<?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>IRCT2014010516081N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-12</date_registration>
      <primary_sponsor>The University of Isfahan</primary_sponsor>
      <public_title>The study of the effectiveness of  happiness interventions on coronary artery patients</public_title>
      <acronym></acronym>
      <scientific_title>The study of the effectiveness of Seligman, Fordyce and Lyubomirsky happiness training programs on inflammatory markers and mental health in coronary artery patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>69</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15145</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: The happiness training programs (HTP) will plan in six sessions, each lasting 1.5 hours, on a weekly basis for 1.5 months, with weekly exercises. During each session, happiness trainer will provide the intervention manual, will present happiness strategies and techniques, and discuss the rationale for the happiness exercises and their positive impacts. &#13;
Fordyce's HTP:  W1: 1-keep busy and  be more active 2- Spend more time socializing 3- Close relationships. W2: 1-Be productive 2-Get better organized and plan things out. W3:1-Stop worrying 2-Lower your expectations and aspirations. W4: 1-Develop positive, optimistic thinking 2-Become present oriented. W5: 1-Be yourself 2-Work on a healthy personality 3-Develop an outgoing, social personality. W6: 1-Eliminate negative feelings and problems 2-Put happiness as your most important priority. Intervention 2: The happiness training programs (HTP) will plan in six sessions, each lasting 1.5 hours, on a weekly basis for 1.5 months, with weekly exercises. During each session, happiness trainer will provide the intervention manual, will present happiness strategies and techniques, and discuss the rationale for the happiness exercises and their positive impacts. &#13;
Lyubomirsky's HTP : W1: 1-Acting like a happy person 2-Savoring life's Joys 3-Practicing acts of kindness. W2: 1-Nurturing social relationships 2-physical activity. W3: 1-Cultivating optimism 2-Expressing gratitude. W4: 1-Avoiding overthinking and social comparison 2-Developing strategies for coping. W5: 1- Learning to forgive 2-Practicing religion and spirituality. W6: 1-Increasing flow experiences 2-Committing to your goals 3-Meditation. Intervention 3: The happiness training programs (HTP) will plan in six sessions, each lasting 1.5 hours, on a weekly basis for 1.5 months, with weekly exercises. During each session, happiness trainer will provide the intervention manual, will present happiness strategies and techniques, and discuss the rationale for the happiness exercises and their positive impacts.                 &#13;
Seligman's HTP: Week 1 (W1): 1-Free yourself of imprisoning determinism 2- contentment 3- Forgiving and forgetting. W2: 1-Enhancing the pleasures 2-gratification. W3: 1-Increasing optimism 2- Increasing hope. W4: 1-Your signature strengths. W5: 1 Deploy your signature strengths 2-Your partner’s strengths. W6: The meaningful life. Intervention 4: The control group will not receive any training program and will be in waiting list until the end of the study and then will receive the most effective intervention among HTPs.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Nikrahan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The university of isfahan- Hezarjarib st.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1444 2953</telephone>
        <email>nikrahan@edu.ui.ac.ir / rezanikrahan@yahoo.com</email>
        <affiliation>The university of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Nikrahan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University of Isfahan, Hzarjarib St., Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1444 2953</telephone>
        <email>nikrahan@edu.ui.ac.ir and rezanikrahan@yahoo.com</email>
        <affiliation>The University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: undergoing CABG or PCI&#13;
 Exclusion criteria : medical condition limiting ability to participate in the study; unwillingness to participate in all stages of study; antidepressant usage or being under psychotherapy; anti-inflammatory or immunologic medication usage</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The happiness training programs (HTP) will plan in six sessions, each lasting 1.5 hours, on a weekly basis for 1.5 months, with weekly exercises. During each session, happiness trainer will provide the intervention manual, will present happiness strategies and techniques, and discuss the rationale for the happiness exercises and their positive impacts. &#13;
Fordyce's HTP:  W1: 1-keep busy and  be more active 2- Spend more time socializing 3- Close relationships. W2: 1-Be productive 2-Get better organized and plan things out. W3:1-Stop worrying 2-Lower your expectations and aspirations. W4: 1-Develop positive, optimistic thinking 2-Become present oriented. W5: 1-Be yourself 2-Work on a healthy personality 3-Develop an outgoing, social personality. W6: 1-Eliminate negative feelings and problems 2-Put happiness as your most important priority.</i_keyword>
      <i_keyword>The happiness training programs (HTP) will plan in six sessions, each lasting 1.5 hours, on a weekly basis for 1.5 months, with weekly exercises. During each session, happiness trainer will provide the intervention manual, will present happiness strategies and techniques, and discuss the rationale for the happiness exercises and their positive impacts. &#13;
Lyubomirsky's HTP : W1: 1-Acting like a happy person 2-Savoring life's Joys 3-Practicing acts of kindness. W2: 1-Nurturing social relationships 2-physical activity. W3: 1-Cultivating optimism 2-Expressing gratitude. W4: 1-Avoiding overthinking and social comparison 2-Developing strategies for coping. W5: 1- Learning to forgive 2-Practicing religion and spirituality. W6: 1-Increasing flow experiences 2-Committing to your goals 3-Meditation.</i_keyword>
      <i_keyword>The happiness training programs (HTP) will plan in six sessions, each lasting 1.5 hours, on a weekly basis for 1.5 months, with weekly exercises. During each session, happiness trainer will provide the intervention manual, will present happiness strategies and techniques, and discuss the rationale for the happiness exercises and their positive impacts.                 &#13;
Seligman's HTP: Week 1 (W1): 1-Free yourself of imprisoning determinism 2- contentment 3- Forgiving and forgetting. W2: 1-Enhancing the pleasures 2-gratification. W3: 1-Increasing optimism 2- Increasing hope. W4: 1-Your signature strengths. W5: 1 Deploy your signature strengths 2-Your partner’s strengths. W6: The meaningful life.</i_keyword>
      <i_keyword>The control group will not receive any training program and will be in waiting list until the end of the study and then will receive the most effective intervention among HTPs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>CRP. Timepoint: Pretest- posttest-followup. Method of measurement: CRP Kit.</prim_outcome>
      <prim_outcome>IL-1. Timepoint: Pretest- posttest-followup. Method of measurement: IL-1 Kit.</prim_outcome>
      <prim_outcome>IL-6. Timepoint: Pretest- posttest-followup. Method of measurement: IL-6 Kit.</prim_outcome>
      <prim_outcome>Salivary cortisol. Timepoint: Pretest- posttest-followup. Method of measurement: cortisol kit.</prim_outcome>
      <prim_outcome>Happiness. Timepoint: Pretest- posttest-followup. Method of measurement: Oxford quastionnaire.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Pretest- posttest-followup. Method of measurement: BDI-II.</prim_outcome>
      <prim_outcome>Life satisfaction. Timepoint: Pretest- posttest-followup. Method of measurement: DINER SWL SCALE.</prim_outcome>
      <prim_outcome>Hope. Timepoint: Pretest- posttest-followup. Method of measurement: Snyder hope scale.</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>The University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-07-06</approval_date>
        <contact_name>The University of Isfahan</contact_name>
        <contact_address>The University of Isfahan- hezar jarib st.- Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
