<?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>IRCT20260719070251N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-17</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effectiveness of cognitive-behavioral therapy and cognitive therapy based on mindfulness in patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of cognitive-behavioral therapy and mindfulness-based cognitive therapy on cognitive emotion regulation, psychological well-being, diabetes-related distress, and self-care in patients with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/91804</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1:Patients with type 2 diabetes who are assigned to this group will receive Mindfulness-Based Cognitive Therapy (MBCT) over 8 weekly sessions. The sessions will include mindfulness training and exercises, body scan, focused breathing, awareness of thoughts and emotions, acceptance, seated meditation, and other exercises specified in the treatment protocol. Intervention 2: Intervention group: Intervention Group 2:Patients with type 2 diabetes who are assigned to this group will receive Cognitive Behavioral Therapy (CBT) over 12 weekly sessions. The sessions will include education about diabetes and psychological factors, identification of automatic thoughts, behavioral activation, goal setting, identification of cognitive distortions, cognitive restructuring, and relapse prevention. Intervention 3: Control group: Control Group:Patients with type 2 diabetes who are assigned to the control group will not receive any psychological intervention during the intervention period and will be placed on a waiting list. After completion of the study, the intended treatment will be provided to this 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>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 Based on the protocol of Islamic Azad University</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Zamanpoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khazar Sq</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48164-194</zip>
        <telephone>+98 11 3303 2891</telephone>
        <email>Rohaaam2018@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahram Mirzaian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khazar Sq</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>48164-194</zip>
        <telephone>+98 11 3303 2891</telephone>
        <email>Bahrammirzaian@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Getting a diagnosis of type 2 diabetes from an endocrinologist
Age between 25 and 45 years
She has not taken any psychiatric medication in the past three months.
Not have a terminal physical illness such as cancer, MS, Alzheimer's, etc.
Do not suffer from a serious psychiatric illness such as psychosis or the like (based on the initial clinical interview)
They must have at least a high school diploma.
Complete an informed consent agreement regarding participation in the research project.
Do not undergo treatment or other psychological interventions during the research.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of a severe and active psychiatric disorder, including psychotic disorders or a manic episode, based on the initial clinical interview.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1:Patients with type 2 diabetes who are assigned to this group will receive Mindfulness-Based Cognitive Therapy (MBCT) over 8 weekly sessions. The sessions will include mindfulness training and exercises, body scan, focused breathing, awareness of thoughts and emotions, acceptance, seated meditation, and other exercises specified in the treatment protocol.</i_keyword>
      <i_keyword>Intervention group: Intervention Group 2:Patients with type 2 diabetes who are assigned to this group will receive Cognitive Behavioral Therapy (CBT) over 12 weekly sessions. The sessions will include education about diabetes and psychological factors, identification of automatic thoughts, behavioral activation, goal setting, identification of cognitive distortions, cognitive restructuring, and relapse prevention.</i_keyword>
      <i_keyword>Control group: Control Group:Patients with type 2 diabetes who are assigned to the control group will not receive any psychological intervention during the intervention period and will be placed on a waiting list. After completion of the study, the intended treatment will be provided to this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive emotion regulation. Timepoint: Before intervention. Method of measurement: After intervention.</prim_outcome>
      <prim_outcome>: Psychological well-being. Timepoint: before intervention. Method of measurement: after intervention.</prim_outcome>
      <prim_outcome>Diabetes distress. Timepoint: before intervention. Method of measurement: after intervention.</prim_outcome>
      <prim_outcome>Self-care. Timepoint: before intervention. Method of measurement: after intervention.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Self-care. Timepoint: Before intervention. Method of measurement: After intervention.</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>2026-05-25</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Sari Branch</contact_name>
        <contact_address>7th km of Darya Road (Farahabad), Azad University Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
