<?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>IRCT2016121331391N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-05-17</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University of Medical Science</primary_sponsor>
      <public_title>The efficacy of acceptance and commitment therapy  on emotional, cognitive, physiological functions and quality of life in infertile women who undergoing in vitro fertilization</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of acceptance and commitment therapy  on emotional, cognitive, physiological functions and quality of life in infertile women who undergoing in vitro fertilization</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24704</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Anxiety. Condition 3: Memory. Condition 4: Quality of life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:&#13;
Intervention is designed as a group therapy. There are 8-10 members in each group. There are 8 sessions:&#13;
&#13;
Session1: "Problem is control" . "Present moment".&#13;
&#13;
In this session members are introduced to each others. Depression and anxiety are explained. The act perspective and present moment and brief mindfulness practice are discussed.&#13;
&#13;
Session 2: "Diffusion".&#13;
&#13;
 In this session, " Brief mindfulness" and "Leaves on a Stream" practices are done. Home works are reviewed and the challenges of them discussed. The concept of workability is explained.&#13;
&#13;
Session3: "Acceptance/Willingness".&#13;
&#13;
Acceptance which is also called willingness, coming back to present moment and brief mindfulness practice, group discussion about homework of workability are clarified.&#13;
&#13;
Session 4: "Values".&#13;
&#13;
Plans for this session are including: Review of mindfulness practice of the last session,  doing practice in the small groups and discussing in the large group, clarify the concept of "Values", doing practice and  a brief explanation of values in ACT. Stress the point that values are about action,  how you want to "be" and "act" in the world. And focus on commitment action to the values.&#13;
&#13;
 Session 5: "Self observation".&#13;
&#13;
The exercise" Mindfulness +Values", review of homeworks, group discussion, exercise" self-observation+Values", explaining of homework for next week are assigned for the 5th session. &#13;
&#13;
Session 6: "Commitment action".&#13;
&#13;
Description of the sixth session is: mindfulness practice, discussion about mindfulness, clarifying willingness with an exercise" Self-image", discussion again and doing practice.&#13;
&#13;
Session 7,8: All the last processes with concentration on making a larger frame according to commitment action with values are done. All majors are described in the last sessions and reviewed. Intervention 2: Control group:  They are just under prenatal cares and do not receive any education and practice.</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>Zhaleh Feyzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 34, Piroozi Bld 27.</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177916999</zip>
        <telephone>+98 51 3882 5433</telephone>
        <email>feyzij1@mums.ac.ir ; jfeyzi1973@yahoo.com</email>
        <affiliation>Kharazmi university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zhaleh feyzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No34, Piroozi Bld 27.</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177916999</zip>
        <telephone>+98 51 3882 5433</telephone>
        <email>feyzij1@mums.ac.ir ; j_feyzi1973@yahoo.com</email>
        <affiliation>Kharazmi university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: An infertile woman who undergoing IVF; Primary or secondary infertility; Age of pregnancy is 14-22 week; At least 2 years after marriage.&#13;
Exclusion criteria: History of any psychiatric diseases; Spacial medical diseases like diabetes, Cardiovascular diseases...</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
      <hc_code>F41</hc_code>
      <hc_code>F06</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Depressive episode</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
      <hc_keyword>Other mental disorders due to brain damage and dysfunction and to physical disease</hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:&#13;
Intervention is designed as a group therapy. There are 8-10 members in each group. There are 8 sessions:&#13;
&#13;
Session1: "Problem is control" . "Present moment".&#13;
&#13;
In this session members are introduced to each others. Depression and anxiety are explained. The act perspective and present moment and brief mindfulness practice are discussed.&#13;
&#13;
Session 2: "Diffusion".&#13;
&#13;
 In this session, " Brief mindfulness" and "Leaves on a Stream" practices are done. Home works are reviewed and the challenges of them discussed. The concept of workability is explained.&#13;
&#13;
Session3: "Acceptance/Willingness".&#13;
&#13;
Acceptance which is also called willingness, coming back to present moment and brief mindfulness practice, group discussion about homework of workability are clarified.&#13;
&#13;
Session 4: "Values".&#13;
&#13;
Plans for this session are including: Review of mindfulness practice of the last session,  doing practice in the small groups and discussing in the large group, clarify the concept of "Values", doing practice and  a brief explanation of values in ACT. Stress the point that values are about action,  how you want to "be" and "act" in the world. And focus on commitment action to the values.&#13;
&#13;
 Session 5: "Self observation".&#13;
&#13;
The exercise" Mindfulness +Values", review of homeworks, group discussion, exercise" self-observation+Values", explaining of homework for next week are assigned for the 5th session. &#13;
&#13;
Session 6: "Commitment action".&#13;
&#13;
Description of the sixth session is: mindfulness practice, discussion about mindfulness, clarifying willingness with an exercise" Self-image", discussion again and doing practice.&#13;
&#13;
Session 7,8: All the last processes with concentration on making a larger frame according to commitment action with values are done. All majors are described in the last sessions and reviewed.</i_keyword>
      <i_keyword>Control group:  They are just under prenatal cares and do not receive any education and practice.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before, After, One-month follow-up. Method of measurement: Beck depression scale, SCID.</prim_outcome>
      <prim_outcome>Cortisol(Phisiologic changes). Timepoint: Before, After, One-month follow-up. Method of measurement: Blood cortisole.</prim_outcome>
      <prim_outcome>Every day memory. Timepoint: Before, After, One-month follow-up. Method of measurement: Rivermead Behavioural Memory Test- Third Edition.</prim_outcome>
      <prim_outcome>Working memory. Timepoint: Before, After, One-month follow-up. Method of measurement: Riding test.</prim_outcome>
      <prim_outcome>Authobiographical memory. Timepoint: Before, After, One-month follow-up. Method of measurement: AMT(Autobiographical Memory Test).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before, After, One-month follow-up. Method of measurement: World Health Organization Quality Of Life Questionaire(WHOQOL Brief).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before, After, One-month follow-up. Method of measurement: Beck anxiety scale, SCID.</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>Vice chancellor for research, Mashhad University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-26</approval_date>
        <contact_name>Ethics committee of mashad university of medical sciences</contact_name>
        <contact_address>Ghorshy bulding. Daneshgah street Mashad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
