<?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>IRCT20171102037181N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-21</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy of Neurofeedback treatment on  Anxiety</public_title>
      <acronym>NT</acronym>
      <scientific_title>Efficacy of QEEG Guided Neurofeedback treatment on decreasing symptoms and signs of Generalized Anxiety Disorder   and emotion regulation strategies.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28599</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Generalized Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention group: 15 subjects will be treated on the basis of QEEG-based neurofeedback training, and 15 subjects will not receive any intervention in the control group, and individual treatment will be followed for subjects in the QEEG-based neurofeedback treatment 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is In the consent form, personal information will be confidential and the data will be published by the general and a group of members.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hasan Abdiyan Kalibar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eastern Side of Shahid Beheshti Hospital-Ork Gate</address>
        <city>zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>56184- 45139</zip>
        <telephone>+98 24 3354 2401</telephone>
        <email>h.abdiyan25@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hasan Abdiyan Kalibar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Eastern Side of Shahid Beheshti Hospital-Ork Gate</address>
        <city>zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>56184- 45139</zip>
        <telephone>+98 24 3354 2401</telephone>
        <email>h.abdiyan25@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having DSM-5 diagnostic criteria for generalized anxiety disorder diagnosed by a psychiatrist based on diagnostic interview and clinical psychologist; as well as on the basis of the 7-item GAD-7 questionnaire and DSM-5 Clinical Interview for generalized Anxiety Disorder
At least 18 years and maximum 50 years
Study at one of the academic levels
Patient agrees to participate in research and sign a written consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering Psychotic disorder And Substance Abuse Based on Diagnostic Interview.
Not receiving psychological treatment at least 6 months before entering the research.
No drug use at least one month before entering the research.
Having complete criteria for personality disorder in axis II based on diagnostic interview.
The apparent risk of suicide is now.
Having more than two absentee sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 15 subjects will be treated on the basis of QEEG-based neurofeedback training, and 15 subjects will not receive any intervention in the control group, and individual treatment will be followed for subjects in the QEEG-based neurofeedback treatment group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of the signs and symptoms of generalized anxiety disorder. Timepoint: The effect of neurofeedback treatment in patients with generalized anxiety disorder before, after and three months after treatment. Method of measurement: The score that the subject gained from the GAD-7 questionnaire is the GAD-7. This scale has been developed to diagnose anxiety disorder and to measure the severity of clinical symptoms.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Emotional regulation. Timepoint: Evaluating the improvement of emotional regulation strategies before, after and three month following the treatment of neurofeedback. Method of measurement: The score for the subject of the Emotional Regulation Strategies Questionnaire (ERQ; Grass &amp; John, 2003) was designed to evaluate two emotion regulation strategies, including suppression and re-evaluation. This questionnaire has 10 sentences.</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: Evaluation before, after, and in the following three months. Method of measurement: The score that the subject obtained from the Depression, Anxiety and Stress Questionnaire (DASS).</sec_outcome>
      <sec_outcome>Depending on the DSM-5 criteria, depression involves a number of disorders that all agree on three types of symptoms: mood symptoms that include: feeling sad, empty, worrying and irritable. Vegetative symptoms that include fatigue, social deprivation and diabetes. Disturbances in appetite (depression or increased sleep) are also common. The cognitive symptoms of these disorders include centralized problems, difficulty in resolving, low self confidence, negative thoughts about oneself, the world, and others, and guilty and suicidal ideation. Timepoint: Evaluation before, after, and in the following three months. Method of measurement: The score that the subject obtained from the Depression, Anxiety and Stress Questionnaire (DASS).</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-11</approval_date>
        <contact_name>Zanjan University of Medical Sciences Ethics Committee.</contact_name>
        <contact_address>Central Station of Zanjan University of Medical Sciences-Beginning of the Islamic Republic Boulevard-Azadi Square. zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
