<?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>IRCT20211223053494N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-27</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of acceptance and commitment therapy on death anxiety and psychological health in the range of 55-70: A preventive research</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of acceptance and commitment therapy on death anxiety and psychological health in the range of 55-70 in Zanjan: A preventive research</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be simple randomization. The randomization unit is individual. Through the table of random numbers, which are produced without any particular pattern and order and are completely random and are made into a table, the names of the participants will be collected as a set of numbers and the numbers will be used to categorize different groups.
Even numbers are in the intervention group and odd numbers are in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>death anxiety and psychological health.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: includes all the elderly of Zanjan city who receive acceptance and commitment therapy as a group according to the protocol in ten 90-minute weekly sessions. This therapy was designed by Steven Hayes and colleagues and was written in Iran in the form of a book entitled "Acceptance and Commitment Therapy " by Izadi and Abedi. The content of the first session: getting to know the group members and their expectations, determining the group policy, establishing a relationship with the members, distributing research questionnaires, briefly explaining the treatment method, using mindfulness exercises and presenting assignments (checking control strategies). Content of the second session: review of the assignment of the previous session, exercise of creative frustration, exercise of body scan meditation, and presentation of homework (body scan at home). Content of the third session: review of the previous session, breathing exercise, introduction of the life course model, self-disclosure exercise, paying attention to the present moment without judgment, presenting homework. The content of the fourth session: reviewing the assignments of the previous session, practicing acceptance of problems, teaching the use of desire instead of control by presenting the metaphor of the bus and the metaphor of the beggar, practicing mindfulness with breathing and presenting the assignment. Content of the fifth session: review of the previous session along with homework, training to observe the passing of thoughts, training to solve thinking reminder cards, group practice of breaking thoughts and presenting homework. Content of the sixth session: review of the previous session with assignments, life map training, using the chess metaphor in order to understand oneself as a context, presentation of the assignment. Content of the 7th session: Homework review, teaching to use values as a substitute for control, teaching joint commitment, presenting homework. The content of the eighth session: review of the previous session, teaching the concept of values and goals and the difference between them, presenting the values and goals form to the participants, at the end of presenting the task (ranking of values). Content of the 9th session: reviewing the past session and assignments, teaching the effects of paying attention to the past and future instead of choosing the present, teaching concentration exercises, reviewing the value rating assignments, summarizing the meeting and presenting homework (practical actions to achieve values). Content of the 10th session: review homework, review drawing a path to pursue values and the future, identify dangerous situations in the future, sum up the sessions, and do the post-test. 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>Seyedeh Elnaz Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1452687818</zip>
        <telephone>+98 24 3353 4500</telephone>
        <email>Dr.Emousavi@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyedeh Elnaz Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ark Square, Shahid Beheshti Hospital, Department of Clinical Psychology, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1452368712</zip>
        <telephone>+98 24 3353 4500</telephone>
        <email>Dr.Emousavi@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in research
Age between 55 and 70 years
Absence of acute and chronic mental illnesses
Not receiving psychiatric drugs
Not receiving psychological treatments in the last year
Absence of substance abuse disorders
Not suffering from chronic physical diseases, including types of cancer and other acute physical problems</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of more than two sessions
Reluctance to continue treatment sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Psychological and behavioral factors associated with disorders or diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: includes all the elderly of Zanjan city who receive acceptance and commitment therapy as a group according to the protocol in ten 90-minute weekly sessions. This therapy was designed by Steven Hayes and colleagues and was written in Iran in the form of a book entitled "Acceptance and Commitment Therapy " by Izadi and Abedi. The content of the first session: getting to know the group members and their expectations, determining the group policy, establishing a relationship with the members, distributing research questionnaires, briefly explaining the treatment method, using mindfulness exercises and presenting assignments (checking control strategies). Content of the second session: review of the assignment of the previous session, exercise of creative frustration, exercise of body scan meditation, and presentation of homework (body scan at home). Content of the third session: review of the previous session, breathing exercise, introduction of the life course model, self-disclosure exercise, paying attention to the present moment without judgment, presenting homework. The content of the fourth session: reviewing the assignments of the previous session, practicing acceptance of problems, teaching the use of desire instead of control by presenting the metaphor of the bus and the metaphor of the beggar, practicing mindfulness with breathing and presenting the assignment. Content of the fifth session: review of the previous session along with homework, training to observe the passing of thoughts, training to solve thinking reminder cards, group practice of breaking thoughts and presenting homework. Content of the sixth session: review of the previous session with assignments, life map training, using the chess metaphor in order to understand oneself as a context, presentation of the assignment. Content of the 7th session: Homework review, teaching to use values as a substitute for control, teaching joint commitment, presenting homework. The content of the eighth session: review of the previous session, teaching the concept of values and goals and the difference between them, presenting the values and goals form to the participants, at the end of presenting the task (ranking of values). Content of the 9th session: reviewing the past session and assignments, teaching the effects of paying attention to the past and future instead of choosing the present, teaching concentration exercises, reviewing the value rating assignments, summarizing the meeting and presenting homework (practical actions to achieve values). Content of the 10th session: review homework, review drawing a path to pursue values and the future, identify dangerous situations in the future, sum up the sessions, and do the post-test.</i_keyword>
      <i_keyword>Control group:  No Treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Death anxiety score in Templer's death anxiety questionnaire. Timepoint: At the beginning of the study (before the intervention), after the intervention and 1month after the intervention. Method of measurement: Templer Death Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>The score of morbid symptoms in the morbid symptom checklist questionnaire (SCL-90-R) by Derogatis and Cleary. Timepoint: At the beginning of the study (before the intervention), after the intervention and 1month after the intervention. Method of measurement: The Symptom Checklist-90-R (SCL-90-R).</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-17</approval_date>
        <contact_name>Research Ethics Committees of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Department of Clinical Psychology, Shahid Beheshti Hospital, Ark Square, Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
