<?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>IRCT20220421054607N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-19</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The Synergistic effect of  Transcranial direct current stimulation   (tDCS)   with cognitive behavioral therapy (CBT) in patients with social phobia disorder</public_title>
      <acronym></acronym>
      <scientific_title>The Synergistic effect of  Transcranial direct current stimulation (tDCS) with cognitive behavioral therapy (CBT) on social anxiety, depression, emotion regulation, quality of life, EEG,  attention bias in patients with social phobia disorder: randomize clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63119</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Samples are assigned after screening using Excell program in three groups of treatment number 1, treatment number 2 and sham so that all participants have an equal chance to participate in the groups, Blinding description: None of the subjects will know about randomization and the group assignment process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>SOCIAL ANXIETY DISORDER.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Transcranial electrical stimulation for five days. Two sessions every day. Each session is twenty minutes and cognitive-behavioral therapy for fifteen to twenty sessions. Intervention 2: Intervention group 2: Transcranial electrical stimulation for five days. Two sessions every day. Each session is twenty minutes. Intervention 3: Control group: Sham cranial electrical stimulation and cognitive-behavioral therapy  for fifteen to twenty sessions.</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:
By observing the data encoding, the whole data can be shared for the unidentifiable people.

When:
Access period starts 6 months after the results are published

To whom:
All researchers

Conditions:
Allowed for research applications

Where to obtain:
Prinaz Sadat Amiri
Email: ami. parinaz 399@gmail.com

How to obtain:
One Month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Prinaz Sadat Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Beheshti Hospital, Ark square</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45136-15788</zip>
        <telephone>+98 24 3353 3400</telephone>
        <email>ami.parinaz399@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prinaz Sadat Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Beheshti Hospital, Ark square</address>
        <city>zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45136-15788</zip>
        <telephone>+98 21 4454 2403</telephone>
        <email>ami.parinaz399@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering social anxiety disorder
Willingness to participate in research
Age range minimum 18 and maximum 50 years old
Non-smoker
At least third junior high school
No severe psychiatric disorders such as psychotic disorders, cognitive disorders and other psychiatric disorders
Lack of history of epileptic seizures and history of head injury
No metal device or other electrical device in the head
Do not consume drugs and alcohol
Not receiving psychological and technological treatments at least one month before entering the research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence for more than two sessions
Suicidal ideation during intervention sessions
The need for crisis-related interventions such as medication during intervention sessions
Cancel continuation of intervention sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Transcranial electrical stimulation for five days. Two sessions every day. Each session is twenty minutes and cognitive-behavioral therapy for fifteen to twenty sessions</i_keyword>
      <i_keyword>Intervention group 2: Transcranial electrical stimulation for five days. Two sessions every day. Each session is twenty minutes</i_keyword>
      <i_keyword>Control group: Sham cranial electrical stimulation and cognitive-behavioral therapy  for fifteen to twenty sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social anxiety. Timepoint: Before intervention and immediately after intervention and three months after intervention. Method of measurement: Liebowitz Social Anxiety Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: Before intervention and immediately after intervention and three months after intervention. Method of measurement: Beck Depression Inventory-II.</sec_outcome>
      <sec_outcome>Emotion regulation. Timepoint: Before intervention and immediately after intervention and three months after intervention. Method of measurement: Difficulties in Emotion Regulation Scale.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Before intervention and immediately after intervention and three months after intervention. Method of measurement: WHOQUL questionnaire.</sec_outcome>
      <sec_outcome>Attentional bias. Timepoint: Before intervention and immediately after intervention and three months after intervention. Method of measurement: Attentional bias task.</sec_outcome>
      <sec_outcome>Worry. Timepoint: Before intervention and immediately after intervention and three months after intervention. Method of measurement: Penn State Worry Questionnaire.</sec_outcome>
      <sec_outcome>Asymmetry of brain waves. Timepoint: Before intervention and immediately after intervention and three months after intervention. Method of measurement: Electroencephalography.</sec_outcome>
      <sec_outcome>Coherence of brain waves. Timepoint: Before intervention and immediately after intervention and three months after intervention. Method of measurement: QEEG.</sec_outcome>
      <sec_outcome>Amplitude of brain waves. Timepoint: Before intervention and immediately after intervention and three months after intervention. Method of measurement: QEEG.</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>2022-04-20</approval_date>
        <contact_name>Ethics committee of  Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences,12th St.,Karmandan Town Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
