<?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>IRCT20190619043944N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-01</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences,Deputy of Research and Technology,Neurology Research Center</primary_sponsor>
      <public_title>The Effectivenss of Acceptance and Commitment Therapy(ACT) on psychological problems in Generalized Epilepsy</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Acceptance and Commitment Therapy(ACT) on Mental Health,Death Anxiety,Quality of Life and Alpha and Beta Brain Waves  in Generalized Epilepsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40310</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: use a psychological method on neurology groups patients, Blinding description: Blinding is used in this method of the first type, and the research is one-side blind, and we dont say to patients that they are in which groups study, and it is not necessary to tell patients how many groups in the This study is there.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Generalized Epilepsy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: We perform pre-test and post-test before the treatment and then we perform a psychological treatment on our intervention group, which includes 12 sessions of treatment. Intervention 2: Control group: Here we have 12 people who have pre-test and post-tests, but there is no intervention to compare with the experimental 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:
The data obtained from the questionnaires and the Electroencephalogram(EEG) each have a score that only the individual's score in the primary variables with its secondary variables is published and does not refer to the identity of the individual.

When:
The onset of the date of access to the information is 6 months after the complete treatment and publication of the results.

To whom:
Only those who are in the field of neuroscience and neurological diseases as well as educational centers in these fields and academic fields as well as those who want to complete this plan have the right to receive data and information.

Conditions:
Researchers in the field of epilepsy and aspects affecting this neurological disease, all psychologists who seek a change in the brain wave of these individuals through with psychological approach.

Where to obtain:
Neurosurgical Center at Shafa Hospital, Kerm صan Center of Epilepsy, Referring to  neuroscience website.

How to obtain:
After 6 months of the complete process of treatment, if the person requesting the information was among the people who could provide information to him, by asking questions about the impact of this information on the scientific study process or raising his level of knowledge, Its provided to him/her,By consulting with another person who contributing in this schema .

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirhossein Mahmoodi Meymand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.102,alley.10.North Abozar Street,Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617874834</zip>
        <telephone>+34 32510696</telephone>
        <email>amirhosseinmahmoodi1995@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirhossein Mahmoodi Meymand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.102,Alley.10, North Abozar Street,Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7617874834</zip>
        <telephone>+98 34 3251 0696</telephone>
        <email>kmu.nrc@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The benchmark for entering this treatment is have generalized epilepsy
Having psychological problems mentioned
age top of 18 and under 70</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>have Mental retardation
Having a mental disorder according to medical records or any item that may interfere with learning
There is a history of drug abuse or drug dependence</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G40.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other generalized epilepsy and epileptic syndromes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: We perform pre-test and post-test before the treatment and then we perform a psychological treatment on our intervention group, which includes 12 sessions of treatment.</i_keyword>
      <i_keyword>Control group: Here we have 12 people who have pre-test and post-tests, but there is no intervention to compare with the experimental group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Grade of general health in GHQ-28 questionnaire. Timepoint: At  two section pre-test and post-test intervals that are within three months. Method of measurement: With GHQ-28 questionnaire.</prim_outcome>
      <prim_outcome>Grade of Quality of Life  especially for Epilepsy QOLIF-31-P questionnaire. Timepoint: At  two section pre-test and post-test intervals that are within three months. Method of measurement: Quality of Life questionnaire especially for Epilepsy QOLIF-31-P.</prim_outcome>
      <prim_outcome>Grade of Templer  death anxiety questionnaire. Timepoint: At  two section pre-test and post-test intervals that are within three months. Method of measurement: Templer's death anxiety questionnaire.</prim_outcome>
      <prim_outcome>Brain's alpha wavelength. Timepoint: At  two section pre-test and post-test intervals that are within three months. Method of measurement: Electroencephalogram.</prim_outcome>
      <prim_outcome>Brain's Beta wavelength. Timepoint: At  two section pre-test and post-test intervals that are within three months. Method of measurement: Electroencephalogram.</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>Kerman University of Medical Sciences,Deputy of Research and Technology,Neurology Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-21</approval_date>
        <contact_name>Kerman University of Medical Sciences,Deputy of Research and Technology,Neurology Research Center</contact_name>
        <contact_address>22 Alley, Shafa Bolivard, Kowsar Square, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
