<?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>IRCT20150427021965N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-08</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Title: Clinical trial of efficacy of Trans cranial direct current stimulation (TDCS) in reducing post-traumatic stress signs in military post-traumatic stress disorder</public_title>
      <acronym>TDCS</acronym>
      <scientific_title>Title: Clinical trial of efficacy of Trans cranial direct current stimulation (TDCS) in reducing post-traumatic stress signs in military post-traumatic stress disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29506</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After convenience sampling, Participants will be assigned to three groups of 20 people using closed envelopes with blocked randomization method. Blocking will be used to create the number of samples assigned to each treatment group. In this study, people will be divided into 10 blocks of 6, Blinding description: For elimination of the possibility of any bias due to the knowledge of patients or physicians evaluation of the results, and possible impact on the outcomes of research a double blind study will be performed, Participants and the evaluating investigators (except the technician that applied TDCS) 
will be blind to the intervention type.</study_design>
      <phase>3</phase>
      <hc_freetext>post-traumatic stress disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:  During treatment straight and uniform Electrical current will be sent to the brain through Cathodal type waves for up to 30 minutes. Then this group will be entered into the Sham group for 12 session. Sham group will get electrical stimulation Tran cranial direct current stimulation (TDCS) in the initial moments of each treatment session then the current will be switched off. Intervention 2: Intervention group2: Intervention group2: . Sham group will get electrical stimulation (TDCS) in the initial moments of each treatment session then the current will be switched off. In the 12 second days the treatment will be carried out in 12 consecutive sessions and straight and uniform Electrical current will be sent to the brain through Cathodal type waves for up to 30 minutes. Intervention 3: Control group:Group will not have an electrical stimulation (TDCS) of the brain.</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:
All  data will be available to researchers through contact with the designer's email.

When:
After publishing the article and analyzing the data

To whom:
After publishing the article and analyzing the data

Conditions:
Only non-analyzed data will be available to researchers.

Where to obtain:
DR Kiomars Najafi, Tooloo Specialty and subspecialty psychiatry Clinic, Rasht, Shabnam alley, in front of Area 3 municipslity, Golsar Crossroads, Rasht, Iran.
kkiomars@yahoo.com

How to obtain:
kkiomars@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Kiomars Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 khordad Avenue, Shafa Hospital, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55599</zip>
        <telephone>+98 13 3366 6268</telephone>
        <email>Kkiomars@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Kiomars Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 khordad Avenue, Shafa Hospital, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55599</zip>
        <telephone>+98 13 3366 6268</telephone>
        <email>Kkiomars@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with military post traumatic stress disorder
Age 18 to 60 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>existence of any neurological condition
low IQ
Any metal implants or instruments inside the patient’s skull or brain
Any side effect due to treatment intervention
unwillingness to participate in the study
substances- dependency to stimulants in past 6 month
patient have bipolar disorder or psychotic disorder
exacerbation of patient symptoms that need any emergency intervention or elevate in drug dose .</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder (PTSD):rises as a delayed or protracted response to a stressful event or situation (of either brief or long duration) of an exceptionally threatening or catastrophic nature, which is likely to cause pervasive distress in alm</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:  During treatment straight and uniform Electrical current will be sent to the brain through Cathodal type waves for up to 30 minutes. Then this group will be entered into the Sham group for 12 session. Sham group will get electrical stimulation Tran cranial direct current stimulation (TDCS) in the initial moments of each treatment session then the current will be switched off.</i_keyword>
      <i_keyword>Intervention group2: Intervention group2: . Sham group will get electrical stimulation (TDCS) in the initial moments of each treatment session then the current will be switched off. In the 12 second days the treatment will be carried out in 12 consecutive sessions and straight and uniform Electrical current will be sent to the brain through Cathodal type waves for up to 30 minutes.</i_keyword>
      <i_keyword>Control group:Group will not have an electrical stimulation (TDCS) of the brain.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression Score in the  Beck's Questionnaire. Timepoint: The effectiveness of the treatment will be evaluated in the twelve, twenty-four, and one-month follow-up sessions. Method of measurement: The effectiveness of the treatment will be evaluated based on the score obtained from the Beck Depression questionnaire.</prim_outcome>
      <prim_outcome>Anxiety Score in Beck's Questionnaire. Timepoint: The effectiveness of the treatment will be evaluated in the twelve, twenty-four, and one-month follow-up sessions. Method of measurement: The effectiveness of the treatment will be evaluated based on the score obtained from the Beck Anxiety questionnaire.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-25</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti Blvd,Opposite to the Sepah bank, Above Iran Radiator Representation. Building Of vice chancellor Research and Technology, Rasht, Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
