction, Trauma-Related Shame and kinesiophobia in Patients with Multiple Sclerosis (MS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86920</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Experimental and control groups: After selecting the sample, the next step involves dividing people into experimental and control groups using a random method.
How to perform randomization: First step: After selecting the voluntary sample, all selected people are placed on a list (numbers from one to 36 are assigned to people). Second step: From these individuals, a random method is used with sealed and opaque (numbered) envelopes to divide them into experimental and control groups. Each person randomly selects an envelope and is divided into the corresponding group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 18 participants who meet the inclusion criteria will be randomly assigned to the control group and will complete the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Stapelman et al. Identity Reconstruction Inventory (IRAS), the Trauma-Related Shame Inventory (TRSI), and the Tampa Fear of Movement Scale (TSK), but will not receive any treatment. Intervention 2: Intervention group: 18 patients with multiple sclerosis referred to Kashani and Al-Zahra hospitals in Isfahan, who meet the inclusion criteria, will participate in the study as the intervention group randomly. They will complete the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Identity Reconstruction Scale (IRAS), the Trauma-Related Shame Scale (TRSI), and the Tampa Fear of Movement Scale (TSK) as a pre-test, then they will undergo 14 sessions of 90 minutes in the Ostadter 2009 short-term object relations group psychotherapy sessions. And after completing the sessions, they will complete the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Identity Reconstruction Scale (IRAS), the Trauma-Related Shame Scale (TRSI), and the Tampa Fear of Movement Scale (TSK) as 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 data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.

When:
Data can be made available 4 months after the results are published and after personally identifiable information is removed.

To whom:
The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions.

Conditions:
Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential.

Where to obtain:
If you need data, please contact ghazal.mesghali7412@iau.ir

How to obtain:
After receiving and reviewing the request from the researcher, the request will be responded to as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ghazal Mesghali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirkabir Boulevard, Najafabad, Isfahan Province, Iran</address>
        <city>isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8194953479</zip>
        <telephone>+98 903 039 1911</telephone>
        <email>ghazal.mesghali7412@iau.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Najafabad Branch, Daneshgah Boulevard, Najafabad, Isfahan, Iran</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514143131</zip>
        <telephone>+98 913 317 0681</telephone>
        <email>rezatalebi@smd.iaun.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>20 to 50 years old
Minimum literacy and ability to complete questionnaires
Willingness to participate and sign informed consent</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having severe psychiatric disorders (active psychosis, severe substance dependence, etc.)
Receiving other concurrent psychotherapy interventions during the study period</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>Control group: 18 participants who meet the inclusion criteria will be randomly assigned to the control group and will complete the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Stapelman et al. Identity Reconstruction Inventory (IRAS), the Trauma-Related Shame Inventory (TRSI), and the Tampa Fear of Movement Scale (TSK), but will not receive any treatment.</i_keyword>
      <i_keyword>Intervention group: 18 patients with multiple sclerosis referred to Kashani and Al-Zahra hospitals in Isfahan, who meet the inclusion criteria, will participate in the study as the intervention group randomly. They will complete the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Identity Reconstruction Scale (IRAS), the Trauma-Related Shame Scale (TRSI), and the Tampa Fear of Movement Scale (TSK) as a pre-test, then they will undergo 14 sessions of 90 minutes in the Ostadter 2009 short-term object relations group psychotherapy sessions. And after completing the sessions, they will complete the Multiple Sclerosis Self-Efficacy Scale (MSSS), the Identity Reconstruction Scale (IRAS), the Trauma-Related Shame Scale (TRSI), and the Tampa Fear of Movement Scale (TSK) as a post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-Efficacy. Timepoint: Before intervention and after intervention. Method of measurement: Multiple Sclerosis Self-Efficacy Questionnaire (MSSS) Rigby et al. 2003.</prim_outcome>
      <prim_outcome>Identity Reconstruction. Timepoint: Before intervention and after intervention. Method of measurement: Identity Reconstruction Questionnaire for Multiple Sclerosis (IRAS) Stapleman et al.</prim_outcome>
      <prim_outcome>Trauma-Related Shame. Timepoint: Before intervention and after intervention. Method of measurement: Trauma-Related Shame Inventory (TRSI).</prim_outcome>
      <prim_outcome>Kinesiophobia. Timepoint: Before intervention and after intervention. Method of measurement: Tampa Scale (TASK-11).</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>2025-09-25</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University- Najafaba Branch</contact_name>
        <contact_address>Islamic Azad University, Najafabad Branch, Daneshgah Boulevard, Najafabad, Isfahan, Iran Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
