<?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>IRCT20190727044345N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-17</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of some psychological therapies on psychological recovery of cardiac patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of guided subjective imaginary and acceptance and commitment based therapy on the perception of disease, resilience and emotional regulation of cardiac patients referring to the heart rehabilitation department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41119</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization is carried out using table of random at 'www.randomization.com' website in a way that the produced numbers are placed inside sealed envelopes and once patients enter the study, envelopes are assigned to them which put them in one of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cardiac disease patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Patients in acceptance and commitment-based therapy group receive 8 sessions of one-hour treatment twice a week with Sahebi treatment package for one month which includes a psychological intervention that implements acceptance and awareness along with commitment and behavior change guidelines in order to increase psychological flexibility in patients. Intervention 2: Intervention group 2: Patients in the guided subjective imaginary therapy group receive 10 sessions of one-hour treatment twice a week with Simonton package (2000) which for 40 days incorporates mental practices for mental acceptance of presence of health and occurrence of recovery in body and use of imagination to produce scenes, sounds, smells, and tastes or other senses which provide a type of purposeful view. Intervention 3: Control group: No treatment is used for this group in the study.</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:
All data can be shared after patients are made unidentifiable.

When:
Data can be accessible 6 months after results are published.

To whom:
Data will be available for researchers in universities and other scientific institutes.

Conditions:
Carrying out analysis on data is permitted.

Where to obtain:
Data can be accessible through sending an email to the corresponding author.

How to obtain:
After sending a request email to the corresponding author, data will be sent in 1 month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbasali shahabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Persian Gulf International branch, daneshgah St. Minoo Shahr.</address>
        <city>Khoramshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6437113378</zip>
        <telephone>+98 61 5337 3081</telephone>
        <email>dr.shahabi20@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Ehteshamzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Persian Gulf International branch, daneshgah St. Minoo Shahr.</address>
        <city>Khoramshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6437113378</zip>
        <telephone>+98 61 5337 3081</telephone>
        <email>ehtesham85@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having cardiac disease
Having a minimum of diploma degree</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having psychological disease
Using psychological drugs
Having mental illnesses such as epilepsy and Alzheimer's
Addiction to drugs and alcohol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z50.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cardiac rehabilitation</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Patients in acceptance and commitment-based therapy group receive 8 sessions of one-hour treatment twice a week with Sahebi treatment package for one month which includes a psychological intervention that implements acceptance and awareness along with commitment and behavior change guidelines in order to increase psychological flexibility in patients.</i_keyword>
      <i_keyword>Intervention group 2: Patients in the guided subjective imaginary therapy group receive 10 sessions of one-hour treatment twice a week with Simonton package (2000) which for 40 days incorporates mental practices for mental acceptance of presence of health and occurrence of recovery in body and use of imagination to produce scenes, sounds, smells, and tastes or other senses which provide a type of purposeful view.</i_keyword>
      <i_keyword>Control group: No treatment is used for this group in the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patients resilience. Timepoint: Before and after intervention (pre and post test) and also in the follow up stage one month after intervention. Method of measurement: Conner-Davidson Resilience Scale.</prim_outcome>
      <prim_outcome>Perception of disease. Timepoint: Before and after intervention (pre and post test) and also in the follow up stage one month after intervention. Method of measurement: Disease perception questionnaire.</prim_outcome>
      <prim_outcome>Cognitive emotional regulation. Timepoint: Before and after intervention (pre and post test) and also in the follow up stage one month after intervention. Method of measurement: Cognitive emotional regulation strategies questionnaire.</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>2019-07-16</approval_date>
        <contact_name>Ethics committee of Azad University Of Ahvaz</contact_name>
        <contact_address>Azad University Of Ahvaz, Farhang Shahr, Golestan highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
