<?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>IRCT20171010036693N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Study of the effectiveness of well-being therapy on coronary patients</public_title>
      <acronym></acronym>
      <scientific_title>Study of the feasibility and effectiveness of well-being therapy on psychological well-Being, optimism, positive and negative affects and depression in coronary patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27358</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: Present study was a randomized pilot trial to examine psychological wellbeing intervention among patients with heart disease who were randomly selected from patients referring to Saheb al-Zaman Hospital in Shahreza. Participants were then randomized to the psychological wellbeing intervention or the 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 blind about the grouping and assignments. Also group assignment listed were only accessed by study staff following completion of baseline assessments. Statistical analysts were also blind to the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiac patients with definite diagnosis of coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group received well-being therapy based on Ryff psychological well-being (2014) during 8 sessions (weekly, 90 minutes, for 8 weeks). Intervention 2: Control group: Attention control group received usual medical education during 8 sessions (weekly, 90 minutes, for 8 weeks).</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:
برای همه قابل دسترس خواهد بود

Conditions:
شرط خاصی وجود نخواهد داشت

Where to obtain:
لیلا اسحاقی 
eshaghi1453@gmail.com

How to obtain:
فرایند خاصی وجود نخواهد داشت صرفا از طریق ارسال ایمیل پاسخگو خواهیم بود

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Eshaghi</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>eshaghi1453@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
Minimal reading and writing skills
Agree to participate in study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Physical problems or psychological disorders that prevent participation in intervention sessions
Receive any other psychological intervention or treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group received well-being therapy based on Ryff psychological well-being (2014) during 8 sessions (weekly, 90 minutes, for 8 weeks).</i_keyword>
      <i_keyword>Control group: Attention control group received usual medical education during 8 sessions (weekly, 90 minutes, for 8 weeks).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome is the psychological well-being and feasibility of the intervention. 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: Instrument included Ryff  psychological well-being questionnaire (1993).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression, Optimism (Life Orientation), and positive and negative affects. 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: Instruments included Beck Depression Inventory (1996), Life Orientation Test (LOT, 1985), and positive and negative affects questionnaire (PANAS 1989).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-13</approval_date>
        <contact_name>islamic azad university khorasgan branch</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>
