<?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>IRCT20230219057460N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-02</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Acceptance and Commitment Therapy On reducing grief symptoms, coronavirus anxiety and improving the quality of life</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Acceptance and Commitment Therapy On reducing grief symptoms, coronavirus anxiety and improving the quality of life</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68759</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be simple randomization. The randomization unit is individual. At first, the names of the participants will be collected as a set of numbers, without any particular pattern or order, and completely randomly generated in advance, and these numbers will be used to categorize different groups, in such a way that the even numbers in the group Intervention and individual numbers will be placed in the control group.Even numbers in the intervention group and individual numbers will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronavirus anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental group will receive 10 sessions of 2 hours (120 minutes) during 10 weekly sessions. Session 1 :Assessment and Evaluation: recognize and identify the type of grief, comorbidity and Definition of Grief, Stages of Grief, Grief resolved to unresolved grief Understanding Acceptance and Commitment Therapy, the obligation to accept and carry out assignments and participate in group and individual Session 2: Pain, suffering, struggle and avoidance, Acceptance, Review coping strategies and control Creative Hopelessness, Explain and discuss the impact of control• explain the willingness Session 3: discuss the nature of automatic thoughts Creative Hopelessness, Exercise prayer, Do not think of exercise (chocolate donut metaphor)How the mind works, chatter, machine words, pop up mind Acceptance thoughts, versus Avoidance. Session 4: Talk about the experience of emotions, Emotional appeals emotions Bdaynd, creative Hopelessness (control)Happiness trap, Marriage Practices, Relationships between emotions, Talk about anger Presentation given mindfulness training (as a substitute for emotional control), practice of mindful breathing, Acceptance of emotions versus avoidance (rejection)  Session 5-7: mindfulness training completed, Exercise: Walk quietly, Practice: tea, Practice: mindful Eating Introduction to Cognitive defusion Practice: The word "milk "The pronunciation of poetry readings It is very slow to tell With different voices to tell Bad News Radio. Session 8-10: Complete discussion, willingness, Introduction values, evaluate the values, the selection of values, Targets, Commitment, completion of discussion and follow up. Intervention 2: Control group: No Treatment.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Masjedi Arani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839-63113</zip>
        <telephone>+98 21 23871</telephone>
        <email>a.masjediarani@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Bakhtiyari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839-63113</zip>
        <telephone>+98 21 23871</telephone>
        <email>maryam_.bakhtiyari@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Bereaved people who have lost a loved one and at least 3 months have passed since their death
Be 18 years old or older</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of concurrent mental disorders such as bipolar disorders and related disorders, schizophrenia spectrum disorders and other psychotic disorders, addictive disorders and substance-related disorders
Organic brain disorder based on the report of the family and the patient herself</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</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: The experimental group will receive 10 sessions of 2 hours (120 minutes) during 10 weekly sessions. Session 1 :Assessment and Evaluation: recognize and identify the type of grief, comorbidity and Definition of Grief, Stages of Grief, Grief resolved to unresolved grief Understanding Acceptance and Commitment Therapy, the obligation to accept and carry out assignments and participate in group and individual Session 2: Pain, suffering, struggle and avoidance, Acceptance, Review coping strategies and control Creative Hopelessness, Explain and discuss the impact of control• explain the willingness Session 3: discuss the nature of automatic thoughts Creative Hopelessness, Exercise prayer, Do not think of exercise (chocolate donut metaphor)How the mind works, chatter, machine words, pop up mind Acceptance thoughts, versus Avoidance. Session 4: Talk about the experience of emotions, Emotional appeals emotions Bdaynd, creative Hopelessness (control)Happiness trap, Marriage Practices, Relationships between emotions, Talk about anger Presentation given mindfulness training (as a substitute for emotional control), practice of mindful breathing, Acceptance of emotions versus avoidance (rejection)  Session 5-7: mindfulness training completed, Exercise: Walk quietly, Practice: tea, Practice: mindful Eating Introduction to Cognitive defusion Practice: The word "milk "The pronunciation of poetry readings It is very slow to tell With different voices to tell Bad News Radio. Session 8-10: Complete discussion, willingness, Introduction values, evaluate the values, the selection of values, Targets, Commitment, completion of discussion and follow up</i_keyword>
      <i_keyword>Control group: No Treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Corona anxiety score in the Corona Anxiety Questionnaire. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention. Method of measurement: Corona Anxiety Questionnaire Alipour et al (2019).</prim_outcome>
      <prim_outcome>Grief score on the Complex Grief Scale (ICG). Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention. Method of measurement: Grief Questionnaire of Prigerson and Maciejewski  (1995).</prim_outcome>
      <prim_outcome>Quality of life score in the short form of the World Health Organization Quality of Life Scale (WHOQOL-BRIEF). Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention. Method of measurement: Purba et al. quality of life questionnaire(2018).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-03</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
