<?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>IRCT20180428039458N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Comparison of the Effectiveness of Happiness training with Cognitive- Behavioral Therapy(CBT) in Coronary  Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of the Effectiveness of Happiness training with Cognitive- Behavioral Therapy(CBT) on Depression, Happiness, Optimism, General health and C-reactive protein(CRP) in coronary patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30893</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Present study was a randomized pilot trial to compare the effectiveness of two interventions of happiness training and cognitive-behavioral therapy among patients with heart disease who were randomly selected from patients referring to the Rehabilitation Center of the Isfahan Cardiovascular Research Institute. Participants were then randomized to the experimental or control condition using concealed cards with group assignment listed that were only accessed by study staff following completion of baseline assessments, Blinding description: Participants were blinded about the grouping and assignments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: received Lyubomirsky happiness training program (2008) for 8 sessions of 90 minutes (once a week). Intervention 2: The second intervention groups: received cognitive-behavioral therapy (CBT) for 8 sessions of 90 minutes (once a week). Intervention 3: Attention control group: received  routine medical education for cardiac patients for 8 sessions of 90 minutes (once a week).</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:
The total potential data can be shared after being "unidentifiable"

When:
Start the access period 6 months after publishing of the results

To whom:
It will be accessible for everyone

Conditions:
There will be no specific condition

Where to obtain:
Maryam Baghooli Kermani

How to obtain:
There will not be any specific process, we will be responsive after receiving an email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Baghooli Kermani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2nd Kilometer of Mobarakeh Road- Boroujen</address>
        <city>Boroujen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8871898555</zip>
        <telephone>+98 38 3422 3812</telephone>
        <email>6maryam5@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholam Reza Nikrahan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2nd Kilometer of Mobarakeh Road-Boroujen</address>
        <city>Boroujen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8871898555</zip>
        <telephone>+98 38 3422 3812</telephone>
        <email>rezanikrahan@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Documented diagnosis of coronary artery disease
Agreement to participate in study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receive anti-inflammatory drugs
Receive any other psychological intervention or treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: received Lyubomirsky happiness training program (2008) for 8 sessions of 90 minutes (once a week).</i_keyword>
      <i_keyword>The second intervention groups: received cognitive-behavioral therapy (CBT) for 8 sessions of 90 minutes (once a week).</i_keyword>
      <i_keyword>Attention control group: received  routine medical education for cardiac patients for 8 sessions of 90 minutes (once a week).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>C-reactive protein (CRP). Timepoint: Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the intervention). Method of measurement: hs-CRP Kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the intervention). Method of measurement: Beck Depression Inventory.</sec_outcome>
      <sec_outcome>Happiness. Timepoint: Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the post-test). Method of measurement: Oxford Happiness Scale.</sec_outcome>
      <sec_outcome>Optimism. Timepoint: Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the post-test). Method of measurement: Life Orientation Test(LOT).</sec_outcome>
      <sec_outcome>General health. Timepoint: Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the post-test). Method of measurement: Goldberg General Health Questionnaire(GHQ).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Isfahan Cardiovascular Research Center</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
      <source_name>Isfahan Cardiovascular Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-12</approval_date>
        <contact_name>National research Ethics Committee of Islamic Azad University -branch Isfahan (Khorasgan)</contact_name>
        <contact_address>University Blvd, Arghavanieh, The East Jey St., Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
