<?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>IRCT20200206046394N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-16</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of Effectiveness of Cognitive Behavioral Therapy and Dialectic Behavioral Therapy on Medication Adherence in Patients Undergoing Hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Effectiveness of Cognitive Behavioral Therapy and Dialectic Behavioral Therapy on Medication Adherence in Patients Undergoing Hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46099</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Due to the spread of the new corona virus in Iran, it is not possible to determine the exact time of onset and end of the choose a patient, so there is a possibility of a slight change in these times, Randomization description: Sixty patients are selected in a convenient way, by providing informed consent form to the hemodialysis patients, and then patients with poor and moderate medication adherence score in the Morisky Medication Adherence Scale will be selected and we will randomly place eligible individuals into three groups (two experimental and one control). The method of assigning individuals in control and intervention groups is simple randomization and randomization tool is the lottery.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Kidney failure.</hc_freetext>
      <i_freetext>Intervention 1: Control group: They do not receive any intervention. Intervention 2: Cognitive-behavioral intervention will be performed by embezzlement from Farquhar. Its steps include: The first step is to identify the patient's problem and the reason for the patient's non-compliance through a face-to-face interview. (Questions such as: Why don't you follow your medication regimen? What is the biggest obstacle to your adherence to the medication regimen? ...). The second stage of the intervention is to create commitment and self-confidence in the patient in order to correct the wrong behavior. At this stage, with the help of the researcher, the patient recognizes the problems and obstacles related to his non-commitment, and at this time a contract is created between the patient and the researcher to improve compliance, which is through increasing the patient's motivation to change behavior. By saying positive affirmations, the researcher tries to increase the patient's self-confidence and create interest in changing the patient's misbehavior. At the end of the session, the patient is also asked to write down all the things he or she does during the next week and the next session as a daily report in order to follow the medication regimen throughout the day. In the second week of the third stage of the intervention, all the patient's daily reports on adherence to the medication regimen and the patient's self-reported statements are reviewed and summarized. In this way, according to the patients 'report, the obstacles and factors affecting the patients' adherence to the medication regimen are examined. In the fourth stage, the intervention of the designed program is provided to the patients face to face. This program includes training on following the medication regimen of hemodialysis patients (in the form of an educational pamphlet) and also provides patients with the necessary information about the implementation of the designed program. In the fourth week, the fifth and sixth stages of the intervention are performed, and in fact in this stage, it is evaluated to what extent the designed program is effective in improving patient compliance. It seems that this behavior is maintained through the use of motivational sentences. These steps will be followed by a structured face-to-face motivational interview in four 30-40 minute sessions. Intervention 3: Second intervention group: Dialectical behavioral therapy interventions are performed under the auspices of Marsha Linhan (1993), Mito McKay et al. (2007), and Melanie Gordon, Sheets (2009). Its steps include: The first session is familiar with the concept of mindfulness and three mental states (logical mind, emotional mind and mindfulness). The second session includes teaching two categories of skills to achieve mindfulness: the first category of "what" skills (including observation, description and description) and the second category of "how" skills (including non-judgmental, self-conscious and efficient self-awareness). to act, to act upon, surgery). The third step involves teaching strategies to distract and distract the mind with acceptance skills (activities, participation, comparisons, distractions, thoughts, and feelings). The fourth stage involves self-relaxation training with five senses. The fifth step involves teaching the pattern of identifying emotions and labeling them, which leads to increased emotion control. The sixth session includes training on creating positive emotional experiences by creating short-term positive emotional experiences. The seventh session includes situations for effective communication and interpersonal efficiency (proportionality of one's desires with the desires of others; the ratio of desires to needs). The eighth session includes effective communication goals and interpersonal efficiency (achieving goals in a situation and coping with resistance and conflict.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arman Mehrazin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, Block 319, Parking 3, Neighborhood A3., Esteghlal St</address>
        <city>Fooladshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>84918-36489</zip>
        <telephone>+98 31 5263 0259</telephone>
        <email>armanmehrazinn@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arman Mehrazin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, Block 319, Parking 3, Neighborhood A3, Esteghlal St</address>
        <city>Fooladshahr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>84918-36489</zip>
        <telephone>+98 31 5263 0259</telephone>
        <email>armanmehrazinn@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum 18 years and maximum 60 years
Minimum diploma literacy
Ability to complete the questionnaire
Willingness to participate in the study
Hemodialysis twice or more per week
Lack of mental disability or known severe mental illness or functional (bone muscular) disability
Fully alert
Listening and speaking ability</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>With known severe mental illness or functional disability (muscle, bone)
Drug addiction
Being hospitalized in the intensive care unit
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>V15.81 (Z9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonadherence to Medical Treatment (726)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: They do not receive any intervention.</i_keyword>
      <i_keyword>Cognitive-behavioral intervention will be performed by embezzlement from Farquhar. Its steps include: The first step is to identify the patient's problem and the reason for the patient's non-compliance through a face-to-face interview. (Questions such as: Why don't you follow your medication regimen? What is the biggest obstacle to your adherence to the medication regimen? ...). The second stage of the intervention is to create commitment and self-confidence in the patient in order to correct the wrong behavior. At this stage, with the help of the researcher, the patient recognizes the problems and obstacles related to his non-commitment, and at this time a contract is created between the patient and the researcher to improve compliance, which is through increasing the patient's motivation to change behavior. By saying positive affirmations, the researcher tries to increase the patient's self-confidence and create interest in changing the patient's misbehavior. At the end of the session, the patient is also asked to write down all the things he or she does during the next week and the next session as a daily report in order to follow the medication regimen throughout the day. In the second week of the third stage of the intervention, all the patient's daily reports on adherence to the medication regimen and the patient's self-reported statements are reviewed and summarized. In this way, according to the patients 'report, the obstacles and factors affecting the patients' adherence to the medication regimen are examined. In the fourth stage, the intervention of the designed program is provided to the patients face to face. This program includes training on following the medication regimen of hemodialysis patients (in the form of an educational pamphlet) and also provides patients with the necessary information about the implementation of the designed program. In the fourth week, the fifth and sixth stages of the intervention are performed, and in fact in this stage, it is evaluated to what extent the designed program is effective in improving patient compliance. It seems that this behavior is maintained through the use of motivational sentences. These steps will be followed by a structured face-to-face motivational interview in four 30-40 minute sessions.</i_keyword>
      <i_keyword>Second intervention group: Dialectical behavioral therapy interventions are performed under the auspices of Marsha Linhan (1993), Mito McKay et al. (2007), and Melanie Gordon, Sheets (2009). Its steps include: The first session is familiar with the concept of mindfulness and three mental states (logical mind, emotional mind and mindfulness). The second session includes teaching two categories of skills to achieve mindfulness: the first category of "what" skills (including observation, description and description) and the second category of "how" skills (including non-judgmental, self-conscious and efficient self-awareness). to act, to act upon, surgery). The third step involves teaching strategies to distract and distract the mind with acceptance skills (activities, participation, comparisons, distractions, thoughts, and feelings). The fourth stage involves self-relaxation training with five senses. The fifth step involves teaching the pattern of identifying emotions and labeling them, which leads to increased emotion control. The sixth session includes training on creating positive emotional experiences by creating short-term positive emotional experiences. The seventh session includes situations for effective communication and interpersonal efficiency (proportionality of one's desires with the desires of others; the ratio of desires to needs). The eighth session includes effective communication goals and interpersonal efficiency (achieving goals in a situation and coping with resistance and conflict.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Medication adherence. Timepoint: Measurements of drug treatment adherence are completed before the intervention and 14 days after the start of the intervention and immediately after the intervention, and questionnaires are re-completed one month after the intervention. Method of measurement: Morisky Medication Adherence Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Accompanying depression score. Timepoint: Before and after the intervention, the questionnaires will be completed by the subjects in order to follow up on the effect of the interventions one month after the interventions. Method of measurement: Beck's second depression inventory.</sec_outcome>
      <sec_outcome>Accompanying anxiety score. Timepoint: Before and after the intervention, the questionnaires will be completed by the subjects in order to follow up on the effect of the interventions one month after the interventions. Method of measurement: Beck Anxiety Inventory.</sec_outcome>
      <sec_outcome>Medicinal beliefs of patients or medicinal beliefs of individuals. Timepoint: Before and after the intervention, the questionnaires will be completed by the subjects in order to follow up on the effect of the interventions one month after the interventions. Method of measurement: Questionnaire and drug belief tool for patients (BMQ), which higher scores indicate a stronger belief of patients in each of the subscales.</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, Khomeini Shahr Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-10</approval_date>
        <contact_name>Islamic Azad University - Isfahan Branch (Khorasgan)</contact_name>
        <contact_address>Esteghlal St., Neighborhood A3, Parking 3, Block 3 Khorasgan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
