<?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>IRCT20230105057059N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-06</date_registration>
      <primary_sponsor>The University of semnan</primary_sponsor>
      <public_title>The effectiveness of human givens therapy on psychological distress and quality of life</public_title>
      <acronym>HGT</acronym>
      <scientific_title>The effectiveness of human givens therapy on psychological distress and quality of life of the elderly living in a nursing home</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67924</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Simple randomization,individual,manual selection.The list of seniors who meet the entry criteria will be numbered and the test group will be completed by lottery, and then the lottery will be done again to complete the proof group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Psychological distress. Condition 2: Quality of life.</hc_freetext>
      <i_freetext>Intervention 1: Seven treatment sessions for human givens, once a week and the duration of each session is 45 minutes.Therapy sessions are done in groups. The content of the sessions includes establishing therapeutic communication, assessing the condition and severity of the disorder, examining and evaluating emotional needs and their role in the occurrence of disturbance. Providing the task of identifying needs such as the need for security. Investigating the unsatisfied needs of every elderly person, how emotions arise due to exposure to stimuli with mental patterns, presenting the task of identifying the motivating stimuli, paying attention to inherent resources such as (empathy, past memories, dreaming of the thinking mind, etc.), investigating the irrational thoughts of the elderly, analyzing General information with the approach of hope and optimism and analysis of the way of satisfying individual needs and resources in the nursing home and creating a new story for living and thinking in different and successful ways. Intervention 2: Control group:They do not receive intervention.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Kalantarabharpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 13,Aflak11 Bldg,mokremy alley,emam Quarter ,damghan Town</address>
        <city>Damghan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3671693144</zip>
        <telephone>+98 23 3526 3555</telephone>
        <email>m.kalantar.a@semnan.ac.ir</email>
        <affiliation>The University of semnan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Kalantarabharpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 13,Aflak11 Bldg,mokremy alley,emam Quarter ,damghan Town</address>
        <city>Damghan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3671693144</zip>
        <telephone>+98 23 3526 3555</telephone>
        <email>m.kalantar.a@semnan.ac.ir</email>
        <affiliation>The University of semnan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Literacy for reading and writing
Age range from 60 to 75 years</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>receiving medical and psychological treatments during the last six months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></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>Seven treatment sessions for human givens, once a week and the duration of each session is 45 minutes.Therapy sessions are done in groups. The content of the sessions includes establishing therapeutic communication, assessing the condition and severity of the disorder, examining and evaluating emotional needs and their role in the occurrence of disturbance. Providing the task of identifying needs such as the need for security. Investigating the unsatisfied needs of every elderly person, how emotions arise due to exposure to stimuli with mental patterns, presenting the task of identifying the motivating stimuli, paying attention to inherent resources such as (empathy, past memories, dreaming of the thinking mind, etc.), investigating the irrational thoughts of the elderly, analyzing General information with the approach of hope and optimism and analysis of the way of satisfying individual needs and resources in the nursing home and creating a new story for living and thinking in different and successful ways.</i_keyword>
      <i_keyword>Control group:They do not receive intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological distress. Timepoint: Before the start and after the end of therapy. Method of measurement: kessler psychological distress questionnaire scale k10.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the start and after the end of therapy. Method of measurement: the LEIPAD standard quality of life questionnaire for the elderly.</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>The University of semnan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-26</approval_date>
        <contact_name>Ethics committee of semnan University ofMedical Sciences</contact_name>
        <contact_address>Floor 13,Block A,Ministry of Health &amp;Medical Education Headquarters,Between Zarafshan&amp;South Falamak,Qods Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
