<?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>IRCT20191014045096N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-28</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Effect of treatment  based Emotional efficacy on the Faulty Cognitive-affective system, Psychological syndrome and Sleep Quality of Nurses with Anxiety Signs</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Transdiagnostic based Emotional efficacy on the Faulty Cognitive-affective system, Psychological syndrome and Sleep Quality of Nurses with Anxiety Signs</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43027</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization, among the nurses working in Ferdowsi hospitals, 140 people who meet the inclusion criteria will be selected by purposeful sampling. Then among them, 50 nurses with moderate to severe anxiety (receiving a score above 16 based on Beck's anxiety form) will be enrolled in the available method and will be randomly divided into two groups of 25, using random cards, The experimental group received the intervention (Emotionally Effective Therapy) during eight 90-minute sessions a week for two months and two months post-treatment, Blinding description: Two-way curve In terms of group breakdown statistics, (participants, researcher, outcome assessor), both participants and researchers or outcome assessors were unaware of the allocation of study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety Syndrome, Defective Affective Cognitive System, Anxiety Symptoms.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will receive emotional efficacy-based metacognitive therapy within two months, consisting of eight weekly sessions of a 90-minute session conducted by a doctor of psychology, followed by a follow-up follow-up of 2 months. Intervention 2: Control group:  The control group does not receive any treatment (inadequate) but after a follow-up follow up a training session will be held.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Street, Basij 6, No. 22</address>
        <city>Ferdows</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9771874756</zip>
        <telephone>+98 56 3272 4277</telephone>
        <email>Mebrahimi1354@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij</address>
        <city>Ferdows</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9771874756</zip>
        <telephone>+98 56 3272 4277</telephone>
        <email>Mebrahimi1354@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 2 years of nursing experience
Minimum bachelor's degree
Clinical staff(Nurses with shifts in circulation)
Study consent
Age 25-45 years</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Psychiatric drug use
Experience stressors(Deceased first class relatives, accidental, divorce)And..
History of receiving similar intervention
Incomplete response to questionnaires
Physical complications such as limb fractures,Chronic diseases affecting behavior such as tuberculosis
Affecting mood disorderSuch as thyroid, diabetes
Severe mood disorder, such as severe depression, controlled by medication use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will receive emotional efficacy-based metacognitive therapy within two months, consisting of eight weekly sessions of a 90-minute session conducted by a doctor of psychology, followed by a follow-up follow-up of 2 months.</i_keyword>
      <i_keyword>Control group:  The control group does not receive any treatment (inadequate) but after a follow-up follow up a training session will be held.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score above 16 based on Beck Anxiety Inventory. Timepoint: At the beginning of the study before intervention. Method of measurement: Beck Anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression, Anxiety, Stress. Timepoint: Before the intervention, after the end of the intervention and two months follow up. Method of measurement: Depression, Anxiety and Stress Questionnaire DASS-21.</sec_outcome>
      <sec_outcome>Health anxiety. Timepoint: Before intervention, after intervention and two months follow up. Method of measurement: Health Anxiety Questionnaire.</sec_outcome>
      <sec_outcome>Nursing Stress. Timepoint: Before intervention, after intervention (after eight weeks), two-month follow-up. Method of measurement: Nursing Stress Questionnaire.</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: Before the intervention, after the end of the intervention (after eight weeks), two months follow-up. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Experience Avoiding. Timepoint: Before intervention, after intervention and two months follow up. Method of measurement: Acceptance and Practice Questionnaire.</sec_outcome>
      <sec_outcome>Intolerance of uncertainty. Timepoint: Before intervention, after intervention and 2 months follow up. Method of measurement: Uncertainty Intolerance Questionnaire.</sec_outcome>
      <sec_outcome>Distress Tolerance. Timepoint: Before intervention, after intervention, two-month follow-up. Method of measurement: Emotional distress tolerance questionnaire.</sec_outcome>
      <sec_outcome>Emotional Schemas. Timepoint: Before intervention, after intervention, two-month follow-up. Method of measurement: Emotional Schema Questionnaire.</sec_outcome>
      <sec_outcome>Emotional efficiency. Timepoint: Before intervention, after intervention, two-month follow-up. Method of measurement: Emotional Efficacy 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>Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-14</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Technology Research, Birjand University of Medical Sciences, Ghaffari Ave. Birjand South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
