<?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>IRCT20191023045222N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Compassionate Therapy and Positive Psychology with Well-being Approach on Alexithymia, Adaptive Behavior, Adherence of Treatment and Biological Factors in Patients with Diabetes Type2</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Compassionate Therapy and Positive Psychology with Well-being Approach on Alexithymia, Adaptive Behavior, Adherence of Treatment and Biological Factors in Patients with Diabetes Type2</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46367</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: By referring to the endocrinology department of Golestan Hospital, under the supervision of a specialist doctor who is my advisor in this research and by participating in the Great Diabetes Conference by preparing the consent form for participating in the course and demographic form and giving the necessary explanations, out of 500 people, 110 people announced their readiness. Then the names of the individuals were written one by one on the specific size sheets and the names were selected by lottery in the box, Blinding description: Individuals were divided into three groups.
Apart from the control group, which did not intervene and only answered the questionnaires, the other two groups participated in educational-therapeutic classes, but without knowing in which aspect there was a change, effectiveness or effect.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Compassionate Therapy group. Intervention 2: Intervention group 2 : Positive psychology. Intervention 3: Control 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Participants' personal information will not be published, but data analysis is required in Chapter Four, as it relates to the PhD thesis.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Bahadori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 142, Niloofar Ave, Newside</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6173933481</zip>
        <telephone>+98 61 3443 4091</telephone>
        <email>m.bahadori96@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Mehrabizadeh Honarmand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 338,  Laleh Ave, Ostadan Town</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135713773</zip>
        <telephone>+98 912 604 9225</telephone>
        <email>m-mehrabizadeh@yahoo.com</email>
        <affiliation>Shahid Chamran University of Ahvaz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with type 2 diabetes for more than six months
High school education or more
Patient willingness and satisfaction to participate in research
30 years old or above</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of mental disorder
type 1 diabetes
Gestational Diabetes
Diabetes is caused by other factors</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 group 1: Compassionate Therapy group</i_keyword>
      <i_keyword>Intervention group 2 : Positive psychology</i_keyword>
      <i_keyword>Control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alexithymia. Timepoint: It is before the intervention and 8 sessions later (two sessions per week). Method of measurement: Toronto Alexithymia Scale.</prim_outcome>
      <prim_outcome>Adaptive Behavior. Timepoint: It is before the intervention and 8 sessions later (two sessions per week). Method of measurement: The Psychosocial Adjustment to Illness Scale (PAIS).</prim_outcome>
      <prim_outcome>Adherence of Treatment. Timepoint: It is before the intervention and 8 sessions later (two sessions per week). Method of measurement: Modanloo adherence of treatment scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mental health. Timepoint: After the intervention. Method of measurement: use Psycho-social Adjustment with Illness Scale.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: After the intervention. Method of measurement: use Modanlo Adherence of Treatment questionnaire.</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>2020-05-18</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Shahid chamran Blvd. Hormozgan Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
