<?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>IRCT2016112631030N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-02-15</date_registration>
      <primary_sponsor>Jondi  Shapour University Of  Medical Sciences</primary_sponsor>
      <public_title>The Effect  Of Group  Cognitive-Behavioral  Therapy (CBT)On  Health  Promotion  Life Style  Of  Post Menopausal   Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effect  Of Group  Cognitive-Behavioral  Therapy (CBT)On  Health  Promotion  Life Style  Of  Post Menopausal   Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>33</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24484</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Life Style.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:    Eight sessions of cognitive - behavioral therapy in groups will be held in weekly meetings . The duration of each session will be 90 minutes. In these meetings, the influence of the thoughts  on emotional and behavioral and The impact of negative thoughts on Lifestyle-related behaviors will be explained. Promoting healthy lifestyle before and after the consultation and 6 weeks after the intervention  will  be evaluated. Intervention 2: Control group: Did not receive any treatment and only received usual care health. For observe ethical principles, Two sessions on menopause, its symptoms, lifestyle and its effects on menopausal symptoms as well as cognitive-behavioral therapy model for Control group will be held.  Health promoting lifestyle of this group will be evaluated In these times( before and after the consultation and 6 weeks after).</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shiva Yazdizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School  Of  Nursing  And  Midwifery,  Jondi  Shapour University Of  Medical  Sciences, University Town, Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 933 196 2105</telephone>
        <email>shiva_yazdizadeh@yahoo.com</email>
        <affiliation>School Of  Nursing  And  Midwifery  Ahvaz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Poorandokht  Afshri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School Of  Nursing And  Midwifery, Jondi  Shapour  University  Of   Medical  Sciences,  University  Town,  Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>00</telephone>
        <email>p_afshary@yahoo.com</email>
        <affiliation>School  Of  Nursing  And  Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : Natural menopause (Absence of Menstruation for at Least One Year );Women Who Will Aguire Score of Lifestyle Scale in Medium (104-155) or Weak (befor 103) Level; Having Educational Level of Primery School;The Appropriateness of Participitent for CBT;Age 45 - 60 Years And Exclusion criteria :Mental and Physical Diseases Based on Self Report;Having Sad Events During The Last Six Months;History of Previous Use of Cognitive- Behavioral Therapy; Addictions to Alcohol, Drugs and Other Psycholic Drugs Based on Self Report؛Use of Antipsychotic Drugs</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z72</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems related to lifestyle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:    Eight sessions of cognitive - behavioral therapy in groups will be held in weekly meetings . The duration of each session will be 90 minutes. In these meetings, the influence of the thoughts  on emotional and behavioral and The impact of negative thoughts on Lifestyle-related behaviors will be explained. Promoting healthy lifestyle before and after the consultation and 6 weeks after the intervention  will  be evaluated.</i_keyword>
      <i_keyword>Control group: Did not receive any treatment and only received usual care health. For observe ethical principles, Two sessions on menopause, its symptoms, lifestyle and its effects on menopausal symptoms as well as cognitive-behavioral therapy model for Control group will be held.  Health promoting lifestyle of this group will be evaluated In these times( before and after the consultation and 6 weeks after)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spiritual  Growth. Timepoint: Befor  And  Immidiately  After  Intervention  And  Six  Weeks  Later. Method of measurement: HPLQ(Health   Promotion  Life Style   Questionnare ).</prim_outcome>
      <prim_outcome>Responsibility  For Health. Timepoint: Befor  And  Immidiately  After  Intervention  And  Six  Weeks  Later. Method of measurement: HPLQ(Health  Promotion  Life Style  Questionnare ).</prim_outcome>
      <prim_outcome>Interpersonal  Relationships. Timepoint: Befor  And  Immidiately  After  Intervention  And  Six  Weeks  Later. Method of measurement: HPLQ(Health  Promotion  Life Style  Questionnare ).</prim_outcome>
      <prim_outcome>Stress  Management. Timepoint: Befor  And  Immidiately  After  Intervention  And  Six  Weeks  Later. Method of measurement: HPLQ(Health  Promotion  Life Style  Questionnare ).</prim_outcome>
      <prim_outcome>Sport. Timepoint: Befor  And  Immidiately  After  Intervention  And  Six  Weeks  Later Later. Method of measurement: HPLQ(Health  Promotion  Life Style  Questionnare ).</prim_outcome>
      <prim_outcome>Nutrition. Timepoint: Befor  And  Immidiately  After  Intervention  And  Six  Weeks  Later. Method of measurement: HPLQ(Health  Promotion  Life Style  Questionnare ).</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>Jondi  Shapour University Of  Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-02</approval_date>
        <contact_name>Jondi  Shapour University Of  Medical Sciences</contact_name>
        <contact_address>Jondi Shapour  University  Of   Medical   Sciences,  University   Town,  Golestan Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
