<?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>IRCT20201119049445N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-13</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of psychotherapy on the grief experience and quality of life in first-degree relatives of the deceased caused by COVID 19</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of interpersonal psychotherapy and compassion focused therapy on the grief experience and quality of life in first-degree relatives of the deceased caused by Covid 19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52747</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Forty eligible students will be randomly selected using convenience sampling. These people are then coded with the aid of Random Allocation software and are automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one person and that person will be randomly studied in one of the two groups, Blinding description: Due to the different content of individual psychotherapy and compassion focused therapy sessions, the intervener is aware of the two groups, but the participant will not be aware of the difference in the type of treatment due to lack of awareness of the other group. In addition, the person collecting the information and the statistician will not be aware of the two groups before the end of the treatment period.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Early signs of grief based on obtaining a score of more than 34 from the grief experience questionnaire.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Individuals in this group will be treated as interpersonal psychotherapy in 6 sessions of 45 minutes to one hour individually with the presence of a trained clinical psychologist and an assistant psychiatrist. In these sessions, the person will be trained to recognize the symptoms of depression, correct relationships (including reviewing the history of the relationship with the deceased; high intimacy or guilt due to inaction and anger of the deceased); Expanding relationships with the deceased (such as examining positive relationships with the deceased during life, the ability of clients to care for the deceased) and expanding relationships with other relatives and family (including examining the quality and quantity of previous relationships with others and role play for Verbal communication, expression of feelings and self-disclosure. Intervention 2: Second intervention group: Individuals in this group will undergo compassion-focused therapy in 6 sessions of 45 minutes to one hour individually with the presence of a trained clinical psychologist and a psychiatrist assistant. In these sessions, the person will be trained to get familiar with the general concept of self-compassion and empathy and the practice of rhythmic calming breathing; self-critical education and its types, expressing the causes of self-criticism and its consequences, preparing a diary of daily mistakes and accepting them and the skills to solve them, the exercise of self-esteem and self-worth by mentioning their positive characteristics.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hajar Salimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychiatry, Khorshid Hospital, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8145831451</zip>
        <telephone>+98 31 3222 2127</telephone>
        <email>Salimi85ha@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hajar Salimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychiatry, Khorshid Hospital, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3222 2127</telephone>
        <email>salimi85ha@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Death of a first-degree relative due to COVID19 in the last six months
Grief Experience Questionnaire (GEQ) score of &gt;34
Being consent to participate in the study
The age of &gt;18 yrs.
No major psychiatric illness (schizophrenia, bipolar, obsessive-compulsive disorder, personality disorders)
Drug use disorder based on an interview with a psychiatric assistant</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to attend treatment sessions for more than two consecutive sessions
Exacerbation of symptoms and the need for psychiatric hospitalization</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: Individuals in this group will be treated as interpersonal psychotherapy in 6 sessions of 45 minutes to one hour individually with the presence of a trained clinical psychologist and an assistant psychiatrist. In these sessions, the person will be trained to recognize the symptoms of depression, correct relationships (including reviewing the history of the relationship with the deceased; high intimacy or guilt due to inaction and anger of the deceased); Expanding relationships with the deceased (such as examining positive relationships with the deceased during life, the ability of clients to care for the deceased) and expanding relationships with other relatives and family (including examining the quality and quantity of previous relationships with others and role play for Verbal communication, expression of feelings and self-disclosure.</i_keyword>
      <i_keyword>Second intervention group: Individuals in this group will undergo compassion-focused therapy in 6 sessions of 45 minutes to one hour individually with the presence of a trained clinical psychologist and a psychiatrist assistant. In these sessions, the person will be trained to get familiar with the general concept of self-compassion and empathy and the practice of rhythmic calming breathing; self-critical education and its types, expressing the causes of self-criticism and its consequences, preparing a diary of daily mistakes and accepting them and the skills to solve them, the exercise of self-esteem and self-worth by mentioning their positive characteristics.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Grief score. Timepoint: Before and 4 weeks after the intervention. Method of measurement: Grief Experience Questionnaire.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before and 4 weeks after the intervention. Method of measurement: World Health Organization (WHO) Quality of Life Questionnaire - Short Form.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-20</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib street, Azadi square. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
