<?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>IRCT20170522034081N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-01</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>the effectiveness of logotherapy and mindfulness in patients with coronary heart disease</public_title>
      <acronym></acronym>
      <scientific_title>Compare the effectiveness of logotherapy and mindfulness- based stress reduction therapy (MBSR) with routtine treatments  on Stress, Anxiety, Depression and Quality of life in patients with coronary heart disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33301</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization;
Individual unit;
A computer-generated random sequence number by SAS software;
Build sequences based on numbers generated by SAS software and one of the people unrelated to the Research Project, Blinding description: Until the end of the clinical trial; participants, researchers, outcome assessor, statistical analyst, therapists and monitoring committee will not be aware of the allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: undergoes mindfulness-based stress reduction therapy (MBSR) treatment protocol in 8 sessions of 90 minutes.The content of the sessions is as follows:Session 1: Introducing the participants, giving explanations about anxiety and depression and its effect on heart disease, raisin eating practice, breathing-focused meditation practice, body check exercise. Session 2: Body check exercise, inviting participants to discuss experiences of mindfulness exercises, examining barriers, examining the characteristics of mindfulness such as non-judgment or abandonment, practicing sitting meditation with a focus on breathing. Session 3: Practice seeing or hearing briefly, sitting meditation on concentration and body senses, three-minute breathing space, practicing conscious body movements. Session 4: practicing sitting meditation with a focus on breathing, discussing stress and the individual's usual reactions to difficult situations and alternative attitudes and reactions, conscious walking. Session 5: practicing sitting meditation with a focus on breathing, discussing the acceptance of the reality of the present situation as you are, practicing the second series of conscious body movements. Session 6: Three-minute breathing space, discussing thoughts that are often not real. Session 7: Practicing sitting meditation and open awareness, discussing the best way to take care of yourself, reviewing pleasant versus unpleasant daily activities, and learning to plan for pleasant activities, practicing love and kindness meditation. Session 8: Body checks exercise, review of trainings, evaluation of education, providing more resources. Intervention 2: Second intervention group: under the group semantic therapy protocol of James C. Cronbach (1973) in 8 sessions of 90 minutes.These goals will be pursued in all sessions:1. Helping participants to clarify values that are particularly meaningful to them. 2. Set reasonable goals. 3. Ensuring that participants' goals achieve meaningful personal values.4. Practical planning to achieve goals. 5. Identify the strengths and weaknesses of the participants that affect the achievement of their goals. 6. Consider strengths and weaknesses in planning to achieve goals that achieve participants' values. Intervention 3: The control group receives the usual treatments of the Cardiac Rehabilitation Clinic, which is Cognitive-Behavioral Therapy (CBT). Cognitive-behavioral therapy will be in twelve sessions of 90 minutes. The structure of the sessions is such that in the first session, evaluation and diagnostic interview will be performed and the second to twelfth sessions will have the same structure as follows. The structure of the first session of treatment: setting the agenda and talking about its logic, examining the patient's mood, a brief overview of the patient's problems and, if necessary, their brief revision, identifying problems objectively and setting treatment goals, teaching the patient cognitive model, review patient expectations about treatment, patient education about their disorder, assigning homework, session summary, and feedback. The structure of the second session of treatment onwards includes a brief review of the previous week and the patient's mood, bridging the previous session, setting the agenda, reviewing the patient's homework, discussing the topics set in the agenda and assigning homework for next week, summarizing, and Feedback.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mozhgan Hemmati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiac Rehabilitation Center; Afshar hospital; Jomhouri blvd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8917945556</zip>
        <telephone>+98 35 3525 8354</telephone>
        <email>mozhganhemmaty@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mohamad Reza Vafaeenasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiac Rehabilitation Center; Afshar hospital; Jomhouri blvd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8917945556</zip>
        <telephone>+98 35 3525 8354</telephone>
        <email>rzvafaee@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age less than 75 years
Have the least reading and writing skills
Informed consent
Type of treatment PCI
EF above 40</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cardiac valve disease
Cardiac arrhythmia
Chronic obstructive pulmonary disease (COPD)
Having diabetes complications
Being dialysis
convulsion
Cerebrovascular accident (CVA)
High risk In terms of cardiac rehabailitation
Having chronic underlying illnesses
Not having Heart failure disease (HF)
Not having Implantable Cardioverter Defibrillator (ICD)
Lack of pharmacotherapy and non-prescriptive therapies for psychiatric illnesses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I27</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other pulmonary heart diseases</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>Intervention group 1: undergoes mindfulness-based stress reduction therapy (MBSR) treatment protocol in 8 sessions of 90 minutes.The content of the sessions is as follows:Session 1: Introducing the participants, giving explanations about anxiety and depression and its effect on heart disease, raisin eating practice, breathing-focused meditation practice, body check exercise. Session 2: Body check exercise, inviting participants to discuss experiences of mindfulness exercises, examining barriers, examining the characteristics of mindfulness such as non-judgment or abandonment, practicing sitting meditation with a focus on breathing. Session 3: Practice seeing or hearing briefly, sitting meditation on concentration and body senses, three-minute breathing space, practicing conscious body movements. Session 4: practicing sitting meditation with a focus on breathing, discussing stress and the individual's usual reactions to difficult situations and alternative attitudes and reactions, conscious walking. Session 5: practicing sitting meditation with a focus on breathing, discussing the acceptance of the reality of the present situation as you are, practicing the second series of conscious body movements. Session 6: Three-minute breathing space, discussing thoughts that are often not real. Session 7: Practicing sitting meditation and open awareness, discussing the best way to take care of yourself, reviewing pleasant versus unpleasant daily activities, and learning to plan for pleasant activities, practicing love and kindness meditation. Session 8: Body checks exercise, review of trainings, evaluation of education, providing more resources.</i_keyword>
      <i_keyword>Second intervention group: under the group semantic therapy protocol of James C. Cronbach (1973) in 8 sessions of 90 minutes.These goals will be pursued in all sessions:1. Helping participants to clarify values that are particularly meaningful to them. 2. Set reasonable goals. 3. Ensuring that participants' goals achieve meaningful personal values.4. Practical planning to achieve goals. 5. Identify the strengths and weaknesses of the participants that affect the achievement of their goals. 6. Consider strengths and weaknesses in planning to achieve goals that achieve participants' values.</i_keyword>
      <i_keyword>The control group receives the usual treatments of the Cardiac Rehabilitation Clinic, which is Cognitive-Behavioral Therapy (CBT). Cognitive-behavioral therapy will be in twelve sessions of 90 minutes. The structure of the sessions is such that in the first session, evaluation and diagnostic interview will be performed and the second to twelfth sessions will have the same structure as follows. The structure of the first session of treatment: setting the agenda and talking about its logic, examining the patient's mood, a brief overview of the patient's problems and, if necessary, their brief revision, identifying problems objectively and setting treatment goals, teaching the patient cognitive model, review patient expectations about treatment, patient education about their disorder, assigning homework, session summary, and feedback. The structure of the second session of treatment onwards includes a brief review of the previous week and the patient's mood, bridging the previous session, setting the agenda, reviewing the patient's homework, discussing the topics set in the agenda and assigning homework for next week, summarizing, and Feedback.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and after intervention. Method of measurement: Sf-36 Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>Stress score. Timepoint: Before and after intervention. Method of measurement: SSD Questionnaire.</prim_outcome>
      <prim_outcome>Depression score. Timepoint: Before and after intervention. Method of measurement: Beck Questionnaire depression.</prim_outcome>
      <prim_outcome>Anxiety score. Timepoint: Before and after intervention. Method of measurement: Beck Questionnaire anxiety.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-14</approval_date>
        <contact_name>Ethics Committee Of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Shahid Sadoughi Blvd., Bahonar Square Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
