<?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>IRCT20201118049430N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of psychocho therapy dialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>: Comparison of Effectiveness of Meta cognitive Therapy and Acceptance and commitment Therapy(ACT) on Depression&amp; Post  Traumatic Growth &amp;Blood presher in Hemodialysis patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52515</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Among the individuals, we write the numbers on small pieces of paper in a simple random way and place them in three groups, two intervention groups and one control group by drawing lots.</study_design>
      <phase>3</phase>
      <hc_freetext>Kidney dialysis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In order to observe the principles of ethics, the control group will receive educational content based on metacognitive therapy approach and treatment based on acceptance and commitment after the intervention process in the experimental group in the form of educational booklets. Intervention 2: Intervention group1: Acceptance and commitment therapy that uses the processes of acceptance, mental focus, commitment, and behavioral change processes to create flexibility.Acceptance and commitment therapy based on the theoretical foundations of treatment (Izadi and Abedi, 2014) will be performed in 8 sessions of 90 minutes.                    The first session establishes a therapeutic relationship, acquaintance and general explanation of the therapeutic approach, concluding a therapeutic contract, psychological training, discussing experiences and evaluating them, efficiency as a measure, creating creative frustration of the therapist based on acceptance and commitment. The client should give up feeling better and thinking differently.                                                                              The second session examines patients' problems from an ACT perspective (extracting the experience of avoidance, integration, and individual values, and that control is the problem, not the solution). Creative frustration refers to abandoning behaviors or strategies that the client's experience has shown to be ineffective.                                        The third session expresses control as a problem, clarifying the inefficiency of controlling negative events using metaphors, introducing tendency as another response, engaging in purposeful actions (ie, general and desirable directions of life that are verbally set).                         Session 4: Applying Cognitive Fault Techniques (One of the less invasive ways of presenting fault techniques is to introduce thoughts as thoughts or products of the mind. See as thoughts: The purpose of breaking is not all thoughts, but the breaking of those thoughts that cause problems when they are considered reality.The fourth session is the observation of the self as the context of the "self" and the attachment in which events are experienced, but at the same time distinct from those events (weakening of self-concept and self-expression as an observer, showing separation between oneself, experiences Internal and Behavior) Continuous non-judgmental contact with psychological and environmental events, as they are.                 Session 5 Application of mental techniques, modeling exit from the mind, learning to experience inner experiences as a process.                                Session 6 :Identifying patients' life values and measuring values based on their importance in life, showing the dangers of focusing on results, discovering practical life values.                                                               Session 7: Determining patterns of action commensurate with values (the step-by-step process of creating a complete and integrated life, based on one's deepest desires and aspirations to use metaphors), planning for a commitment to pursuing values.                                                                        The eighth session :summarizes the concepts explored during the sessions, asking patients to explain their achievements in treatment and their plan for survival. Intervention 3: Intervention group2: : Enabling the patient to interact with their thoughts differently and to develop flexible metacognitive control and awareness, and to prevent processing through worry and rumination and threat review.Cognitive therapy derived from the theoretical foundations of treatment (Malihi Al-Dhakerini, 2016, Lena Jelink et al., 2016) will be performed in 8 sessions of 60 minutes.                                                               The first session of establishing a therapeutic relationship, familiarity and general explanation of the therapeutic approach, concluding a treatment contract, familiarity with depressive disorder and mental refinement (identifying negative points), over-generalization (using the word all and nothing) and changing views and correcting cognitive assessment.The second session of conceptualizing depression based on metacognitive model, examining memory and concentration, practicing attention training technique, presenting homework and discussing its importance in the treatment process.                                                                                      Session 3 Homework Review, Introduction to Dictatorship Technique / Phrase "Must" Analyze Profit and Loss Strict Criteria, Devaluing Positive Points (Expecting Negative Feedback, Rejecting Positive Feedback), Thinking Black and White, Finding the Right Balance, Homework Presentation.                                                                                                   Session 4: Reviewing members' homework, identifying values (observable behaviors, invisible states), strategies for living with values (identifying positive points), practicing self-esteem enhancement techniques, and homework.                                                                                                        Fifth session of homework review, zoom in and out, document style (for negative event and positive event), homework presentation.                          Sixth session of homework review, discussion about the importance of rumination in the continuation of the disorder and postponement of mental rumination and its practice, practice of relaxation search technique and breathing exercises, relaxation exercises,.withdrawal and use of strategies to break withdrawal and rumination Provide homework.  Session 7 Presenting a summary of sessions, hasty conclusions, mind reading, catastrophic prediction, reviewing possible outcomes, and re-evaluating probabilities.                                                                                 Session 8: Understanding emotions, reasoning emotion, understanding non-verbal cues, examining emotions and practicing identifying it and presenting homework, performing a relapse prevention program (identifying the factors that will cause recurrence and ways to deal with it).</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:
Information about the main outcome can be shared.

When:
After printing and publishing

To whom:
Researchers of prestigious universities and scientific institutes.

Conditions:
Similar and complementary studies

Where to obtain:
Samira Haddadi   shaddadi657@gmail.com

How to obtain:
Communication via email, sending research and scientific documents of the applicant, after confirmation, information will be available.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Haddadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit5,No. 27,13 West St,Rajai Shahr,Karaj</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3148953378</zip>
        <telephone>+98 26 3444 8412</telephone>
        <email>shaddadi657@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saied Malihi Alzackerini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Psychology,the intersection of Moazen and Esteghlal Boulevards,The end of Rajai Shahr,Karaj,Iran</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3418 2367</telephone>
        <email>saied.malihi@kiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 30 years
At least 3 months have passed  since they started dialysis</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to enter into cooperation
Do not have informed written consent
No severe mental disorders
Existence of  verbal,hearing and dementia problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y84.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Kidney dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In order to observe the principles of ethics, the control group will receive educational content based on metacognitive therapy approach and treatment based on acceptance and commitment after the intervention process in the experimental group in the form of educational booklets.</i_keyword>
      <i_keyword>Intervention group1: Acceptance and commitment therapy that uses the processes of acceptance, mental focus, commitment, and behavioral change processes to create flexibility.Acceptance and commitment therapy based on the theoretical foundations of treatment (Izadi and Abedi, 2014) will be performed in 8 sessions of 90 minutes.                    The first session establishes a therapeutic relationship, acquaintance and general explanation of the therapeutic approach, concluding a therapeutic contract, psychological training, discussing experiences and evaluating them, efficiency as a measure, creating creative frustration of the therapist based on acceptance and commitment. The client should give up feeling better and thinking differently.                                                                              The second session examines patients' problems from an ACT perspective (extracting the experience of avoidance, integration, and individual values, and that control is the problem, not the solution). Creative frustration refers to abandoning behaviors or strategies that the client's experience has shown to be ineffective.                                        The third session expresses control as a problem, clarifying the inefficiency of controlling negative events using metaphors, introducing tendency as another response, engaging in purposeful actions (ie, general and desirable directions of life that are verbally set).                         Session 4: Applying Cognitive Fault Techniques (One of the less invasive ways of presenting fault techniques is to introduce thoughts as thoughts or products of the mind. See as thoughts: The purpose of breaking is not all thoughts, but the breaking of those thoughts that cause problems when they are considered reality.The fourth session is the observation of the self as the context of the "self" and the attachment in which events are experienced, but at the same time distinct from those events (weakening of self-concept and self-expression as an observer, showing separation between oneself, experiences Internal and Behavior) Continuous non-judgmental contact with psychological and environmental events, as they are.                 Session 5 Application of mental techniques, modeling exit from the mind, learning to experience inner experiences as a process.                                Session 6 :Identifying patients' life values and measuring values based on their importance in life, showing the dangers of focusing on results, discovering practical life values.                                                               Session 7: Determining patterns of action commensurate with values (the step-by-step process of creating a complete and integrated life, based on one's deepest desires and aspirations to use metaphors), planning for a commitment to pursuing values.                                                                        The eighth session :summarizes the concepts explored during the sessions, asking patients to explain their achievements in treatment and their plan for survival.</i_keyword>
      <i_keyword>Intervention group2: : Enabling the patient to interact with their thoughts differently and to develop flexible metacognitive control and awareness, and to prevent processing through worry and rumination and threat review.Cognitive therapy derived from the theoretical foundations of treatment (Malihi Al-Dhakerini, 2016, Lena Jelink et al., 2016) will be performed in 8 sessions of 60 minutes.                                                               The first session of establishing a therapeutic relationship, familiarity and general explanation of the therapeutic approach, concluding a treatment contract, familiarity with depressive disorder and mental refinement (identifying negative points), over-generalization (using the word all and nothing) and changing views and correcting cognitive assessment.The second session of conceptualizing depression based on metacognitive model, examining memory and concentration, practicing attention training technique, presenting homework and discussing its importance in the treatment process.                                                                                      Session 3 Homework Review, Introduction to Dictatorship Technique / Phrase "Must" Analyze Profit and Loss Strict Criteria, Devaluing Positive Points (Expecting Negative Feedback, Rejecting Positive Feedback), Thinking Black and White, Finding the Right Balance, Homework Presentation.                                                                                                   Session 4: Reviewing members' homework, identifying values (observable behaviors, invisible states), strategies for living with values (identifying positive points), practicing self-esteem enhancement techniques, and homework.                                                                                                        Fifth session of homework review, zoom in and out, document style (for negative event and positive event), homework presentation.                          Sixth session of homework review, discussion about the importance of rumination in the continuation of the disorder and postponement of mental rumination and its practice, practice of relaxation search technique and breathing exercises, relaxation exercises,.withdrawal and use of strategies to break withdrawal and rumination Provide homework.  Session 7 Presenting a summary of sessions, hasty conclusions, mind reading, catastrophic prediction, reviewing possible outcomes, and re-evaluating probabilities.                                                                                 Session 8: Understanding emotions, reasoning emotion, understanding non-verbal cues, examining emotions and practicing identifying it and presenting homework, performing a relapse prevention program (identifying the factors that will cause recurrence and ways to deal with it).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention, immediately after the intervention and three months after the intervention. Method of measurement: Beck Depression Inventory.</prim_outcome>
      <prim_outcome>Post-traumatic growth. Timepoint: Before the intervention, immediately after the intervention and three months after the intervention. Method of measurement: Post-traumatic growth scale.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before each intervention, immediately after each intervention and three months after the intervention. Method of measurement: Hand barometer.</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>2020-11-17</approval_date>
        <contact_name>Islamic Azad University, Parand Branch</contact_name>
        <contact_address>Unit5,No. 27,13 West St,Rajai Shahr,Karaj Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
