<?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>IRCT20210619051617N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Logotherapy on Reducing Stress and Increasing Resilience and Quality of Life in Obese People</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Logotherapy on Reducing Stress and Increasing Resilience and Quality of Life in Obese People</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56970</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The way of sampling in this research, considering the choosing of the entrance of the samples is non-random, and considering the way of placement in the intervention and control group is simple random and done through draw and individual randomization unit.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obesity.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: First, a questionnaire is given to both control group and experimental group. After separating the groups, the logotherapy training intervention was used for the experimental group. Logotherapy is a branch of the existential approach that deals with "finding the meaning and purpose of people's lives to accept their suffering.". Workshop for the experimental group consisted of 10 sessions for 5 weeks in which participants received training twice a week for 90 minutes by presenting videos, booklets, flashcards and Introducing books. The sessions are as follows: The first session includes the existential ontology and 4 concepts of death, loneliness, freedom and meaninglessness and awareness of values; The second session includes practicing identified and substituted occupations, discovering satisfying achievements, and exploring creative values; The third session includes analysis and evaluation of recent events, positive people and artistic experiences; The fourth session includes analyzing and evaluating wise quotes, taking a point of view, and doing the practice of "My obituary" in groups; The fifth session includes expanding the hierarchy of values, setting goals, changing the perspective towards goals; the sixth session includes investigating the relevance of goals to values ​​and explaining the necessity to experience all of one's values; Seventh session includes setting new goals for the ignored values; The eighth session includes the plan to achieve short-term and long-term goals; The ninth session includes investigating the strengths and weaknesses for moving towards the goals, changing the status of the strengths and weaknesses; tenth session includes summarizing the content of all of the sessions, group discussion and motivation Then, in order to evaluate the effectiveness of the intervention, a questionnaire was given to both groups again to compare the changes obtained from training in the training group with the control group. It should be noted that no drug treatment was used in this. Intervention 2: Control group: There was no intervention on the control group and this group completed the study questionnaires in only two stages.</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 Ensure the protection of personal information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sana Kamboozia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 67, Daadgostar Alley, Darvazeh Lakan Street, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4196614668</zip>
        <telephone>+98 13 3342 4483</telephone>
        <email>Sana.kamboozia@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sana Kamboozia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 67, Dadgostar 1 Alley, Darvazeh Lakan Blvd, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4196614668</zip>
        <telephone>+98 13 3342 4483</telephone>
        <email>Sana.kamboozia@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a BMI higher than 25
Satisfaction of people to participate in treatment sessions
Not having any chronic medical condition based on the individual's own report</inclusion_criteria>
      <agemin>24 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of psychiatric problems
The distortion of the questionnaire
Lack of entrance criteria</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: First, a questionnaire is given to both control group and experimental group. After separating the groups, the logotherapy training intervention was used for the experimental group. Logotherapy is a branch of the existential approach that deals with "finding the meaning and purpose of people's lives to accept their suffering.". Workshop for the experimental group consisted of 10 sessions for 5 weeks in which participants received training twice a week for 90 minutes by presenting videos, booklets, flashcards and Introducing books. The sessions are as follows: The first session includes the existential ontology and 4 concepts of death, loneliness, freedom and meaninglessness and awareness of values; The second session includes practicing identified and substituted occupations, discovering satisfying achievements, and exploring creative values; The third session includes analysis and evaluation of recent events, positive people and artistic experiences; The fourth session includes analyzing and evaluating wise quotes, taking a point of view, and doing the practice of "My obituary" in groups; The fifth session includes expanding the hierarchy of values, setting goals, changing the perspective towards goals; the sixth session includes investigating the relevance of goals to values ​​and explaining the necessity to experience all of one's values; Seventh session includes setting new goals for the ignored values; The eighth session includes the plan to achieve short-term and long-term goals; The ninth session includes investigating the strengths and weaknesses for moving towards the goals, changing the status of the strengths and weaknesses; tenth session includes summarizing the content of all of the sessions, group discussion and motivation Then, in order to evaluate the effectiveness of the intervention, a questionnaire was given to both groups again to compare the changes obtained from training in the training group with the control group. It should be noted that no drug treatment was used in this.</i_keyword>
      <i_keyword>Control group: There was no intervention on the control group and this group completed the study questionnaires in only two stages.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The stress score in Social Readjustment Rating Scale (SRRS). Timepoint: Assessment will be done once at the beginning of the study and once after the intervention. Method of measurement: Social Readjustment Rating Scale (SRRS).</prim_outcome>
      <prim_outcome>Resilience Score in the Connor-Davidson Resilience Scale (CD_RIS). Timepoint: Assessment will be done once at the beginning of the study and once after the intervention. Method of measurement: Connor-Davidson Resilience Scale (CD_RIS).</prim_outcome>
      <prim_outcome>WHOQOL- BREF Score. Timepoint: Assessment will be done once at the beginning of the study and once after the intervention. Method of measurement: WHOQOL- BREF.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-28</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University - Lahijan Branch</contact_name>
        <contact_address>No. 67, Daadgostar Alley, Darvazeh Lakan Street, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
