<?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>IRCT20240602061981N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Acceptance and Commitment Therapy on Prolonged Grief Disorder</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Acceptance and Commitment Therapy on Emotion Regulation, Cognitive Fusion and Self-Compassion of People with Prolonged Grief Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77757</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>prolonged grief disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, acceptance and commitment therapy was performed. Acceptance and commitment therapy is one of the treatments of the third wave of behavioral therapy, which was introduced by Steven Hayes and his colleagues in the early 1980s and is known as ACT, and is rooted in a deep philosophy called functional contextualism, which is theoretically based on The theory is a framework of mental relations that explains how the human mind creates suffering and the useless methods of dealing with it, as well as alternative contextual approaches for these areas. This therapy focuses on the six aspects of acceptance, commitment in action, self as context, cognitive fusion, values, and presence in the present moment and seeks to improve psychological flexibility. The number of treatment sessions of this intervention can consist of 6 sessions and affect disorders such as major depressive disorder, anxiety disorders and trauma-related disorders. Intervention 2: Control group: No treatment protocol was performed in this group. In this group of people suffering from prolonged grief disorder, they completed emotion regulation, self-compassion and cognitive fusion questionnaires in the pre-test and after 8 weeks, they repeated the previous questionnaires again. In these 8 weeks, no intervention has been done on this group.</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:
Questionnaires completed by the control group and the demographic information can be shared and presented.

When:
Access can start 6 months after the results are published.

To whom:
The data is accessible only to researchers working in academic and scientific institutions.

Conditions:
People requesting study data can use the data if they want to use this documentation for future studies to compare with other disorders or other psychological variables or other therapeutic interventions. Also, their studies should have a code of ethics or if they are from an organization, there should be a necessary license.

Where to obtain:
They can through the journal in which this article is published or through email
daraeimahdiye@gmai.com to access the data.

How to obtain:
After applying through the given email, they should send their proposal and code of ethics as well as their program and wait for a response.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mahdiye daraei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qaemshahr - Shanzdeh Meter Street - Marmar Alley - Marwarid Building - 3rd floor</address>
        <city>Qaemshar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4765983551</zip>
        <telephone>+98 11 4225 1527</telephone>
        <email>daraeimahdiye@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>asghar noruzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari-Qaran Street-Qo Medical Complex-Unit 17</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4765983551</zip>
        <telephone>009891133310585</telephone>
        <email>asg.noruzi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>This includes receiving a diagnosis of long-term grief disorder based on the long-term grief questionnaire of Prigerson et al. (2021) and a structured clinical interview by the criteria of the revised text of the Diagnostic and Statistical Manual of Mental Disorders;
Being between 19 and 50 years old;
don't receive medication at the time of diagnosis and during the research period;
No history of substance abuse or substance dependence
Inefficiency of other psychological interventions</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having severe co-occurring disorders including major depressive disorder, personality disorders, bipolar disorders.
Having some kind of medical condition that makes the person seek immediate treatment
Patients with features of psychosis, mania or hypomania, or borderline personality disorders (because these patients have emotional instability and the process of evaluating their mood will be difficult).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder (PTSD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, acceptance and commitment therapy was performed. Acceptance and commitment therapy is one of the treatments of the third wave of behavioral therapy, which was introduced by Steven Hayes and his colleagues in the early 1980s and is known as ACT, and is rooted in a deep philosophy called functional contextualism, which is theoretically based on The theory is a framework of mental relations that explains how the human mind creates suffering and the useless methods of dealing with it, as well as alternative contextual approaches for these areas. This therapy focuses on the six aspects of acceptance, commitment in action, self as context, cognitive fusion, values, and presence in the present moment and seeks to improve psychological flexibility. The number of treatment sessions of this intervention can consist of 6 sessions and affect disorders such as major depressive disorder, anxiety disorders and trauma-related disorders.</i_keyword>
      <i_keyword>Control group: No treatment protocol was performed in this group. In this group of people suffering from prolonged grief disorder, they completed emotion regulation, self-compassion and cognitive fusion questionnaires in the pre-test and after 8 weeks, they repeated the previous questionnaires again. In these 8 weeks, no intervention has been done on this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Prolonged grief disorder. Timepoint: The study variables were measured before the intervention and after the intervention. Method of measurement: prolonged grief disorder score in the lprolonged griefquestionnaire of Prigerson et al. (2021).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Emotion regulation score. Timepoint: The variables of this study were measured before and after the intervention. Method of measurement: The emotion regulation score in John and Gross's 10 question emotion regulation questionnaire.</sec_outcome>
      <sec_outcome>Self-compassion. Timepoint: The variables of this study were measured before and after the intervention. Method of measurement: the self-compassion score in Self-Compassion Scale-Long Form by Neff et al (2003).</sec_outcome>
      <sec_outcome>Cognitive fusion. Timepoint: The variables of this study were measured before and after the intervention. Method of measurement: the cognitive fusion score in Gillanders' 12 question cognitive fusion questionnaire (2010).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-14</approval_date>
        <contact_name>Ethics committee of Sari Azad university</contact_name>
        <contact_address>Ghaemshahr- Shanzdeh Metri Street- Marmar Alley - Marvarid Building- 3rd floor sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
