<?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>IRCT20100211003329N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-27</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Happiness on the Psychological capital</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Happiness on the Psychological capital of Middle aged women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42541</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will  be assigned two groups Using the block randomization technique by the software sealed Envelope Ltd.2017 Available from through www.sealedenvelope.com,12 blocks ( 6 blocks with 6 people and 6 block with 4 people) were defined. The blocks are divided into 2 categories based on the list taken from the site and randomly each category of blocks will be selected from one center. After identifying the members of the groups by random allocation, for people in intervention group, group intervention will be conducted in two separate groups in each center, Blinding description: Data analyzer is unaware of experimental and control group characteristics.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychological capital.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will receive a group happiness program based on the Fordisee protocol during 8 sessions of 90 minutes (2 sessions per week at least two days apart). The first session begins with welcoming the members, introducing the group leader to the members and members to each others, discussing the goals, reviewing the structure of the meetings, the rules governing the group, and the duties and responsibilities of the members and the group leader.The goals of the sessions in the intervention group from the first to the eighth meeting respectively including; the need for happiness in life, Importance of leisure and entertainment, Increasing intimacy and social relationships, Stop worrying and living in the present time, lowering the level of optimism and positive thinking and optimism, planning and organization affairs, healthy personality and self-importance and the importance of happiness that can be achieved through group discussion, practicing group, home and community exercises. At the beginning of each session the members report and discuss the exercises and tasks, then work on the purpose of the meeting. At the end of each session, members of the group will be welcomed and the time and title of the next meeting will be indicated. Intervention 2: Control group: The control group will have no intervention about happiness and will only receive routine care at the health center including assessment of chronic diseases and cancers, etc.</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 need to publish data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahime sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotb Ravandi Blvd, Pezeshk Blvd, Kashan University of Medical Sciences</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715985191</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>sadeghi-f@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadijeh Sharifi- Zahra Tagharrobi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ghotb Ravandi Blvd, Pezeshk Blvd, Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715985191</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>sharifi_kh@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having informed consent to participate in research
Age 40-65 years
Living in Kashan
Iranian nationality
The ability of talking and listening
Ability to communicate in Persian
Earning a score of less than 112 (on a scale of 156-26)  From the psychological capital tools of McGee et al.
Having the physical ability to attend meetings</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Known mental illness (self-reporting)
Known mental retardation
Deal with acute and serious stress in the last 6 months (death of relatives, serious illness or relatives, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will receive a group happiness program based on the Fordisee protocol during 8 sessions of 90 minutes (2 sessions per week at least two days apart). The first session begins with welcoming the members, introducing the group leader to the members and members to each others, discussing the goals, reviewing the structure of the meetings, the rules governing the group, and the duties and responsibilities of the members and the group leader.The goals of the sessions in the intervention group from the first to the eighth meeting respectively including; the need for happiness in life, Importance of leisure and entertainment, Increasing intimacy and social relationships, Stop worrying and living in the present time, lowering the level of optimism and positive thinking and optimism, planning and organization affairs, healthy personality and self-importance and the importance of happiness that can be achieved through group discussion, practicing group, home and community exercises. At the beginning of each session the members report and discuss the exercises and tasks, then work on the purpose of the meeting. At the end of each session, members of the group will be welcomed and the time and title of the next meeting will be indicated.</i_keyword>
      <i_keyword>Control group: The control group will have no intervention about happiness and will only receive routine care at the health center including assessment of chronic diseases and cancers, etc.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological capital. Timepoint: Start, Immediately after the intervention and one month later. Method of measurement: (  Psychological capital Questionnaire (McGee et al).</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-21</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Ghotb Ravandi Blvd, Pezeshk Blvd, Kashan University of Medical Sciences kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
