<?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>IRCT20190202042582N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Three Treatments (mindfulness combination with memory specificity training (MB-MEST)) with  mindfulness &amp;  memory specificity training (MEST) on Mental and Physical Health of Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>A Comparative Study of the Effectiveness (mindfulness combination with memory specificity training (MB-MEST) with  mindfulness &amp;  memory specificity training (MEST) on Anxiety, Depression and Mental Well-being, Physical Symptoms, and Cognitive Emotion Regulation Strategies in Hemodialysis Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40208</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  The structure of the training sessions is based on a Mindfulness-Based Cognitive Therapy Package integrated with the MEST Proprietary Memory Training Package, designed and tested by researchers (Nouri Fard, Neshat Dost and Sajjadian, 2017). Which includes 10 sessions of training and therapy in 10 weeks and each session is 2 hours. In this therapeutic package, patients undergoing hemodialysis are undergoing training in a mind-boggling training program with a specialist memory training program, In this intervention, the program utilizes the integration of the protocol of treatment of mindfulness and the treatment protocol of personalized memory education, while treating it challenging the memory, thoughts and irrational beliefs of chronic disease with depression and anxiety. Emotional regimes associated with unresectable renal therapy, positive thoughts, substitute negative thoughts. Intervention 2: Intervention group: The structure of treatment sessions based on the Mindfulness Cognitive Therapy Package is an eight-week treatment for up to 12 participants and includes a combination of cognitive meditation exercises.The agenda of the sessions is based on the protocol for treatment of mindfulness therapy (Segal et al., 2002).This treatment includes eight sessions of group training that lasts once a week and lasts for two hours.In this tutorial, patients learn how to interact in a way that is different from their negative thoughts and feelings, and focus on changing their beliefs and thoughts.They also learn how to shape their thoughts, change their habits, rumors, their thoughts, and their negative emotions, become aware of them, and see them in a wider perspective. Intervention 3: Intervention group: Participants in the intervention group included 12 hemodialysis patients, trained with specialist memory education package designed by Maxwell et al. (2015), including 6 sessions. The goal is to retrieve autobiographical memories. After completing the training, the subjects responded to the questionnaires. Intervention 4: Control group: The control group did not participate in any kind of 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marziyeh Noorifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Blvd., Arghavaniyeh,. East Gay Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>m_nuorifard57@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Taher Neshat Doost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University,. Azadi Square</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3793 5500</telephone>
        <email>h.neshat@edu.ui.ac.ir</email>
        <affiliation>The University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to Participate and Continue Therapy Sessions
Diploma and Higher Education
Not Taking Part in any Other Psychological Treatment</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Taking Medications that Reduce Consciousness
Trauma or Brain Damage
Lack of Motivation to Participate in Meetings</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Major depr</hc_code>
      <hc_code>Generalize</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>F32.1</hc_keyword>
      <hc_keyword>F41.1</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  The structure of the training sessions is based on a Mindfulness-Based Cognitive Therapy Package integrated with the MEST Proprietary Memory Training Package, designed and tested by researchers (Nouri Fard, Neshat Dost and Sajjadian, 2017). Which includes 10 sessions of training and therapy in 10 weeks and each session is 2 hours. In this therapeutic package, patients undergoing hemodialysis are undergoing training in a mind-boggling training program with a specialist memory training program, In this intervention, the program utilizes the integration of the protocol of treatment of mindfulness and the treatment protocol of personalized memory education, while treating it challenging the memory, thoughts and irrational beliefs of chronic disease with depression and anxiety. Emotional regimes associated with unresectable renal therapy, positive thoughts, substitute negative thoughts.</i_keyword>
      <i_keyword>Intervention group: The structure of treatment sessions based on the Mindfulness Cognitive Therapy Package is an eight-week treatment for up to 12 participants and includes a combination of cognitive meditation exercises.The agenda of the sessions is based on the protocol for treatment of mindfulness therapy (Segal et al., 2002).This treatment includes eight sessions of group training that lasts once a week and lasts for two hours.In this tutorial, patients learn how to interact in a way that is different from their negative thoughts and feelings, and focus on changing their beliefs and thoughts.They also learn how to shape their thoughts, change their habits, rumors, their thoughts, and their negative emotions, become aware of them, and see them in a wider perspective</i_keyword>
      <i_keyword>Intervention group: Participants in the intervention group included 12 hemodialysis patients, trained with specialist memory education package designed by Maxwell et al. (2015), including 6 sessions. The goal is to retrieve autobiographical memories. After completing the training, the subjects responded to the questionnaires.</i_keyword>
      <i_keyword>Control group: The control group did not participate in any kind of intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression Score in Beck Questionnaire. Timepoint: The end of the intervention. Method of measurement: BAI - Beck Depression Inventory.</prim_outcome>
      <prim_outcome>Anxiety Score in Beck Questionnaire. Timepoint: The end of the intervention. Method of measurement: BAI - Beck Anxiety Inventory.</prim_outcome>
      <prim_outcome>Psychological well-being score in psychological well-being questionnaire. Timepoint: The end of the intervention. Method of measurement: psychological well-being questionnaire.</prim_outcome>
      <prim_outcome>Emotion Score in Cognitive Emotion Regulation Questionnaire (CERQ)Questionnaire. Timepoint: The end of the intervention. Method of measurement: Cognitive Emotion Regulation Questionnaire (CERQ).</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>2019-02-20</approval_date>
        <contact_name>Ethics committee of Islamic Azad University-Isfahan(Khorasgan)Branch</contact_name>
        <contact_address>University Blvd.,East Gay Ave., Arghavaniyeh Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
