<?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>IRCT20191012045072N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>the effectiveness of ACT &amp; CFT in Diabetic non-clinical patients Depressed</public_title>
      <acronym></acronym>
      <scientific_title>Lipid and Plasma lipo proteins, Blood glucose index, Negative process self-referral psychological syndrome:the effectiveness of Acceptance and Commitment Therapy with treatment based on Compassion in Diabetic non-clinical patients Depressed</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42969</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to select and place people in two experimental groups and a control group, a simple random method was used. In order to place people in groups, the number of people, ie 33 people, was defined from 1 to 33 codes and the codes were written on paper and in They were placed in a container. Finally, each person randomly removed a code from the container and the selected code was written in the desired group (codes 1 to 11: intervention group 1, codes 12 to 22: intervention group 2, codes 23 to 33: control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetics.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group 1: acceptance, commitment and practice, 8 sessions per week and each session of 90 minutes of psychological treatment in connection with the acceptance of thoughts and commitment of the patient to positive change in order to achieve the goals". Intervention 2: Intervention group 2: Acceptance, commitment and action with compassion, including 16 sessions twice a week for 2 hours, to increase self-compassion, knowledge of emotional emotional systems, etc. to improve the quality of life In order to achieve the goals. Intervention 3: Control group: This group does not receive any psychological interventions and treatment. ".</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:
all personal data of study participants are identifiable after identifiable individuals are shared

When:
Start the course after six months the result are published

To whom:
personal in academic in institutions

Conditions:
drama counselling centers and hospitals

Where to obtain:
refer to my personal email adress  rpanahi.1366@gmail.com

How to obtain:
responding to your request after 10 business days

Comments:
thanks for your cooperation</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reyhane Panahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand, Ghaffari St., Nasrin 7, No. 4</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188793487</zip>
        <telephone>+98 51 3609 6870</telephone>
        <email>rpanahi.1366@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reyhane Panahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Birjand, Ghaffari St., Nasrin 7, No. 4</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188793487</zip>
        <telephone>+98 51 3609 6870</telephone>
        <email>RPANAHI.1366@GMAIL.COM</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate

Diabetes disease at least for 2 years
High-fat lipoprotein( for women less than 60 mg/dl, for man less than 40 mg/dl)
Low-Fat lipoprotein (100-130 mg/dl)
Cholesterol less than 200 mg/dl
Triglycerides (150 -160)
Fasting blood sugar less than 110
Hemoglobin A1c less than 5.5</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>kidney, heart, liver, lung, inflammatory, chronic gastrointestinal disease, thyroid disorder
Insulin-dependent injection
Taking estrogen and progesterone
Addiction
Lactase intolerance
Taking herbal medicines
obvious psychology disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group 1: acceptance, commitment and practice, 8 sessions per week and each session of 90 minutes of psychological treatment in connection with the acceptance of thoughts and commitment of the patient to positive change in order to achieve the goals"</i_keyword>
      <i_keyword>Intervention group 2: Acceptance, commitment and action with compassion, including 16 sessions twice a week for 2 hours, to increase self-compassion, knowledge of emotional emotional systems, etc. to improve the quality of life In order to achieve the goals.</i_keyword>
      <i_keyword>Control group: This group does not receive any psychological interventions and treatment. "</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plasma lipids and lipoproteins. Timepoint: One month before the intervention, 7 and 30 days after the intervention. Method of measurement: CBC test and use of Pars Azmon laboratory kits.</prim_outcome>
      <prim_outcome>Negative self-referential processors. Timepoint: 7 and 30 days after the intervention. Method of measurement: Anger rumination scale, self-critical rumination, Diabetes distress screening scale Questionnaire.</prim_outcome>
      <prim_outcome>Psychological symptoms. Timepoint: 30 days before the intervention and 7 and 30 after the intervention. Method of measurement: Pennsylvania Worry Questionnaire, Diabetes Anxiety -Depression scale type 2 , Patient Health.</prim_outcome>
      <prim_outcome>Blood sugar index. Timepoint: One month before the intervention, 7 and 30 after the intervention. Method of measurement: CBC test and use of Pars Azmon laboratory kits.</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>2019-05-02</approval_date>
        <contact_name>Ethics Committe of Birjand University of medical science</contact_name>
        <contact_address>Nasrin 7.3, Ghafarri ave, Birjand city Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
