<?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>IRCT20180428039458N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-04</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Integrative Behavioral Couple therapy, Narrative Couple therapy and Couple Schema Therapy in Coronary Artery Patients &amp; their Spouses.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Integrative Behavioral Couple Therapy (IBCT), Narrative Couple Therapy (NCT) and Couple Schema Therapy (ST-C) on Quality of Life, Affective Capital, Depression, Stress, Hope and   Marital Intimacy among Coronary Artery Patients &amp; their Spouses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60308</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Couples (about 80 couples) were purposefully selected based on the inclusion criteria and then selected by simple random method (lottery: according to the sampling framework among the community, a sample of the desired volume was selected from among the listed individuals (based on inclusion criteria) and then by lot (writing names on lottery cards and random selection of names) are divided into four groups (three intervention groups and one control group), Blinding description: Participants were blind to grouping and reporting.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Integrative behavioral couple therapy: Integrative behavioral couple therapy sessions are in the form of 8 90-minute tissue-based sessions and help couples to increase their satisfaction and adjustment. This approach includes three intervention strategies (empathetic unity, allied neutrality, and tolerance) designed to increase acceptance between couples. These sessions will be based on the integrated behavioral therapy protocol of Christensen and Jacobsen (1998). Intervention 2: Intervention group: Couple narrative therapy: Couple narrative therapy sessions in the present study in the form of 8 90-minute sessions based on using a set of methods for understanding people's stories, deconstructing and rewriting these stories by the individual and with the help of the therapist . These sessions will be based Friedman and Combs treatment protocol(2008). Intervention 3: Intervention group: Couple Schema Therapy: Couple schema therapy sessions in the present study in the form of 8 90-minute sessions based on the correction and modification of early maladaptive schemas that play a role in creating and perpetuating couples' communication problems. These sessions will be based on the guidelines of Young (2003) and Simeone-Difrancesco, Roeder, Stevens (2015). Intervention 4: Control group:  The control group (waiting list) does 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The total data can be potentially shared after making it "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, Email: 6maryam@gmail.com

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>Khorasgan Azad University; Daneshgah Blvd; Arqavanieh Blvd; Jey street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81551-39998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>6maryam5@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Golparvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasgan Azad University; Daneshgah Blvd; Arqavanieh Blvd; Jey street</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81551-39998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>drmgolparvar@hotmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of cardiovascular disease
Being in the age range of 25 to 65 years old
diploma education at least</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Using psychiatric drugs
Acute or chronic mental disorders (approved by a clinical psychologist)
Using concomitant psychological therapies</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>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Integrative behavioral couple therapy: Integrative behavioral couple therapy sessions are in the form of 8 90-minute tissue-based sessions and help couples to increase their satisfaction and adjustment. This approach includes three intervention strategies (empathetic unity, allied neutrality, and tolerance) designed to increase acceptance between couples. These sessions will be based on the integrated behavioral therapy protocol of Christensen and Jacobsen (1998).</i_keyword>
      <i_keyword>Intervention group: Couple narrative therapy: Couple narrative therapy sessions in the present study in the form of 8 90-minute sessions based on using a set of methods for understanding people's stories, deconstructing and rewriting these stories by the individual and with the help of the therapist . These sessions will be based Friedman and Combs treatment protocol(2008).</i_keyword>
      <i_keyword>Intervention group: Couple Schema Therapy: Couple schema therapy sessions in the present study in the form of 8 90-minute sessions based on the correction and modification of early maladaptive schemas that play a role in creating and perpetuating couples' communication problems. These sessions will be based on the guidelines of Young (2003) and Simeone-Difrancesco, Roeder, Stevens (2015).</i_keyword>
      <i_keyword>Control group:  The control group (waiting list) does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention). Method of measurement: Beck Depression Inventory.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention). Method of measurement: Ware &amp; Sherbourne Inventory.</prim_outcome>
      <prim_outcome>Affective capital. Timepoint: Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention. Method of measurement: Golpavar Affective capital  Inventory.</prim_outcome>
      <prim_outcome>Hope. Timepoint: Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention. Method of measurement: Snyder hope Inventory.</prim_outcome>
      <prim_outcome>Marital intimacy. Timepoint: Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention. Method of measurement: Thompson &amp; Walker Inventory.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention. Method of measurement: Leung, Lam &amp; Chan Inventory.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-22</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University - Isfahan (Khorasgan) Branch</contact_name>
        <contact_address>Unit 1; Mahestan Building; Motahary Street; Felezi bridge; Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
