<?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>IRCT20230123057194N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-13</date_registration>
      <primary_sponsor>Personal</primary_sponsor>
      <public_title>The comparison of the effectiveness of metacognitive therapy, acceptance and commitment therapy and Pilates exercises  in the women with premenstrual syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The comparison of the effectiveness of metacognitive therapy, acceptance and commitment therapy and Pilates exercises on emotional self-regulation, loneliness feeling, dysfunctional attitudes, and distress tolerance in the women with premenstrual syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68220</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Available sampling method, simple randomization: each person was presented with 4 sealed envelopes in the number of groups (three experimental groups and one control), based on the choice of an envelope by the subject himself, his placement in a group is done. Individual unit.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Premenstrual Syndrome.</hc_freetext>
      <i_freetext>Intervention 1: The structure of the acceptance and commitment treatment protocol sessions, which is taken from the article by Hayes et al. (2016), is implemented in a group for eight weeks and a two-hour session every week for women with PMS. Intervention 2: The structure of the sessions of metacognitive therapy protocol, which is taken from the article of Wells (2009), is implemented for ten weeks and a two-hour session every week for women with premenstrual syndrome. Intervention 3: The structure of the Pilates exercise protocol session, which is taken from the research of Taghizadeh et al. (2020) and Ghorbanian and Mahmoodpoor (2019), is performed for eight weeks and three one-hour sessions every week for women with premenstrual syndrome as a group. Intervention 4: Control group: without 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azadeh Niroomand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nawab Square - Yadgar Imam St.</address>
        <city>Borujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6915136111</zip>
        <telephone>+98 66 4251 8000</telephone>
        <email>az.niroomand@gmail.com</email>
        <affiliation>Islamic Azad University. Borujerd Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Niroomand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Navab Sq. Yadegare Emam Street</address>
        <city>Borujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6915973863</zip>
        <telephone>+98 66 4251 8000</telephone>
        <email>az.niroomand@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of the syndrome of the subjects based on the screening questionnaire (cut point 28 and above)
Informed consent to participate in research
Lack of medication for menstrual problems before the study
No abuse of tobacco, drugs and cigarettes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Taking psychiatric and psychoactive drugs
Absence of more than 2 sessions in treatment sessions
Simultaneous participation in other courses and therapeutic interventions at the same time as research
Drug abuse and smoking
Having psychiatric disorders based on the person's self-report</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Premenstrual tension syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The structure of the acceptance and commitment treatment protocol sessions, which is taken from the article by Hayes et al. (2016), is implemented in a group for eight weeks and a two-hour session every week for women with PMS.</i_keyword>
      <i_keyword>The structure of the sessions of metacognitive therapy protocol, which is taken from the article of Wells (2009), is implemented for ten weeks and a two-hour session every week for women with premenstrual syndrome.</i_keyword>
      <i_keyword>The structure of the Pilates exercise protocol session, which is taken from the research of Taghizadeh et al. (2020) and Ghorbanian and Mahmoodpoor (2019), is performed for eight weeks and three one-hour sessions every week for women with premenstrual syndrome as a group.</i_keyword>
      <i_keyword>Control group: without intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Premenstrual syndrome cut point score is 28. Timepoint: pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session). Method of measurement: Premenstrual Screening Questionnaire (PSST) Steiner et al. (2003).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The intervention should increase self-emotional regulation. Timepoint: pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session). Method of measurement: Emotional self-regulation questionnaire (ERQ) Gross and John (2003).</sec_outcome>
      <sec_outcome>The intervention should decrease the loneliness feeling. Timepoint: pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session). Method of measurement: Loneliness Scale-Third Edition (UCLA LS3) Russell (1996).</sec_outcome>
      <sec_outcome>The intervention should decrease the dysfunctional attitudes. Timepoint: pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session). Method of measurement: Dysfunctional Attitudes Questionnaire (DAS) by Beck and Wiseman (1978).</sec_outcome>
      <sec_outcome>The intervention should increase the distress tolerance. Timepoint: pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session). Method of measurement: Distress Tolerance Scale (DTS) Simmons and Gaher (2005).</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>Personal</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-20</approval_date>
        <contact_name>Ethics committee in Research of Islamic Azad University, Borujerd Branch</contact_name>
        <contact_address>No 26, Moazami  Alley, Golstan Blvd. Takhti St. Borujerd Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
