<?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>IRCT20200916048737N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-16</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of metacognitive therapy and reality therapy on self-care behavior, quality of life, depression and biological variables in patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of metacognition Versus therapeutic reality ‎on the treatment of care, quality of life, depression and biological variables ‎in type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51022</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization; because we have three study groups, name each group with the English letters A. B and C and write the letters A, B and C in three envelopes or three pieces of paper and close them and then randomly remove one of the envelopes. And according to the letter inserted in that person, we attribute it to that group, and with the arrival of the second person, we choose one of the two remaining envelopes and assign that person to that group, and then the third person to the group written in the next envelope. Which has not been selected in the previous two selections will be awarded and for the fourth to sixth persons the steps 2 to 5 will be repeated and then for the next three persons and ... until the required number of samples is completed in all three groups, Blinding description: Participants will be unaware of the allocation of intervention groups, ie which treatment group they will be in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Reality therapy in 8 sessions, Reality therapy protocol: Session 1: Greetings and acquaintance of group members with each other, group rules and establishing emotional relationships between members and therapist and performing tests Session 2: Training Concepts of reality therapy and examining and focusing on self-knowledge, identifying the strengths and weaknesses of people. Session 3: Introducing general behavior and acquainting people with the four components of general behavior (thought, action, feeling and physiology), teaching decision-making skills and The importance of the present in this treatment Session 4: Explain and introduce the four conflicts and forced behaviors of the session 5: Familiarity with emotions such as depression from the perspective of reality therapy and relaxation skills training Session 6: Introducing destructive and constructive behaviors in relationships and life education Session 7: Teaching the ten principles of the theory of choice and responsibility Classification and execution of tests. Intervention 2: Intervention group 2: Metacognitive therapy which contains 8 sessions.Therapeutic protocol of metacognitive therapySession 1: Performing tests, stating the rules, establishing a therapeutic relationship and proper communication between membersSession 2: Explaining the logic of metacognition, teaching documents: blaming or gaining credibility and recognitionSession 3: Review the previous session and teach the topic of early conclusionSession 4: Review previous sessions and learn how to change the belief systemSession 5: Review previous sessions and empathy trainingSession 6: Review previous sessions and memory enhancement trainingSession 7: Reviewing previous sessions and learning to avoid prejudice (tagging)Session 8: Review the previous sessions and teach self-esteem and mood and test performance. Intervention 3: Control group: Control group: This group does not receive treatment until the end of the sessions and until the quarterly follow-up, but in the end, if desired, metacognitive and reality therapies are performed on them.</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:
Only part of the data, such as information about the main outcome or the like, can be shared.

When:
The access period starts after printing

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
In case of similar and complementary researches, the information of the present research will be available

Where to obtain:
Contact by email 
nasirdehghanmaryam58@gmail.com

How to obtain:
The applicant is required to email his / her scientific research documents and after access, he / she can access the information.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Tahmouresi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Karaj, Moazzen Boulevard, Rajai Shahr, Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3418 2301</telephone>
        <email>niloofartahmouresi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Nasirdehghan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Karaj, Moazzen Boulevard, Rajai Shahr, Karaj</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3425 9571</telephone>
        <email>nasirdehghanmaryam58@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Completion and signing of written consent by the subject
No abuse of drugs and psychotropic drugs
Age between 30-60 years
More than a year has passed since the diagnosis of type 2 diabetes
The minimum depression score is 8
Fasting sugar should not exceed 135 mg per deciliter
HbA1c should not exceed 8%
Failure to receive psychological treatment during the last 3 months
Absence of severe physical diseases caused by diabetes such as kidney failure, vision and ...</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Development of severe physical diseases caused by diabetes such as kidney failure, vision and ...
Receiving psychological therapies during the intervention
Consumption of any sedative or neuropsychiatric drugs
Increase in the dose of diabetes-related drugs
More than two absences</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Reality therapy in 8 sessions, Reality therapy protocol: Session 1: Greetings and acquaintance of group members with each other, group rules and establishing emotional relationships between members and therapist and performing tests Session 2: Training Concepts of reality therapy and examining and focusing on self-knowledge, identifying the strengths and weaknesses of people. Session 3: Introducing general behavior and acquainting people with the four components of general behavior (thought, action, feeling and physiology), teaching decision-making skills and The importance of the present in this treatment Session 4: Explain and introduce the four conflicts and forced behaviors of the session 5: Familiarity with emotions such as depression from the perspective of reality therapy and relaxation skills training Session 6: Introducing destructive and constructive behaviors in relationships and life education Session 7: Teaching the ten principles of the theory of choice and responsibility Classification and execution of tests</i_keyword>
      <i_keyword>Intervention group 2: Metacognitive therapy which contains 8 sessions.Therapeutic protocol of metacognitive therapySession 1: Performing tests, stating the rules, establishing a therapeutic relationship and proper communication between membersSession 2: Explaining the logic of metacognition, teaching documents: blaming or gaining credibility and recognitionSession 3: Review the previous session and teach the topic of early conclusionSession 4: Review previous sessions and learn how to change the belief systemSession 5: Review previous sessions and empathy trainingSession 6: Review previous sessions and memory enhancement trainingSession 7: Reviewing previous sessions and learning to avoid prejudice (tagging)Session 8: Review the previous sessions and teach self-esteem and mood and test performance</i_keyword>
      <i_keyword>Control group: Control group: This group does not receive treatment until the end of the sessions and until the quarterly follow-up, but in the end, if desired, metacognitive and reality therapies are performed on them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention, immediately after the intervention and one month and three months later. Method of measurement: Beck Depression Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Before the intervention, immediately after the study and one month and three months later. Method of measurement: SF36 Health Status Questionnaire.</sec_outcome>
      <sec_outcome>Self care. Timepoint: Before the intervention, immediately after the study and one month and three months later. Method of measurement: Tobert and Glasgow Self-Care Questionnaire.</sec_outcome>
      <sec_outcome>Fasting blood sugar. Timepoint: Before the intervention, immediately after the study and one month and three months later. Method of measurement: blood test.</sec_outcome>
      <sec_outcome>Glycosylated hemoglobin. Timepoint: Before the intervention, immediately after the study and one month and three months later. Method of measurement: Blood test.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before the intervention, immediately after the study and one month and three months later. Method of measurement: Analog blood pressure monitor.</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, Karaj Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-09</approval_date>
        <contact_name>Ethics Committee of Karaj Azad University</contact_name>
        <contact_address>Moazzen Boulevard,Rajai Shahr Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
