<?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>IRCT20160924029954N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-25</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of cognitive-behavioral based education in comparison with conventional education on the depression , adjustment and self-care behaviors in patients with depression and heart failure hospitalized in Zahedan instructional hospitals in 2018</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive-behavioral based education in comparison with conventional education on the depression , adjustment and self-care behaviors in patients with depression and heart failure hospitalized in Zahedan instructional hospitals in 2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32404</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: does not have, Randomization description: First of all, from patients with heart failure diagnosis based on the criteria for entering the study, a sample is selected according to the sampling method. We ask patients to choose a sheet from a bag contains 80 sheets. 40 sheets in blue represent the usual training group, 40 sheets in red represent the cognitive-behavioral group. People who select the red card will be in the cognitive-behavioral group and those who choose the blue tab will be placed in the regular training group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: heart failure patients. Condition 2: depressive disorder.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group ": Cognitive-behavioral group, 5 separate sessions take an average of 60 minutes on the patient's bedside. Contents of the sessions: Session 1: Life with heart failure: Knowledge transfer about heart failure, signs and symptoms of symptoms, care and treatment. Session 2: Depression and Cardiac Failure: Includes a summary of the contents of the previous session, knowledge transfer about the identification of depression, the relationship between depression and heart failure, identifying concerns about depression and how to treat depression. Session 3: Behavioral Activation: Provide a brief overview of the contents of the previous session, the relationship of behavior, thoughts and creations, identifying the automatic thoughts, behavioral assessment, behavioral training, and preparing a favorite behavior table. Session 4: Solving Collaboration Problems: Provide a brief overview of the contents of the previous session, identify and understand the patient from problems, problem-solving training and problem-solving in a constructive manner, problem solving practice. Session 5: Spiritual Evolution and Aggregation: Specifies a summary of the content of the previous session, cognitive rehabilitation, self-esteem, a checklist for dealing with potential obstacles. Intervention 2: "Control group": routine training,4 separate sessions are held on the patient's bedside for an average of 30 minutes. The sessions include: Session 1: definitions of deficiency, causes and symptoms and symptoms of the disease. Session 2: A summary of the contents of the previous session, the importance of self-care, diet, weight control, rest and activity, measurement of urine volume. Session 3: Provide a brief overview of the contents of the meeting, monitoring signs of worsening and necessary measures, vaccination, alcohol and tobacco restrictions, the importance of taking medication. Session 4: Provide a brief overview of the content of the previous session, short video presentation, questions and answers on the topics discussed and the conclusions.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Participants information is confidential</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reyhane Khayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zahedan Hermand street2</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9813797396</zip>
        <telephone>+98 215922023</telephone>
        <email>khayati.rkh@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Navidian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Field Of Fame - Zahedan Nursing And Midwifery Faculty</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816913396</zip>
        <telephone>+98 54 3344 2482</telephone>
        <email>alinavidian@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of heart failure (Grades 2 and 3) based on cardiology and recorded in patient records
Not being infected with other known psychiatric illnesses
- Obtain a score of at least 21 from the Beck Depression Test and confirm the depression in the psychiatric examination.
- Resident of the city and accessible for follow up.
- Awareness and full awareness and ability to communicate.
-No addiction and substance abuse
-No addiction and substance abuse
-Delay at least 6 months of illness
No lack of communication</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>- Critical illness, death, or any unplanned event during the study;-
Clearance earlier than a week. Absence or absence of more than one treatment session.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50</hc_code>
      <hc_code>F32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart failure</hc_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group ": Cognitive-behavioral group, 5 separate sessions take an average of 60 minutes on the patient's bedside. Contents of the sessions: Session 1: Life with heart failure: Knowledge transfer about heart failure, signs and symptoms of symptoms, care and treatment. Session 2: Depression and Cardiac Failure: Includes a summary of the contents of the previous session, knowledge transfer about the identification of depression, the relationship between depression and heart failure, identifying concerns about depression and how to treat depression. Session 3: Behavioral Activation: Provide a brief overview of the contents of the previous session, the relationship of behavior, thoughts and creations, identifying the automatic thoughts, behavioral assessment, behavioral training, and preparing a favorite behavior table. Session 4: Solving Collaboration Problems: Provide a brief overview of the contents of the previous session, identify and understand the patient from problems, problem-solving training and problem-solving in a constructive manner, problem solving practice. Session 5: Spiritual Evolution and Aggregation: Specifies a summary of the content of the previous session, cognitive rehabilitation, self-esteem, a checklist for dealing with potential obstacles.</i_keyword>
      <i_keyword>"Control group": routine training,4 separate sessions are held on the patient's bedside for an average of 30 minutes. The sessions include: Session 1: definitions of deficiency, causes and symptoms and symptoms of the disease. Session 2: A summary of the contents of the previous session, the importance of self-care, diet, weight control, rest and activity, measurement of urine volume. Session 3: Provide a brief overview of the contents of the meeting, monitoring signs of worsening and necessary measures, vaccination, alcohol and tobacco restrictions, the importance of taking medication. Session 4: Provide a brief overview of the content of the previous session, short video presentation, questions and answers on the topics discussed and the conclusions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"The percentage of people who have a backseat score of over 21.". Timepoint: "Measuring depression at the beginning of the study and 30 days after intervention". Method of measurement: Beck Depression Inventory.</prim_outcome>
      <prim_outcome>"Compliance Score in the Compliance with the Disease Questionnaire". Timepoint: "Measuring compliance at the beginning of the study and 30 days after intervention". Method of measurement: "PAIS Compliance Inventory".</prim_outcome>
      <prim_outcome>"Self-care score in self-care questionnaire in cardiac patients". Timepoint: "Self-care measurements before and 30 days after intervention". Method of measurement: Self-care Questionnaire for Heart Patients.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-01</approval_date>
        <contact_name>Ethics Committee Of Zahedan University Of Medical Sciences &amp; Health Services</contact_name>
        <contact_address>Administrative Complex Of Zahedan Medical Science Campus، Persian Gulf Blvd، Dr. Hesabi Square، Zahedan Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
