<?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>IRCT20230309057660N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Psychological intervention and counseling to reduce symptoms of prolonged grief disorder</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive-behavioral intervention in reducing fear of COVID-19 symptoms, anxiety, depression, stress and improving the quality of life in people suffering from prolonged grief disorder due to the COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69084</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individuals who have admission criteria receive a specific code, and then a certain number of them are randomly selected using a table of random numbers. Then, a random selection is made to determine the two experimental and control groups, Blinding description: The intervention conditions in this study are such that blinding the participants to the type of intervention is not feasible. The outcome assessor will be responsible for questioning and will not be one of the intervention experts in the study, and the data analyst will not have information about the nature of the study groups' coding.</study_design>
      <phase>N/A</phase>
      <hc_freetext>prolonged grief disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: The cognitive-behavioral intervention in this study is described as follows: In the first session, the participants are greeted and the cognitive-behavioral model (A-B-C) is introduced and its relationship with the treatment of prolonged grief disorder is explained. In the second session, coping strategies for depression and anxiety and improving the quality of life in patients with prolonged grief disorder are discussed. The third session focuses on teaching logical thinking techniques. The fourth session teaches problem-solving skills. The fifth session addresses cognitive errors and coping strategies for them. The final session focuses on relapse prevention. Intervention 2: Control group: The control group received usual care during this period.</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 is "There is no further information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed salman Alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ruzbeh Hospital, South Kargar St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333795914</zip>
        <telephone>+98 21 5541 3540</telephone>
        <email>ssasi1979@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed salman Alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ruzbeh Hospital, South Kargar St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333795914</zip>
        <telephone>+98 21 5541 3540</telephone>
        <email>ssasi1979@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being within the age range of 18 to 65 years old
Diagnosis of COVID-19 in an individual and the person is in the post-treatment recovery phase and also suffers from prolonged grief disorder
Willingness to participate in the project and obtaining informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>64 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe physical problems or visible organ impairment
Patients with major depressive disorder, psychosis, or major psychiatric disorders were not included in the study and only initial drug treatments were performed for them</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: The cognitive-behavioral intervention in this study is described as follows: In the first session, the participants are greeted and the cognitive-behavioral model (A-B-C) is introduced and its relationship with the treatment of prolonged grief disorder is explained. In the second session, coping strategies for depression and anxiety and improving the quality of life in patients with prolonged grief disorder are discussed. The third session focuses on teaching logical thinking techniques. The fourth session teaches problem-solving skills. The fifth session addresses cognitive errors and coping strategies for them. The final session focuses on relapse prevention</i_keyword>
      <i_keyword>Control group: The control group received usual care during this period</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variable in this study is prolonged grief resulting from COVID-19. Timepoint: Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention. Method of measurement: Using the Structured Clinical Interview for DSM Disorders (SCID).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fear of COVID-19 Scale Score in Individuals with COVID-19-Related Prolonged Grief Disorder. Timepoint: Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention. Method of measurement: Fear of COVID-19 Scale.</sec_outcome>
      <sec_outcome>Depression scores in individuals with prolonged grief disorder due to COVID-19. Timepoint: Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention. Method of measurement: Using the Depression-Anxiety-Stress Scale (DASS-21) questionnaire.</sec_outcome>
      <sec_outcome>Quality of life score in individuals with prolonged grief disorder due to COVID-19. Timepoint: Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention. Method of measurement: Using the WHOQOL-BREF questionnaire.</sec_outcome>
      <sec_outcome>Anxiety scores in individuals with prolonged grief disorder due to COVID-19. Timepoint: Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention. Method of measurement: Using the Depression-Anxiety-Stress Scale (DASS-21) questionnaire.</sec_outcome>
      <sec_outcome>Stress scores in individuals with prolonged grief disorder due to COVID-19. Timepoint: Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention. Method of measurement: Using the Depression-Anxiety-Stress Scale (DASS-21) questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-10</approval_date>
        <contact_name>The Ethics Committee of the Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
