<?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>IRCT20180704040333N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-29</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Cognitive-Behavioral Therapy on Social Adjustment and Self-esteem in Thalassemic Patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Cognitive-Behavioral Therapy on Social Adjustment and Self-esteem in Thalassemic Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32467</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Since the number of patients in the age group over 15 years old who referred to thalassemia clinic was 106, all patients were enrolled by census method and then divided into two intervention and control groups using simple random sampling. The samples were divided into two groups according to the gender variable (± 2). In other words, the first sample was randomly assigned to one of the two intervention groups or control group using the lottery and the subsequent samples were assigned to each group according to the matching variables and the random conditions. , Blinding description: The intervention group is randomly selected from among 106 participants, and the control group remains unaware of the study of what study and where it is done.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Thalassemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The cognitive-behavioral group therapy group was evaluated in addition to receiving routine care with Bell's social adjustment questionnaire and Rosenberg self-esteem questionnaire. Then, 8 sessions of 90 minutes and one week of cognitive-behavioral therapy were performed for them. One Month after the completion of group training sessions are evaluated using the mentioned questionnaires. Intervention 2: Control group: Control group: The group only received routine care. Before the intervention group begins cognitive-behavioral therapy, a social and self-esteem Rosenberg questionnaire is used to evaluate and, during the course of this intervention, no intervention for this non- There is no routine care and after a month, the questionnaires are evaluated by this 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:
Potential data can be shared after unidentifiable individuals

When:
Potential data can be shared after unidentifiable individuals

To whom:
Start the month access period after printing the results

Conditions:
Researchers working in academia and academia

Where to obtain:
The data is sent through an official request and by e-mail

How to obtain:
The data is sent through an official request and by e-mail

Comments:
The data is sent through an official request and by e-mail</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Hasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of the Axis Ofhaft Bagh Alavi, Kerman University of Medical Sciences</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>m.hasanii6660@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Hasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of The Axis OfhaftBagh Alavi, Kerman University of Medical Sciences</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913555</zip>
        <telephone>+98 34 3132 5700</telephone>
        <email>m.hasanii6660@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Group over 15 years old
Have at least reading and writing skills</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having mental disorder confirmed
Failure to complete the questionnaire for any reason or defect in completing the questionnaire
Having more than two absences</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D56.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Beta thalassemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The cognitive-behavioral group therapy group was evaluated in addition to receiving routine care with Bell's social adjustment questionnaire and Rosenberg self-esteem questionnaire. Then, 8 sessions of 90 minutes and one week of cognitive-behavioral therapy were performed for them. One Month after the completion of group training sessions are evaluated using the mentioned questionnaires.</i_keyword>
      <i_keyword>Control group: Control group: The group only received routine care. Before the intervention group begins cognitive-behavioral therapy, a social and self-esteem Rosenberg questionnaire is used to evaluate and, during the course of this intervention, no intervention for this non- There is no routine care and after a month, the questionnaires are evaluated by this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1- Social Adjustment:It means a person's compromise with the social environment that this adaptation can be created by adapting itself to the environment or changing the environment to meet the needs and achieve desirable. Timepoint: Before the intervention and 30 days later. Method of measurement: Bell Social Reconciliation Questionnaire and Rosenberg Self-Esteem Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-30</approval_date>
        <contact_name>Ethics committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Four Way Somayeh (Tahmasebabad), Beginning of Jihad Boulevard, Beginning of Ibn Sina St. Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
