<?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>IRCT20200226046625N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Cognitive-Behavioral Therapy Based on Mindfulness and Education on Health Promoting Lifestyle in In treatment of diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Cognitive-Behavioral Therapy Based on Mindfulness and Education on Health Promoting Lifestyle on Psychological Well-being, Hope and Quality of Life in Patients with Diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization method is performed by the statistical consultant as follows: Randomization is performed in 3 groups of Cognitive-Behavioral Therapy based on mindfulness, health-promoting lifestyle training and control group: First, the list of eligible people is provided and coded. Be. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows:
 A = Mindfulness-based Cognitive-Behavioral Therapy, B = Health-Promoting Lifestyle Training, and C Control Group
In this study with three groups A, B and C we create the following six groups and assign 1 to 6 each:
ABC-ACB-BAC-BCA-CAB-CBA
Then we use a random number table to select one of these blocks whenever the numbers 1, 2, 3, 4, 5, 6 appear, and if the other number appears, consider null and go to the next choice. In fact, we have obtained a random sequence of numbers with a random number table that we consider the order of assignment for each number. This way the number of people in the groups will be approximately equal.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: In the present study, the goal of mindfulness-based cognitive-behavioral therapy is 8 sessions of mindfulness-based cognitive-behavioral therapy that were held two sessions per week (one month) and each session 60 minutes. Intervention 2: Intervention group 2: In this study, the purpose of health promoting lifestyle training is 10 sessions of health promoting lifestyle training that were held two sessions per week (one and a half months) and each session 60 minutes. Intervention 3: Control group: No 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:
Only part of the data, such as information about the main outcome or the like, can be shared.

When:
Start of access period 6 months after printing results

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

Conditions:
Any type of analysis on the data delivered is permitted

Where to obtain:
Maryam Ghorbani
Sattarkhan St., Khosrow South, Atabaki Mehr Ave.

How to obtain:
The request will be sent by email to: m.ghorbani@iaukishint.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattarkhan St., Khosrow South, Atabaki Mehr Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2245986743</zip>
        <telephone>+98 21 6655 9783</telephone>
        <email>m.ghorbani@iaukishint.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattarkhan St., Khosrow South, Atabaki Mehr Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2245986743</zip>
        <telephone>+98 21 6655 9783</telephone>
        <email>m.ghorbani@iaukishint.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having type 2 diabetes with a doctor's approval for at least one year
Hemoglobin A1c levels above 7%
Minimum age of 20 and maximum of 50 years
Minimum secondary education equivalent
Lack of psychological treatment since diagnosis
Lack of acute or chronic medical illnesses such as epilepsy, skeletal diseases, heart and respiratory failure, etc. which can cause problems in blood sampling and long sessions
Lack of severe mental illness such as psychotic disorders
No psychotropic drugs or substance abuse at present</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe complications of diabetes that lead to hospitalization
absence of more than two sessions in treatment sessions
major stress due to unforeseen events</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: In the present study, the goal of mindfulness-based cognitive-behavioral therapy is 8 sessions of mindfulness-based cognitive-behavioral therapy that were held two sessions per week (one month) and each session 60 minutes.</i_keyword>
      <i_keyword>Intervention group 2: In this study, the purpose of health promoting lifestyle training is 10 sessions of health promoting lifestyle training that were held two sessions per week (one and a half months) and each session 60 minutes.</i_keyword>
      <i_keyword>Control group: No Intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological Well-being. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Ryff Psychological Well-being Scale.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: The World Health Organization Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Hopefulness. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Snyder hope scale.</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>2019-12-07</approval_date>
        <contact_name>Ethics committee of Hormozgan University Of Medical Sciences</contact_name>
        <contact_address>No. 64, Janbazan Ave., North Karegar Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
