<?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>IRCT20181224042100N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-27</date_registration>
      <primary_sponsor>private organization</primary_sponsor>
      <public_title>The efficacy of cognitive-behavioral therapy based on Rumination  on depression, anxiety and hostility in cardiac patients</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of cognitive-behavioral therapy based on Rumination  on depression, anxiety and hostility in patients undergoing cardiac rehabilitation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36370</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After having the entry criteria, one number  was assigned to each person, and the numbers were assigned to three groups of intervention, rehabilitation and control according to the random numbers table.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: cardiovascular. Condition 2: depression. Condition 3: Anxiety. Condition 4: hostility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will receive 12 sessions of cognitive-behavioral behavioral therapy based on  Rumination   for one session per week. The protocol has been devised to treat depression and And focuses on changing the rumination of patients. Intervention 2: Intervention group: The rehabilitation group will receive 40 sessions of  rehabilitation program weekly in 3 sessions. Intervention 3: Control group: The control group will be selected from the waiting list and will not receive any 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 The sharing of data extracted from the study has not been reported to the participating patients</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rasoul mohammadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>10th Alley, Resalat street</address>
        <city>Shahindezh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981944451</zip>
        <telephone>+98 44 4632 1250</telephone>
        <email>rasoul.2828@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasoul Mohammadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>10th Alley, Resalat street</address>
        <city>shahindezh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5981944451</zip>
        <telephone>+98 44 4632 1250</telephone>
        <email>Rasoul.2828@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Open heart surgery following coronary heart disease
Ability to participate in the rehabilitation program and doing assignments with a diagnosis of cardiologist and rehabilitation specialist
A mild or moderate score in the questionnaire (5 upwards at PHQ-9, 8 up on BAI, and 40 up at BPAQ)
Have reading and writing skills
No other physical illness that limits attendance at meetings
No change in psychiatric medications from one month before intervention
No history of receiving psychotherapy before intervention
Age 40 to 70 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having cognitive disorders such as Alzheimer's and dementia
having severe mental disorder (Personality disorders, Psychotic disorders and Dissociatives disorders)
Thyroid Problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I51.6</hc_code>
      <hc_code>F32</hc_code>
      <hc_code>F41.1</hc_code>
      <hc_code>R45.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cardiovascular disease, unspecified</hc_keyword>
      <hc_keyword>In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reduction of energy, and decrease in activity.</hc_keyword>
      <hc_keyword>Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstance</hc_keyword>
      <hc_keyword>signs and symptoms constituting part of a mental disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will receive 12 sessions of cognitive-behavioral behavioral therapy based on  Rumination   for one session per week. The protocol has been devised to treat depression and And focuses on changing the rumination of patients.</i_keyword>
      <i_keyword>Intervention group: The rehabilitation group will receive 40 sessions of  rehabilitation program weekly in 3 sessions</i_keyword>
      <i_keyword>Control group: The control group will be selected from the waiting list and will not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Pre-test, Post-test, after 2 month. Method of measurement: Beck depression questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Pre-test, Post-test, after 2 month. Method of measurement: Beck Anxiety questionnaire.</prim_outcome>
      <prim_outcome>Hostility. Timepoint: Pre-test, Post-test, after 2 month. Method of measurement: The Aggression Questionnaire- AQ.</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>private organization</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-18</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Eraby street,  Student Blvd, Velenjk, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
