<?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>IRCT20230831059310N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of ECBT and MCT on Psychological Helplessness, Psychological Cohesion, Social Health, FBS and HbA1c in Patients with Diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effectiveness of Emotion-Focused Cognitive Behavioral Therapy and Metacognitive Therapy on Psychological Helplessness, Psychological Cohesion, Social Health, Fasting Blood Sugar (FBS) and Glycated Hemoglobin (HbA1c) in Patients with Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73061</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients to intervention and control groups was done by lottery. For this purpose, the names of all the people were written on small pieces of paper and put into a box. 3 different sheets with the names of 3 intervention and control groups were also prepared. First, open the sheet of the first intervention group and write the names of the first 20 subjects who came out of the box. For other groups, this process continued until the end (20 people in the second intervention group and 20 people in the control group), Blinding description: All participants were blinded to the way of distribution in groups, possible and expected results, and research assumptions, and no information was provided to them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group, Emotion-Focused Cognitive Behavioral Therapy (ECBT) Group: In this intervention, the ECBT treatment protocol of Sovag, Kendall, Komer and Rubin was used in 10 sessions, each session lasting 90 minutes, one session per week. These sessions were held in person at Saman Clinic. After the initial introduction and establishing communication and creating treatment commitment, we worked on  identifying basic emotions, evaluating the degree of vulnerability and emotional skills, identifying specific emotions that are difficult to understand and regulate, identifying and examining the main beliefs related to emotions, Facilitation in the expression and description of feelings, needs and desires, mental confrontation and coping training, behavioral and physiological consequences of excitement and progressive relaxation training. Intervention 2: Intervention group, Metacognitive Therapy (MCT): The metacognitive therapy protocol of the University of Hamburg, taken from the research of Rajabi, Malihiozakreni, Asadi et al. (2019), was used for 10 sessions, each session lasting 90 minutes, one session per week in person at the Saman clinic. After getting to know the members and the therapist with each other, the following issues were discussed in the therapy sessions: Familiarity with the metacognitive model, identification of metacognitive beliefs related to the definition of memory, hasty conclusions, identification of irrational metacognitive beliefs about exaggerating negative events and minimizing positive events and the cycle defective thoughts, identification of values ​​and strategies for living based on values, assessment of negative metacognitive beliefs related to risk and examination of negative feelings about illness and identification of negative sculptural thoughts. Intervention 3: Control group: This group did not receive any intervention during the research.</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 Its release schedule is not yet known</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Jelodari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir almomenin university complex, Moazen Blvd., Rajaee Shahr.</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3425 9571</telephone>
        <email>samira.jelodari@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samira Jelodari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir almomenin university complex, Moazen Blvd., Rajaee Shahr.</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3425 9571</telephone>
        <email>samira.jelodari@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of type 2 diabetes by a doctor, treated with oral drugs, glycosylated hemoglobin level between 6.5% and 8.5%, age range 45 to 60 years, having at least a diploma education, not receiving other psychological treatments, not suffering from other physical and mental illnesses and not taking psychoactive drugs or substance abuse</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group, Emotion-Focused Cognitive Behavioral Therapy (ECBT) Group: In this intervention, the ECBT treatment protocol of Sovag, Kendall, Komer and Rubin was used in 10 sessions, each session lasting 90 minutes, one session per week. These sessions were held in person at Saman Clinic. After the initial introduction and establishing communication and creating treatment commitment, we worked on  identifying basic emotions, evaluating the degree of vulnerability and emotional skills, identifying specific emotions that are difficult to understand and regulate, identifying and examining the main beliefs related to emotions, Facilitation in the expression and description of feelings, needs and desires, mental confrontation and coping training, behavioral and physiological consequences of excitement and progressive relaxation training.</i_keyword>
      <i_keyword>Intervention group, Metacognitive Therapy (MCT): The metacognitive therapy protocol of the University of Hamburg, taken from the research of Rajabi, Malihiozakreni, Asadi et al. (2019), was used for 10 sessions, each session lasting 90 minutes, one session per week in person at the Saman clinic. After getting to know the members and the therapist with each other, the following issues were discussed in the therapy sessions: Familiarity with the metacognitive model, identification of metacognitive beliefs related to the definition of memory, hasty conclusions, identification of irrational metacognitive beliefs about exaggerating negative events and minimizing positive events and the cycle defective thoughts, identification of values ​​and strategies for living based on values, assessment of negative metacognitive beliefs related to risk and examination of negative feelings about illness and identification of negative sculptural thoughts</i_keyword>
      <i_keyword>Control group: This group did not receive any intervention during the research.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological Helplessness. Timepoint: Before the start of the intervention, after the end of the intervention and three months after the end of the intervention. Method of measurement: Depression, Anxiety, Stress Scale (DASS-21).</prim_outcome>
      <prim_outcome>Psychological Cohesion. Timepoint: Before the start of the intervention, after the end of the intervention and three months after the end of the intervention. Method of measurement: Sense of Coherence Questionnaire.</prim_outcome>
      <prim_outcome>Social Health. Timepoint: Before the start of the intervention, after the end of the intervention and three months after the end of the intervention. Method of measurement: Social Well-Being Questionnaire.</prim_outcome>
      <prim_outcome>Fasting Blood Sugar (FBS). Timepoint: Before the start of the intervention, after the end of the intervention and three months after the end of the intervention. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Glycated Hemoglobin (HbA1c). Timepoint: Before the start of the intervention, after the end of the intervention and three months after the end of the intervention. Method of measurement: Blood Test.</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>2022-08-31</approval_date>
        <contact_name>Islamic Azad University Ethic Committee-Karaj Branch</contact_name>
        <contact_address>Amir almomenin university complex, Moazen Blvd, Rajaee Shahr. Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
