<?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>IRCT20230401057794N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-21</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Psychotherapy on diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of acceptance based emotion regulation on diabetes control scale on type 2 diabetes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69392</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: خیر, Randomization description: The randomization method of the current research is restricted randomization, and random allocation rule is used to select people in the intervention groups. At first, codes were assigned to all three groups, and then by lottery, the order of the groups was determined in order of  acceptance based emotion regulation, acceptance and commitment, and the waiting list. In the next step, the code was assigned to the sample people. Then each code was drawn by lottery and assigned to the groups based on the order they were placed until the codes were finished. 20 people were in the acceptance based emotion regulation  group, 20 people were in the acceptance and commitment group, and 20 people were in the waiting list.</study_design>
      <phase>N/A</phase>
      <hc_freetext>type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The acceptance based emotion regulation The therapeutic intervention takes place during 14 sessions, and during these sessions, the role of emotions, their function, how to identify and properly express them, strategies for regulating unpleasant emotions and the role of values in giving meaning to life conditions are discussed. Each session is held once a week for 1:30. The people present in this intervention sit around each other in a room and the therapist, after introducing and teaching the points of the session, leads them to joint discussion and group exercises. The content of each session is prepared with the help of educational aids such as PowerPoint and session summaries and is provided to them. Intervention 2: Control group 1: acceptance and commitment group/ The therapeutic intervention takes place during 12 sessions and during these sessions the role of values, adherence to them and acceptance of inevitable aspects of life are discussed. The content of each session is detailed in the protocol of this treatment. Each session is held once a week for 1:30. The people present in this intervention sit around each other in a room and the therapist, after introducing and teaching the points of the session, leads them to joint discussion and group exercises. The content of each session is prepared with the help of educational aids such as PowerPoint and session summaries and is provided to them. Intervention 3: Control group 2: Treatment as usual/This group receive drug treatment and routine education of the Diabetes Association.</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:
Main result

When:
6 month after publication

To whom:
University

Conditions:
For research

Where to obtain:
elnazhajati@yahoo.com

How to obtain:
elnazhajati@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Banafshe Gharraee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Satarkhan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86701</telephone>
        <email>b.gharraee@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Banafshe Gharraee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Satarkhan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 86701</telephone>
        <email>b.gharraee@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis if type 2 diabetes by endocrinologist
Age between 35-65
Treatment under endocrinologist
Medical report</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>New drug treatment with the start of intervention
Not suffering from other type of diabetes
Sever psychiatric disorder
Substance abuse disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with other specified complications</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: The acceptance based emotion regulation The therapeutic intervention takes place during 14 sessions, and during these sessions, the role of emotions, their function, how to identify and properly express them, strategies for regulating unpleasant emotions and the role of values in giving meaning to life conditions are discussed. Each session is held once a week for 1:30. The people present in this intervention sit around each other in a room and the therapist, after introducing and teaching the points of the session, leads them to joint discussion and group exercises. The content of each session is prepared with the help of educational aids such as PowerPoint and session summaries and is provided to them.</i_keyword>
      <i_keyword>Control group 1: acceptance and commitment group/ The therapeutic intervention takes place during 12 sessions and during these sessions the role of values, adherence to them and acceptance of inevitable aspects of life are discussed. The content of each session is detailed in the protocol of this treatment. Each session is held once a week for 1:30. The people present in this intervention sit around each other in a room and the therapist, after introducing and teaching the points of the session, leads them to joint discussion and group exercises. The content of each session is prepared with the help of educational aids such as PowerPoint and session summaries and is provided to them.</i_keyword>
      <i_keyword>Control group 2: Treatment as usual/This group receive drug treatment and routine education of the Diabetes Association.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Pre test, post test, follow up. Method of measurement: The adult of diabetes-dependent quality of life.</prim_outcome>
      <prim_outcome>Self-care. Timepoint: Pre test, post test, follow up. Method of measurement: Summary of diabetes self-care activities.</prim_outcome>
      <prim_outcome>HbA1c. Timepoint: Pre test, post test, follow up. Method of measurement: Blood Test.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-16</approval_date>
        <contact_name>ethics committee if iran university</contact_name>
        <contact_address>satarkhan tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
