<?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>IRCT2012103011328N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-12-09</date_registration>
      <primary_sponsor>Tehran University of Medical Science</primary_sponsor>
      <public_title>Effectiveness of psychotherapy in the treatment of social phobia</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of short-term psychodynamic psychotherapy versus Sertraline in reducing the symptoms of social phobia in Tehran University students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11592</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>social phobia.</hc_freetext>
      <i_freetext>Intervention 1: The medication group were treated with Sertraline  for 12 weeks. Sertraline was started at a dose of 50 mg and was added to it 50 mg per week until reached into maximum dose of 200 mg over 4 weeks. Treatment continued for eight weeks with a dose of 200 mg per day. Treatment was conducted by a psychiatrist. Intervention 2: Waiting list group did not receive treatment for eight weeks and were evaluated only 4 times. Intervention 3: Psychodynamic psychotherapy intervention group received 21 sessions (in addition to the primary and final evaluations and termination). Individual psychotherapy sessions were held twice per week, each session lasting 45 minutes. Psychodynamic interventions were performed based on McCullough’s treatment Manual. This type of treatment was composed of three main parts: defenses restructuring, affect restructuring and restructuring of sense of self/others.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehryar nader Mohammadi moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1,  Shahid Mansouri Alley, niayesh St, Sattarkhan Ave, Postal Code: 1445613111 POBox: 441 to 145</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1443813444</zip>
        <telephone>+98 21 6655 1515</telephone>
        <email>m-nadermohammadi@razi.tums.ac.ir</email>
        <affiliation>Tehran psychiatric institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Kazem Atef Vahid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1,  Shahid Mansouri Alley, niayesh St, Sattarkhan Ave, Postal Code: 1445613111 POBox: 441 to 145</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1443813444</zip>
        <telephone>+98 21 6655 1655</telephone>
        <email>kazemv@yahoo.com</email>
        <affiliation>Tehran university of medical science , Tehran psychiatric institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  having social phobia criteria based on the SCID; SPIN score greater than or equal to 24; age between 18 to 50 years;&#13;
Exclusion criteria: psychotic disorders; obsessive - compulsive disorder; bipolar disorder; organic brain injury; addiction to drugs and alcohol; impaired impulse control; Cluster A and B  personality disorders; disorder on Axis III; history of attempt and suicidal ideation; history of violent behavior; psychotherapy for social phobia over the last 6 months;  If there are any other psychotic disorders (except stated in the first clause), primary complaint is not symptoms of social phobia.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>ّF40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fear of scrutiny by other people leading to avoidance of social situations. More pervasive social phobias are usually associated with low self-esteem and fear of criticism. They may present as a complaint of blushing, hand tremor, nausea, or urgency of mi</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The medication group were treated with Sertraline  for 12 weeks. Sertraline was started at a dose of 50 mg and was added to it 50 mg per week until reached into maximum dose of 200 mg over 4 weeks. Treatment continued for eight weeks with a dose of 200 mg per day. Treatment was conducted by a psychiatrist.</i_keyword>
      <i_keyword>Waiting list group did not receive treatment for eight weeks and were evaluated only 4 times.</i_keyword>
      <i_keyword>Psychodynamic psychotherapy intervention group received 21 sessions (in addition to the primary and final evaluations and termination). Individual psychotherapy sessions were held twice per week, each session lasting 45 minutes. Psychodynamic interventions were performed based on McCullough’s treatment Manual. This type of treatment was composed of three main parts: defenses restructuring, affect restructuring and restructuring of sense of self/others.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of symptoms of social phobia- clinician rating. Timepoint: The psychotherapy  Group at weeks 1, 8, 15, 23 and the medication group at weeks 1, 4, 8, 12, and the waiting list group at weeks1, 4, 6, 8. Method of measurement: clinical global impression - severity.</prim_outcome>
      <prim_outcome>Severity of symptoms of social phobia- Patient rating. Timepoint: The  psychotherapy  Group at weeks 1, 8, 15, 23 and  the medication group at weeks 1, 4, 8, 12, and the waiting list group at weeks1, 4, 6, 8. Method of measurement: social phobia inventory (SPIN).</prim_outcome>
      <prim_outcome>Improvement rate in symptoms of social phobia. Timepoint: The psychotherapy group at weeks 8, 15, 23 and the medication group at weeks 4, 8, 12, and the waiting list group at weeks 4, 6, 8. Method of measurement: Using the Clinical Global Impression of Improvement scale, CGI-I.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Global Function. Timepoint: the Psychotherapy group at weeks 1, 23 and the medication group at weeks 1, 12 and the waiting list group at weeks1, 8. Method of measurement: Using the GAF Scale to assess the global functioning.</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>Tehran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-10-20</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Science, Sixth Floor, Ghods St,  Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
