<?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>IRCT20250523065853N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-07</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Mindfulness-Based Cognitive Therapy for Mothers of Children with Intellectual Disabilities</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Mindfulness-Based Cognitive Therapy on Depression, Dysfunctional Beliefs, and Self-Esteem in Mothers of Children with Intellectual Disabilities</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93071</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression, dysfunctional beliefs, and self-esteem in mothers of children with intellectual disabilities, without a specific clinical diagnosis..</hc_freetext>
      <i_freetext>Mothers of children with intellectual disabilities who receive Mindfulness-Based Cognitive Therapy (MBCT) will participate in nine weekly two-hour sessions. The intervention includes training in mindfulness skills, techniques for managing negative thoughts, and practicing nonjudgmental acceptance..</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:
De-identified Participant Data: An anonymized dataset including participant codes, demographic information, and pretest and posttest scores for depression, dysfunctional beliefs, and self-esteem.
Study Protocol:The study protocol including the research objectives, methodology, inclusion and exclusion criteria, description of the Mindfulness-Based Cognitive Therapy (MBCT) intervention, and outcome measures.
Statistical Analysis Plan:A statistical analysis plan describing the methods used to analyze the data and compare the experimental and control groups at the pretest and posttest stages.
Informed Consent Form:The participant information sheet and informed consent form used in the study (Persian version).
Analytical Codes: SPSS syntax files used for data entry, cleaning, management, and statistical analysis.
Data Dictionary: A data dictionary defining the variables included in the anonymized dataset, including variable names, definitions, data types, and coding schemes.

When:
The data and documents will become publicly available upon acceptance for publication of the primary results manuscript. They will be stored with no end date for access.

To whom:
Available to researchers, students, and meta-analysts in the scientific community worldwide.

Conditions:
Data and documents may be used for non-commercial, scientific purposes such as validation, meta-analysis, methodological research, or educational purposes. Any proposed use must be approved by an independent scientific review committee and must comply with ethical standards.

Where to obtain:
The documents (Protocol, SAP, Consent Form) will be attached to the trial registration on the Iranian Registry of Clinical Trials (IRCT). The final, shareable versions of all items will be deposited in a public, open-access repository such as Mendeley Data, Figshare, or Zenodo. A direct link (DOI) will be provided in the published manuscript and updated in this registry entry.

How to obtain:
For the deidentified IPD: A managed access process is required. Requestors must submit a brief proposal outlining their intended use, analysis plan, and ethical approval to the Corresponding Author (Dr. Mehdi Amiri) via email. Requests will be reviewed by the study's principal investigator within 4 weeks. Approved requestors will be granted access via the repository with a unique token or will receive the data directly.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra saedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۱۷۷۹۴۸۹۵۴</zip>
        <telephone>+98 916 604 6877</telephone>
        <email>darya2674@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Administration, Central Building, Vakilabad Boulevard, Mashhad University of Medical Sciences, Mashhad, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۹۱۷۷۹۴۸۹۵۴</zip>
        <telephone>+98 915 914 1563</telephone>
        <email>amirime@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a child with an intellectual disability with a confirmed diagnosis provided by a specialist physician or rehabilitation center.
Having at least basic literacy skills (reading and writing) to understand the session materials and complete the research instruments.
No severe psychiatric disorders, based on self-report and treatment history.
Not receiving other similar psychological interventions or specific pharmacological treatment for depression concurrently during the study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absence from more than two intervention sessions.
Failure to cooperate in completing the questionnaires or withdrawal from participation at any stage of the study.
The occurrence of new medical or psychological conditions that interfere with the intervention process.
Diagnosis of a severe psychiatric disorder during the study, based on clinical assessment and medical records.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F30-F39</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders due to psychoactive substance use</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Mothers of children with intellectual disabilities who receive Mindfulness-Based Cognitive Therapy (MBCT) will participate in nine weekly two-hour sessions. The intervention includes training in mindfulness skills, techniques for managing negative thoughts, and practicing nonjudgmental acceptance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression, Dysfunctional Beliefs , Self-Esteem. Timepoint: Pretest: Before the intervention and Posttest: Immediately after the intervention. Method of measurement: Depression will be assessed using the Beck Depression Inventory (BDI), self-esteem using the Coopersmith Self-Esteem Inventory (CSEI), and dysfunctional beliefs using the Dysfunctional Attitude Scale (DAS). The questionnaires will be administered to both groups at pretest and posttest.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-09-02</approval_date>
        <contact_name>Mashhad university of medical science</contact_name>
        <contact_address>Bahar 2, Baharestan Dormitory, Hejab Boulevard, Mashhad University of Medical Sciences, End of Bahonar Boulevard, Mashhad, Iran Masshad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
