<?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>IRCT20240211060960N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effectiveness of mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy on self-care activities, practice and acceptance of diabetes, fear of hypoglycemia, and quality of life in patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of mindfulness-based cognitive therapy (MBCT) and acceptance and commitment therapy on self-care activities, practice and acceptance of diabetes, fear of hypoglycemia, and quality of life in patients with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77650</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: It will be done through simple randomization. According to this method, the names of each selected member are written on the paper as an example of the research. They are thrown into a box for drawing, then picking the paper pieces one by one and the first 15 (1-15) part of the Cognitive Therapy Experimental Group. On the consciousness, 15 seconds (16 to 30) of the Acceptance and commitment Experimental group and the last 15 (31 to 45) whose names come out of the lottery box will be members of the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Cognitive therapy based on mindfulness: Cognitive therapy based on mindfulness or MBCT is one of the types of therapy based on cognition and behavior.  This therapy integrates presence of mind as a treatment goal with exercises such as conscious thought cessation and non-judgmental observation of one's own thoughts.  Mindfulness emerges through purposeful and non-judgmental attention to the present moment and situation in a specific way. In this research, the experimental group of 8 sessions of 60 minutes each week are treated based on cognitive-behavioral protocol interventions based on mindfulness.  This training program is based on Crane's book on cognitive therapy based on mindfulness. Intervention 2: Intervention group 2: Treatment based on commitment and acceptance: therapy based on commitment and acceptance is a mixture of 4 approaches: awareness, acceptance, commitment and behavior change.  The basis of treatment is based on the acceptance and commitment of Relational Frame Theory (RFT).  which is a result of the third wave of psychotherapy introduced by Steven Hayes and his colleagues in 1982.  The word ACT is actually derived from: A: accepting thoughts and feelings and being in the present, C: choosing a valuable direction and T: acting.  Treatment sessions will be held in the form of 8 sessions of 60 minutes each week. Intervention 3: Control group: The control group will not receive treatment, but after a two-month follow-up, it will undergo treatment sessions chosen by the members.</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:
Part of the data will be published in the student's article and thesis, and the identity information of the participants will be preserved.

When:
Since 1404

To whom:
Academic and scientific researchers

Conditions:
After completing the treatment and follow-up sessions, writing a doctoral thesis, defending the thesis and research articles will be published in reputable scientific journals.

Where to obtain:
Tina karbasi

How to obtain:
A message containing the request for research documents should be sent to the email of the author of the article.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tina Karbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.87, Jalal AlAhmad Ave.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188878361</zip>
        <telephone>+98 51 3604 4326</telephone>
        <email>Karbasit2017@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tina karbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 87, Jalal Al Ahmad 21 Ave</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188878361</zip>
        <telephone>+98 51 3604 4326</telephone>
        <email>Karbasit2017@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Age between 30 and 50 years
- having a minimum cycle degree
- Lack of psychiatric diseases (patients' records questioned by the person as well as consultation by a specialist psychologist and reviewing the patient's medical record at the clinic)
- Failure to use psychiatric drugs
- No drug abuse
Failure to receive any similar training programs before and during interference
- Regular participation in therapeutic sessions (cognitive therapy based on mentality and admission and commitment treatment) according to the therapy
- Having informed consent to participate in the study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Voluntary withdrawal from research
Absence of more than two sessions in training sessions
Lack of proper cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Cognitive therapy based on mindfulness: Cognitive therapy based on mindfulness or MBCT is one of the types of therapy based on cognition and behavior.  This therapy integrates presence of mind as a treatment goal with exercises such as conscious thought cessation and non-judgmental observation of one's own thoughts.  Mindfulness emerges through purposeful and non-judgmental attention to the present moment and situation in a specific way. In this research, the experimental group of 8 sessions of 60 minutes each week are treated based on cognitive-behavioral protocol interventions based on mindfulness.  This training program is based on Crane's book on cognitive therapy based on mindfulness.</i_keyword>
      <i_keyword>Intervention group 2: Treatment based on commitment and acceptance: therapy based on commitment and acceptance is a mixture of 4 approaches: awareness, acceptance, commitment and behavior change.  The basis of treatment is based on the acceptance and commitment of Relational Frame Theory (RFT).  which is a result of the third wave of psychotherapy introduced by Steven Hayes and his colleagues in 1982.  The word ACT is actually derived from: A: accepting thoughts and feelings and being in the present, C: choosing a valuable direction and T: acting.  Treatment sessions will be held in the form of 8 sessions of 60 minutes each week.</i_keyword>
      <i_keyword>Control group: The control group will not receive treatment, but after a two-month follow-up, it will undergo treatment sessions chosen by the members.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of self-care activities in the self-care questionnaire. Timepoint: At the beginning of the study, after treatment sessions and follow-up two months after treatment. Method of measurement: Self-care: In this research, the state of self-care is the score that the subject will get from the self-care questionnaire of patients with diabetes Tobert et al. (2000).</prim_outcome>
      <prim_outcome>The score of diabetes practice and acceptance in the diabetes practice and acceptance questionnaire. Timepoint: At the beginning of the study, after treatment sessions and follow-up two months after treatment. Method of measurement: Acceptance and Action: In this research, acceptance and action are the scores that the subject will get from the Acceptance and Action Questionnaire AAQ-R Bund et al. (2007).</prim_outcome>
      <prim_outcome>The fear of hypoglycemia score in the hypoglycemia questionnaire. Timepoint: At the beginning of the study, after treatment sessions and follow-up two months after treatment. Method of measurement: Quality of life: In this research, quality of life is the score that the subject will get from the questionnaire on the quality of life of diabetic patients by Broth et al. (2004).</prim_outcome>
      <prim_outcome>The quality of life score in the quality of life questionnaire of patients with diabetes. Timepoint: At the beginning of the study, after treatment sessions and follow-up two months after treatment. Method of measurement: Fear of hypoglycemia: In this research, fear of hypoglycemia is the score that the subject will get from the fear of hypoglycemia questionnaire or HFS.</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>2024-04-03</approval_date>
        <contact_name>Ethical Committee of Azad University of Neyshabur branch</contact_name>
        <contact_address>Pazhoohesh Blvd Neyshabur Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
