<?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>IRCT20200108046059N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-09</date_registration>
      <primary_sponsor>Tonekabon Azad University</primary_sponsor>
      <public_title>Comparison of compassion focused therapy (CFT) and emotional schema therapy (EST) in cancer patients.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of compassion focused therapy (CFT) and emotional schema therapy (EST) on cancer related fatigue, self-care behaviors and emotional self-regulation in cancer patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45608</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization process is done using the site www.randomization.com. In order to hide the random allocation, a sealed envelope with a random sequence is used. In such way, that the number of sample volume is 45 people, the envelope is made By the person in charge of the reception center and each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes. in order to maintain the random sequence, on the outer surface of the envelopes are numbered in the same way.Finally, the letter envelopes are glued and placed in a box, respectively. According to the order of entry of eligible participants to the study, one of the envelopes is opened and the assigned group of the participant is revealed. During this period, the researcher and participants are not aware of the assignment of the experiment and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cancer patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group 1: Compassion-focused therapy group: Content of compassion-focused therapy intervention sessions: The first session. Performing a pre-test, therapeutic logic based on self-compassion and understanding compassion and self-compassion. Session 2. Patients are asked to try to identify how they think and behave towards themselves. Session 3. Use compassionate imaging skills and use soothing breathing techniques. Session 4. Using the technique of mindfulness for patients. Session 5. In this session, the technique of writing a letter of daily compassion and promoting self-compassion is done by emotional discharge. Sixth session. In this session, pathology of factors that cause fear and repulsion of patients to Self-compassion is checked. Seventh session. Teaching methods to deal with the factors of self-compassion and the use of relaxation techniques. Summarize the sessions, make final suggestions and practice, and finally perform a post-test. Intervention 2: Intervention group: Intervention group 2: Emotional schema therapy group: Session 1. Establishing a therapeutic relationship, presenting treatment logic and therapeutic goals, presenting etiology and treatment model from the emotional schema therapy approach. Session 2. Normal and difficult emotions Well done, paying attention to the patient's painful emotions and normalizing them, emotional self-awareness, emotion education and introduction, identifying and labeling emotions, distinguishing between different emotions, identifying emotions in physical and psychological state. Session 3. Self-assessment with the aim of recognizing experience Self-assessment, self-assessment to identify the level of emotional vulnerability in the individual, self-assessment to identify emotion regulation strategies, cognitive consequences of emotional reactions, physiological consequences of emotional reactions, behavioral consequences of emotional reactions and the relationship between the three. Anger excitement and ways to overcome anger. Session 4. Addressing the emotional schemas identified in the patient, verbal challenge and Socratic dialogue. Session 5. Addressing other emotional schemas identified in the patient and the verbal challenge and Socratic dialogue, teaching the technique of writing negative memories with the aim of facilitating emotional processing. Session 6. Preventing from social isolation. Avoidance, problem-solving strategy training, interpersonal skills training (dialogue, assertiveness and conflict resolution), introductory introduction to the concept of emotion acceptance and accreditation. Seventh session. Helping patients to generate and challenge emotions, identify assessments Mistakes and their effects on emotional states. Session 8. Introducing the types of negative beliefs about emotions and challenging them, identifying miscalculations and their effects on emotional states. Ninth session. Identifying the extent and method of using inhibition strategies And examining its emotional consequences, training to express emotion, exposure, training in emotional release and relaxation. Session 10. Discussion about the severity of schemas, before and after exposure, addressing the patient's remnant. Session 11. Review sessions and practice learned skills. Session 12. Work on treatment plan (recurrence prevention) , Planning for remedial sessions, homework, commitment to continuous use of treatment exercises. Intervention 3: Control group:Control group: do not receive any 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>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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farinaz Tabibzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8 ,Alley 27, Sheikh Tappeh Ave., Urmia town</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5719935751</zip>
        <telephone>+98 44 3343 8535</telephone>
        <email>tabibzadeh_f@yahoo.com</email>
        <affiliation>Islamic Azad University of Tonekabon</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farinaz Tabibzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 8 ,Alley 27, Sheikh Tappeh Ave., Urmia town</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5719935751</zip>
        <telephone>+98 44 3343 8535</telephone>
        <email>tabibzadeh_f@yahoo.com</email>
        <affiliation>Islamic Azad University of Tonekabon</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum education at the diploma level
Conscious satisfaction with participating in research
With at least 6 months of illness and undergoing chemotherapy or radiation therapy
Minimum age 40 and maximum age 60 years
Not receiving a psychotherapy at the same time</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence of mental disorders requiring immediate treatment (such as symptoms of psychosis and substance abuse)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: Intervention group 1: Compassion-focused therapy group: Content of compassion-focused therapy intervention sessions: The first session. Performing a pre-test, therapeutic logic based on self-compassion and understanding compassion and self-compassion. Session 2. Patients are asked to try to identify how they think and behave towards themselves. Session 3. Use compassionate imaging skills and use soothing breathing techniques. Session 4. Using the technique of mindfulness for patients. Session 5. In this session, the technique of writing a letter of daily compassion and promoting self-compassion is done by emotional discharge. Sixth session. In this session, pathology of factors that cause fear and repulsion of patients to Self-compassion is checked. Seventh session. Teaching methods to deal with the factors of self-compassion and the use of relaxation techniques. Summarize the sessions, make final suggestions and practice, and finally perform a post-test.</i_keyword>
      <i_keyword>Intervention group: Intervention group 2: Emotional schema therapy group: Session 1. Establishing a therapeutic relationship, presenting treatment logic and therapeutic goals, presenting etiology and treatment model from the emotional schema therapy approach. Session 2. Normal and difficult emotions Well done, paying attention to the patient's painful emotions and normalizing them, emotional self-awareness, emotion education and introduction, identifying and labeling emotions, distinguishing between different emotions, identifying emotions in physical and psychological state. Session 3. Self-assessment with the aim of recognizing experience Self-assessment, self-assessment to identify the level of emotional vulnerability in the individual, self-assessment to identify emotion regulation strategies, cognitive consequences of emotional reactions, physiological consequences of emotional reactions, behavioral consequences of emotional reactions and the relationship between the three. Anger excitement and ways to overcome anger. Session 4. Addressing the emotional schemas identified in the patient, verbal challenge and Socratic dialogue. Session 5. Addressing other emotional schemas identified in the patient and the verbal challenge and Socratic dialogue, teaching the technique of writing negative memories with the aim of facilitating emotional processing. Session 6. Preventing from social isolation. Avoidance, problem-solving strategy training, interpersonal skills training (dialogue, assertiveness and conflict resolution), introductory introduction to the concept of emotion acceptance and accreditation. Seventh session. Helping patients to generate and challenge emotions, identify assessments Mistakes and their effects on emotional states. Session 8. Introducing the types of negative beliefs about emotions and challenging them, identifying miscalculations and their effects on emotional states. Ninth session. Identifying the extent and method of using inhibition strategies And examining its emotional consequences, training to express emotion, exposure, training in emotional release and relaxation. Session 10. Discussion about the severity of schemas, before and after exposure, addressing the patient's remnant. Session 11. Review sessions and practice learned skills. Session 12. Work on treatment plan (recurrence prevention) , Planning for remedial sessions, homework, commitment to continuous use of treatment exercises.</i_keyword>
      <i_keyword>Control group:Control group: do not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-care behaviors Score from the Esmi 2016 Questionnaire. Timepoint: Assessing self-care behaviors before and after the intervention. Method of measurement: Esmi Self-care behaviors in cancer patients questionnaire 2016.</prim_outcome>
      <prim_outcome>Cancer Fatigue Score from the Okoyama 2000 Questionnaire. Timepoint: Assessing cancer fatigue before and after the intervention. Method of measurement: Okoyama Cancer Fatigue Questionnaire 2000.</prim_outcome>
      <prim_outcome>Emotional self-regulation score of Hoffman and Kashedan 2010 questionnaire. Timepoint: Assessment of emotional self-regulation before and after the intervention. Method of measurement: Hoffman and Kashedan Emotional Self-Regulation Questionnaire 2010.</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>Tonekabon Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-26</approval_date>
        <contact_name>Ethics committee of Tonekabon Azad University</contact_name>
        <contact_address>3 km of Chalous road, Valiabad, Islamic Azad University of Tonekabon Tonekabon Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
