<?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>IRCT20141108019855N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-19</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Faculty of Behavioral Sciences of Iran University of Medical Science</primary_sponsor>
      <public_title>Compassion-Focused Therapy (CFT) on Patients with Cancer</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Compassion-Focused Therapy (CFT) on psychological Sympthoms and Quality of Life on Patients with Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30175</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The final sample will be included 30 participants who will be randomly assigned to both control and intervention groups. At first, the names of all the subjects will be written  and be placed in a container, and in another there are 15 control sheets and 15 test sheets. Without naming the of individuals or groups, each name and group of containers are removed from each selection. This is repeated so that everyone is placed  in the control and intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression Disorder. Condition 2: Generalized anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients will participate in eight sessions of 2 hours of Group Therapy based on Compassion; at the first session, the group will respond to self-esteem, depression, anxiety and stress, and quality of life questionnaires. It will be performed for the group of compassion-based therapy; the first sessions, the rationale of compassion-based therapy, the concepts of compassion and compassion will be introduced; further, individuals are asked to try to think and behave towards themselves; During these meetings, some methods such as: picturing compassion of the species, relieving breathing, harmony, empathy, writing a compassionate letter, etc. Encouragement will be taught to the people themselves; in the final sessions, people will be encouraged to recognize and deal with factors that cause their fear and repulsion toward the component of compassion; at the last and second session Month after the end of the session (follow up), depression, anxiety, stress and quality of life will be re-tested. Intervention 2: Control group:The control group will not receive any psychotherapy interventions and will respond only to all the questionnaires that the testing team will answer before and after the implementation.</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:
Release in clinics and mental hospitals.

When:
Get started 6 months after printing results.

To whom:
Researchers working in academia and academia.

Conditions:
More research in this area for researchers with email requests.

Where to obtain:
Mahsa mirzakhani؛ Email: mahsa.myrzakhany@gmail.com
tel: 09122057154

How to obtain:
Access is ultimately up to one month after the request by email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahsa Mirzakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid MNo. 1, ansouri Street, Niyayesh Street, Satarkhan Avenue, School of Behavioral Sciences and Mental Health, Tehran City</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۵۶۱۳۱۱۱</zip>
        <telephone>+98 69903349</telephone>
        <email>mahsa.mirzakhani@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahsa Mirzakhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid MNo. 1, ansouri Street, Niyayesh Street, Satarkhan Avenue, School of Behavioral Sciences and Mental Health, Tehran City</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۵۶۱۳۱۱۱</zip>
        <telephone>+98 69903349</telephone>
        <email>mahsa.mirzakhani@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1) the age range of 18 years.
2) the possession of a minimum diploma.
3) the occurrence of any type of cancer based on a physician's diagnosis.
4) those who, according to the results of a pathological test, have at least two months The definitive history of their diagnosis passes.
5) Patients undergoing drug and chemotherapy.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>mental retardation.
Patients are not at the end stages of cancer.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.2</hc_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, severe without psychotic features</hc_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients will participate in eight sessions of 2 hours of Group Therapy based on Compassion; at the first session, the group will respond to self-esteem, depression, anxiety and stress, and quality of life questionnaires. It will be performed for the group of compassion-based therapy; the first sessions, the rationale of compassion-based therapy, the concepts of compassion and compassion will be introduced; further, individuals are asked to try to think and behave towards themselves; During these meetings, some methods such as: picturing compassion of the species, relieving breathing, harmony, empathy, writing a compassionate letter, etc. Encouragement will be taught to the people themselves; in the final sessions, people will be encouraged to recognize and deal with factors that cause their fear and repulsion toward the component of compassion; at the last and second session Month after the end of the session (follow up), depression, anxiety, stress and quality of life will be re-tested.</i_keyword>
      <i_keyword>Control group:The control group will not receive any psychotherapy interventions and will respond only to all the questionnaires that the testing team will answer before and after the implementation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: pretest.posttest (at the end of 8 session). Method of measurement: DASS  inventory.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: pretest.posttest (at the end of 8 session). Method of measurement: DASS  inventory.</prim_outcome>
      <prim_outcome>Stress. Timepoint: pretest.posttest (at the end of 8 session). Method of measurement: DASS  inventory.</prim_outcome>
      <prim_outcome>Compassion Focused Therapy. Timepoint: pretest.posttest (at the end of 8 session), 8 weeks following end of the treatments. Method of measurement: Self-Compassion Scale.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: pretest.posttest (at the end of 8 session). Method of measurement: Quality of life inventory.</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>Vice Chancellor for Research of Faculty of Behavioral Sciences of Iran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-21</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahid MNo. 1, ansouri Street, Niyayesh Street, Satarkhan Avenue, School of Behavioral Sciences and Mental Health, Tehran City Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
