<?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>IRCT20200428047230N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-05</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The comparison of the effectiveness of approach CBT and ACT on sexual function and sexual schemas in postmenopausal women</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effectiveness of approach CBT and ACT on sexual function and sexual schemas in postmenopausal women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47575</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The researcher randomly selected 3 centers out of 18 health centers in Zanjan by writing numbers on paper by drawing lots, then by referring to the mentioned health center, 45 of them were selected by available sampling method and coded from 1-45. Using randomly assigned block allocation methods, they were divided into 3 groups of 15 people (2 intervention groups and one control group). How to do it: First we encode the groups based on the Latin letters as follows: A = cognitive-behavioral therapy, B = acceptance and commitment treatment and C = control group In this study with three groups A, B and C, the following six groups were created: And we assign the numbers 1 to 6 to each: ABC-ACB-BAC-BCA-CAB-CBA Then we contract using a table of random numbers, whenever the numbers 1, 2, 3, 4, 5, and 6, respectively. It appeared that one of these blocks would be selected, and if another number appeared, we assumed it to be null and void and moved on to the next selection. In fact, we get a random sequence of numbers with a table of random numbers, which we consider the order of the assigned allocation for each number. In this way, the number of people in the groups is almost equal.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sexual Function.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention Group 1 CBT - (Cognitive-Behavioral Therapy), Treatment sessions are performed in 8 sessions (each session approximately 2 hours per week for 2 months) according to the protocol (Kaplan, 1974; Kennedy, 2012). Measurements are taken with pre-test, post-test and follow-up 3 months later. Intervention 2: Intervention group: Intervention Group 2: ACT - ( Acceptance and Commitment-Based Therapy), Treatment sessions are performed in 8 sessions (each session approximately 2 hours per week for 2 months) according to the protocol (Kaplan 1974; Foreman and Herbert 2008). Measurements are taken with pre-test, post-test and follow-up 3 months later. Intervention 3: Control group: Control group: A 15-member control group, on which no intervention is performed and is only for comparison with the intervention groups. Measurements are taken with pre-test, post-test and follow-up 3 months later.</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 Undecided - It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Rostamkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Transit Road Km 4 Abhar- Khorram Dareh</address>
        <city>Abhar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4561934367</zip>
        <telephone>+98 24 3522 6080</telephone>
        <email>frostamkhani47@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Rostamkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Student Square, Zanjan Branch, Islamic Azad University</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45156-58145</zip>
        <telephone>+98 24 3346 5007</telephone>
        <email>frostamkhani47@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>-Married women
-Menopausal women that have menopause in 5 past year
-Sexual performance score below 28 with FSFI questionnaire
-Completed Secondary education level
-Have willingness to participate in the study
-Being monogamy</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>-Having known physical and mental illness according to self-reported
-Consumption of drugs affecting sexual relationships
-Addiction
-Participate in other similar studies
-Occurrence of unpleasant event</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>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention Group 1 CBT - (Cognitive-Behavioral Therapy), Treatment sessions are performed in 8 sessions (each session approximately 2 hours per week for 2 months) according to the protocol (Kaplan, 1974; Kennedy, 2012). Measurements are taken with pre-test, post-test and follow-up 3 months later.</i_keyword>
      <i_keyword>Intervention group: Intervention Group 2: ACT - ( Acceptance and Commitment-Based Therapy), Treatment sessions are performed in 8 sessions (each session approximately 2 hours per week for 2 months) according to the protocol (Kaplan 1974; Foreman and Herbert 2008). Measurements are taken with pre-test, post-test and follow-up 3 months later.</i_keyword>
      <i_keyword>Control group: Control group: A 15-member control group, on which no intervention is performed and is only for comparison with the intervention groups. Measurements are taken with pre-test, post-test and follow-up 3 months later.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Menopausal women  who receive sexual performance scores less than 28 with FSFI Questionnaire. Timepoint: Pre-test, post _test and follow up. Method of measurement: FSFI Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual schemas. Timepoint: Pre-test, Post-test and follow up. Method of measurement: Women’s sexual self-schema Questionnaire.</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>2019-10-15</approval_date>
        <contact_name>Ethics committee of zanjan University of Medical Sciences</contact_name>
        <contact_address>Azadi Square, Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
