<?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>IRCT20180522039786N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Preparing a phenomenological package for Healthy Life Style Treatment Based on Acceptance and Combination  and Compare the Effect of Its Combination with Mindfulness Based on Cognitive Therapy on Self-care,Ressilience,Depression,Adherence to Treatment &amp; Glycated Hemoglobin</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of the Therapeutic Life-based Appearance Package Based on Adoption Therapy and the Special Therapeutic Commitment of Female Patients with Type 2 Diabetes and Its Comparative Effect with Mindfulness-Based Cognitive Therapy, Self-Care, Resilience, Depression, Adherence to Treatment, and Glycosylated Hemoglobin</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-06-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31936</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>2</phase>
      <hc_freetext>Diabetes mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Life style health package based on acceptance and commitment. Intervention 2: Intervention group: MBCT. Intervention 3: Control group: 15 people without medical intervention.</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 can be shared after unidentifiable people

When:
2021

To whom:
For researchers, diabetes will be available at university institutes

Conditions:
Use of any documentation is allowed for scholars.

Where to obtain:
Maryam hor
Marya.hor@khuisf.ac.ir

How to obtain:
Posting emails and surveys will allow the submission of documentation.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Hor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Isfahan (Khorasgan) branch, Arqavanieh, Jay Street, Isfahan, Iran</address>
        <city>Isfhan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>158-81595</zip>
        <telephone>+98 983115354001</telephone>
        <email>Marya.Hor@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Hor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Isfahan (Khorasgan) branch, Arqavanieh, Jay Street, Isfahan, Iran</address>
        <city>Isfhan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>158-81595</zip>
        <telephone>+98 31 1535 4001</telephone>
        <email>MaryaHor@khuisf.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Informed consent,.
,Definite diagnosis of type 2 diabetes is at least one year old,
Age range between 35 and 69 years
Medium to severe depression score and low or moderate score in resilience
Access to patients and their lack of participation in other research projects simultaneously</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>69 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having acute psychiatric disorder based on clinical interview,</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>E10-E14</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Life style health package based on acceptance and commitment</i_keyword>
      <i_keyword>Intervention group: MBCT</i_keyword>
      <i_keyword>Control group: 15 people without medical intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in Beck questionnaire is higher than 10,. Timepoint: Trimester. Method of measurement: . Back depression inventory (1961).</prim_outcome>
      <prim_outcome>Resonance increase based on Connor and Davidson questionnaire above 30. Timepoint: Trimester. Method of measurement: Resilience Conner inventory (2003).</prim_outcome>
      <prim_outcome>Increased self-care based on the scale of self-care activities of diabetic patients (SDSCA) above 4. Timepoint: Trimester. Method of measurement: Tobert self-care inventory (2000),.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Glycosylated hemoglobin decreased by less than 6.5. Timepoint: Trimester. Method of measurement: Electrophoresis test in medical diagnostic laboratory.</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>personal</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-13</approval_date>
        <contact_name>Ethics committee of Islamic Azad University,Isfahan(khorasgan)Branch</contact_name>
        <contact_address>Islamic Azad University, Isfahan (Khorasgan) branch, Arqavanieh, Jay Street, Isfahan, Iran. Box: 81595-158 Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
