<?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>IRCT20180404039185N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-05-28</date_registration>
      <primary_sponsor>The university of semnan- Psychology faculty</primary_sponsor>
      <public_title>Effect of ACT on diabetes</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effectiveness of Acceptance and Commitment Therapy with the Lifestyle Intervention of  promoting health on disease perception, disease adjustment, and HbA1c Levels in Type II Diabetes patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30452</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method is simple random sampling. Having matched the samples in terms of age and gender, a number in the range of one to three will be given to evry group. Then the numbers randomly will be assigned to the title of evry group, like control group, ACT group and lifestyle group by a computeized program.</study_design>
      <phase>N/A</phase>
      <hc_freetext>diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acceptance and commitment therapy (ACT). The name of ACT stemming from one of its main message: Accept what you can’t change and control it and commit to improve everything you can enrich and change it in your life. The purpose of ACT is attaining psychological flexibility. ACT has six core processes: Contacting the present moment; Defusion of thoughts; Acceptance; Values; Commitment and Self as a context. This protocol takes around two months to run. It has eight sessions. In fact the intervention aims at improving the quality of life of diabetes  patients to cope with their disease toward having an active life. This program lays emphasis on medical issues along with psychological matters. Intervention 2: Intervention group: Lifestyle intervention for promoting health. In fact this protocol is a medical approach for diabetes. It emphasizes on self-care behaviors like blood sugar tests, walking, mild exercise and diet. In this course patients will learn about risks and disease resulting from diabetes and will learn how to prevent them. This program comprises six sessions taking three weeks. This approach lays little emphasis on psychological variables. Intervention 3: Control group: None intervention, only as evidence 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Total research results will be published in scientific journals

When:
The documentation and research results are likely to be published in 2018-2019

To whom:
The full research document will be available to Semnan faculty of Psychology. Research results will be available to researchers as an article and book

Conditions:
Using the results with the number and type of community and the research sample as well as the intervention can be used.

Where to obtain:
Faculty of Psychology and Educational Sciences of Semnan University.
Information and Documentation Center of Iran (IranDoc)
Or sending a message to researcher : n.soltanian@semnan.ac.ir   or n.soltanian@gmail.com

How to obtain:
Visiting the Irandoc center or Semnan University Library
Or one week after sending email to the writer

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Soltanian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.4, 9 laleh, 35 metrieh laleh, Marzdaran blvd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461874373</zip>
        <telephone>+98 21 4422 1959</telephone>
        <email>n.soltanian@semnan.ac.ir</email>
        <affiliation>Faculty of Psychology and Education of Semnan university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Eshagh Rahimian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdishahr, Education and Psychology faculty of Semnan university</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3564111156</zip>
        <telephone>+98 23 3362 4250</telephone>
        <email>i_rahimian@semnan.ac.ir</email>
        <affiliation>The university of Semnan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Type 2 diabetes patients
lack of getting psychological treatment since a  year ago</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Type 1 diabetes patients
Patients with Psychological disorders and Physical problems culminating in diabetes</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>Behavior</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acceptance and commitment therapy (ACT). The name of ACT stemming from one of its main message: Accept what you can’t change and control it and commit to improve everything you can enrich and change it in your life. The purpose of ACT is attaining psychological flexibility. ACT has six core processes: Contacting the present moment; Defusion of thoughts; Acceptance; Values; Commitment and Self as a context. This protocol takes around two months to run. It has eight sessions. In fact the intervention aims at improving the quality of life of diabetes  patients to cope with their disease toward having an active life. This program lays emphasis on medical issues along with psychological matters.</i_keyword>
      <i_keyword>Intervention group: Lifestyle intervention for promoting health. In fact this protocol is a medical approach for diabetes. It emphasizes on self-care behaviors like blood sugar tests, walking, mild exercise and diet. In this course patients will learn about risks and disease resulting from diabetes and will learn how to prevent them. This program comprises six sessions taking three weeks. This approach lays little emphasis on psychological variables.</i_keyword>
      <i_keyword>Control group: None intervention, only as evidence group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disease Perception. Timepoint: Before and after of Intervention. Method of measurement: The Brief Illness Perception Questionnaire (BIPQ).</prim_outcome>
      <prim_outcome>Disease adjustment. Timepoint: Before and after of Intervention. Method of measurement: Problem Areas in Diabetes Questionnaire(PAID).</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: Before and after of Intervention. Method of measurement: Blood analysis.</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>This is a PHD Dissertation</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-14</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Science</contact_name>
        <contact_address>Mahdishahr ;Education and psychology faculty of semnan university Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
