<?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>IRCT20190401043150N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-30</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of  Acceptance and Commitment Therapy (ACT) on Quality of Life in menopause Women</public_title>
      <acronym>ACT</acronym>
      <scientific_title>Survey of the Effectiveness of  Acceptance and Commitment Therapy (ACT) on Quality of Life in menopause Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38679</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomized sequences under the web and by person who out of the research team will be done. Randomized foursome block as a limited method will be used and the people in the order of arrival will stay on blocks. The researcher put each allocation in closed white packet and numbered it.Qualified people in the order of arrival will be register by researcher and receive a code and relevant  questionnaire complete for theme.Then according to the codes one packet will be opened and the person will be allocated to one of the groups, Blinding description: The Participants of each group do not aware about existence of another group. Researcher dose not aware about randomized allocation because of closed packets. After intervention questionnaires will complete by another person except researcher. The analyzer dose not aware about the people in the groups nether.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Quality of life in menopause.</hc_freetext>
      <i_freetext>Intervention 1: Control group: dose not recieve any intervention. Intervention 2: Intervention group: this group will recieve the consultation Acceptance and Commitment Therapy (ACT). The women in the intervention group, in addition to routine menopausal care receive counseling weekly for 6 sessions of 90 minutes, with Acceptance and Commitment (ACT) Therapy and structured commitment in each session, with mind-awareness training, review of previous sessions, potential support exercises, and homework assignments In this model, counseling and treatment will be provided. The content of the sessions is based on Acceptance and Commitment (ACT) Therapy to anxiety and depression, which is based on the six process (Acceptance, Defusion , Self as a context, Contact with present moment, recognition of values and committed action). The samples are gradually being enrolled in the study, samples are collected for 10 people who have received weekly sessions, and simultaneous sampling is ongoing for both groups. The length of the consultation period is expected to be two months for each 10-member group.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
puplishable data include thesis interpreted results and papers and protocol if needed

When:
Access from 2019-2020

To whom:
Data are access for all researchers in scientific institudes

Conditions:
In case of Author's permission

Where to obtain:
To corresponding author or executive author

How to obtain:
By contact with the departmant or send an email to authors

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.1,Second Alley., Payam Ave</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9618913111</zip>
        <telephone>+98 51 4465 9787</telephone>
        <email>s.ghasemi3060@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.1,Second Alley., Payam Ave</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9618913111</zip>
        <telephone>+98 51 4465 9787</telephone>
        <email>s.ghasemi3060@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iranian nationality
Literacy reading and writing
Age range 45-60 years
Physiologic menopause
At least 12 months have passed since the last menstruation
Hormone replacement therapy has not been consumed within the last 6 months
Not having certain diseases like cancer
Do not have drug addiction
No restrictions on attending meetings
The desire to participate in the study and fill out the informed consent form
Non-use of psychiatric drugs
The lack of a crisis in the last year, like the death of one of the loved ones, and so on</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Do not attend more than two sessions
Unwillingness to continue to study
Crisis in the family from the beginning of the study to the end of a one-month follow-up</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: dose not recieve any intervention</i_keyword>
      <i_keyword>Intervention group: this group will recieve the consultation Acceptance and Commitment Therapy (ACT). The women in the intervention group, in addition to routine menopausal care receive counseling weekly for 6 sessions of 90 minutes, with Acceptance and Commitment (ACT) Therapy and structured commitment in each session, with mind-awareness training, review of previous sessions, potential support exercises, and homework assignments In this model, counseling and treatment will be provided. The content of the sessions is based on Acceptance and Commitment (ACT) Therapy to anxiety and depression, which is based on the six process (Acceptance, Defusion , Self as a context, Contact with present moment, recognition of values and committed action). The samples are gradually being enrolled in the study, samples are collected for 10 people who have received weekly sessions, and simultaneous sampling is ongoing for both groups. The length of the consultation period is expected to be two months for each 10-member group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life in menopausal women is measured using the WHO Quality of Life Questionnaire and Quality of Life questionnaire for menopausal women. Timepoint: Before the intervention, immediately after the intervention, during the follow-up one month later. Method of measurement: World Health Organization Quality of Life Questionnaire and Quality of Life Questionnaire for menopausal Women.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-08</approval_date>
        <contact_name>Ethics committee of Shahrood University of Medical Sciences</contact_name>
        <contact_address>7th tir square, shahrood University of Medical Sciences Shahrood Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
