<?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>IRCT20190717044252N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Cognitive Behavioral Therapy (CBT) program on depression and sleep quality</public_title>
      <acronym>CBT</acronym>
      <scientific_title>The effect of Nurse-led Cognitive Behavioral Therapy (CBT) program on depression and sleep quality in patients undergoing open heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40963</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The highlight of the above study is the implementation of a cognitive behavioral therapy program by a trained Nursing Specialist, Randomization description: For random assignment, at first, each of the final participants will be given a sample of one to 84 (sample size), then using the software R and the sample command, 42 of the code are selected from 84 codes as the intervention group, and the remaining numbers represent The code will be the control group, Blinding description: The days of referral in the intervention group for counseling are different with the days of referral of patients in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Sleep Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Cognitive behavioral intervention group or CBT. Intervention group includes those who have mild to moderate degrees of post-operative depression based on the tools used and will receive CBT protocol in addition to routine care at the treatment center. The CBT protocol will consist of 10 to 12 one-hour weekly sessions, when the patient is indicated, by a trained nurse and in an appropriate pre-embedded location. There will be interactions, discussions, assignments and feedback. Weekly focal points are as follows: Week One: Establish a therapeutic relationship, set a meeting schedule, identify problems objectively, and set treatment goals. Week 2: Increasing patient knowledge, activating behavioral functions, and problem solving techniques. Week 3-4: Identifying automatic thoughts, improving problem-solving skills, reducing ineffective cognitive processes on behavior. Week 5-6: Reconstructing automatic thoughts, identifying abilities, and learning self-treatment techniques. Weeks 7 to 8: Continue self-treatment and relapse prevention. Week 9 - 10: Training to improve self-care skills in the field of illness and to increase acceptable activity according to disease conditions, end Intervention and discontinuation of therapeutic relationship. In this intervention, two sessions were considered as floating to complete the questionnaire or if needed for a longer session and need to continue the intervention. Intervention 2: Control group:The control group includes those who receive only routine post-cardiac care routine care. Routine and routine care, including routine medical and nursing follow-up after cardiac surgery and psychiatric evaluation of a patient by a psychiatrist only if necessary, and requesting a psychiatric consultation by the ICU cardiologist.cognitive 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Navab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery., Dr Mirkhani St., Tohid Square.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>e_navab100@hotmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham Navab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery., Dr Mirkhani St., Tohid Square.,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>e_navab100@hotmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to attend counseling sessions
Minimum diploma education
Age between 20 and 65 years
Stay in shiraz
Full vigilance and ability to speak Persian
Physical and mental fitness required to answer questions
Not attending other training courses at the same time
Not having a specific psychiatric condition before surgery
Having Depression After Heart Surgery
Having a sleep disorder after heart surgery</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The unwillingness of the subject to participate or continue to participate in the research
Cases of other diseases, including malignancies or autoimmune disorders
Facing specific mental crises before surgery
Treated with sedative drugs before surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.1</hc_code>
      <hc_code>F51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Moderate depressive episode</hc_keyword>
      <hc_keyword>Nonorganic sleep disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Cognitive behavioral intervention group or CBT. Intervention group includes those who have mild to moderate degrees of post-operative depression based on the tools used and will receive CBT protocol in addition to routine care at the treatment center. The CBT protocol will consist of 10 to 12 one-hour weekly sessions, when the patient is indicated, by a trained nurse and in an appropriate pre-embedded location. There will be interactions, discussions, assignments and feedback. Weekly focal points are as follows: Week One: Establish a therapeutic relationship, set a meeting schedule, identify problems objectively, and set treatment goals. Week 2: Increasing patient knowledge, activating behavioral functions, and problem solving techniques. Week 3-4: Identifying automatic thoughts, improving problem-solving skills, reducing ineffective cognitive processes on behavior. Week 5-6: Reconstructing automatic thoughts, identifying abilities, and learning self-treatment techniques. Weeks 7 to 8: Continue self-treatment and relapse prevention. Week 9 - 10: Training to improve self-care skills in the field of illness and to increase acceptable activity according to disease conditions, end Intervention and discontinuation of therapeutic relationship. In this intervention, two sessions were considered as floating to complete the questionnaire or if needed for a longer session and need to continue the intervention.</i_keyword>
      <i_keyword>Control group:The control group includes those who receive only routine post-cardiac care routine care. Routine and routine care, including routine medical and nursing follow-up after cardiac surgery and psychiatric evaluation of a patient by a psychiatrist only if necessary, and requesting a psychiatric consultation by the ICU cardiologist.cognitive intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression Score in Beck Questionnaire. Timepoint: The beginning of the study and the end of the intervention. Method of measurement: Beck Depression Inventory.</prim_outcome>
      <prim_outcome>Sleep disorder. Timepoint: The beginning of the study and the end of the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-19</approval_date>
        <contact_name>The Ethics Committee of the Faculty of Nursing and Midwifery and Rehabilitation of Tehran University</contact_name>
        <contact_address>No. 29, 11 Ave., Shahidan Gerami Ave., Farhang Shahr Ave., Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
