<?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>IRCT20171228038109N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-10</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>"Evaluating Effectiveness of Group Behavioral Activation Therapy;Drug Therapy and Combined Therapy on Social Anxiety Disorder"</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Group Behavioral Activation Therapy; Drug Therapy and Combination  Therapy on Clinical Signs (Anxiety and Depression), Negative Evaluation and Quality of Life in Patients with Social Anxiety Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31004</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were selected in a targeted manner with a Diagnostic Interview according  to DSM-V criteria and Spin Anxiety questionnaire score  and randomly selected by two-way blind lottery in groups, Blinding description: The participants and the researcher did not know the division of the members into the groups and the participants were assigned to groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Social Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Combined behavioral group activation therapy by taking placebo: The behavioral group therapy trend in group sessions were held for the experimental group based on Menal Guelan, during of sessions, which the basic principles of behavioral activation, the recording of their daily activities program within a week, And its application in the face of avoiding enjoyable and mastering activities and And tabulating these activities and  assessing skills, choosing, examining, joining, observing results, never give up too. Also, motivation skills, responsiveness, appropriate alternatives, coping methods and overcome stimuli, responses, avoidance patterns, self-esteem skills, self-expression, and courageous training and discussion. Intervention 2: Intervention group: Group supportive treatment with paroxetine. Each of the participants in the drug treatment group took paroxetine seven times a week. According to psychiatrist, for avoiding side effects, three to four days in the first week, they took half a dozen paroxetine at night. Also, throughout the course of treatment, the contact numbers were given to the participants to contact and notify in case of possible side effects. Except for drowsiness in the first nights of taking medication, no particular complications were reported. were reported. Intervention 3: Intervention group: Combined behavioral group activation therapy with paroxetine. In combined group therapy, behavioral activation therapy was performed according to the behavioral activation group therapy guidelines that described in the behavioral therapy intervention, simultaneously with the treatment of a daily dose of paroxetine. Intervention 4: Control group: Waiting list.</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 The information of the clients is confidential and its controversy with secrecy in the context of psychotherapy is contradictory</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mahdi Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebnesina Hospital</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0938131877</zip>
        <telephone>+98 51 3700 2317</telephone>
        <email>amiri.psy@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Elham Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebnesina Haspital</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0938131877</zip>
        <telephone>+98 51 3700 2317</telephone>
        <email>elhamtaheri85@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Social anxiety disorder based on diagnostic interview ( DSM-V )
Residence in Mashhad at the time of meeting group therapy
Degree higher than diploma
age between 18 to 40 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a specific axis of disorder by using a structured interview for DSM-V mental disorders
Having a disabling physical illness that,it is possibile to make problem for group research
Being under the psychological or Medical treatment at the same time as research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F93.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social anxiety disorder of childhood</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Combined behavioral group activation therapy by taking placebo: The behavioral group therapy trend in group sessions were held for the experimental group based on Menal Guelan, during of sessions, which the basic principles of behavioral activation, the recording of their daily activities program within a week, And its application in the face of avoiding enjoyable and mastering activities and And tabulating these activities and  assessing skills, choosing, examining, joining, observing results, never give up too. Also, motivation skills, responsiveness, appropriate alternatives, coping methods and overcome stimuli, responses, avoidance patterns, self-esteem skills, self-expression, and courageous training and discussion.</i_keyword>
      <i_keyword>Intervention group: Group supportive treatment with paroxetine. Each of the participants in the drug treatment group took paroxetine seven times a week. According to psychiatrist, for avoiding side effects, three to four days in the first week, they took half a dozen paroxetine at night. Also, throughout the course of treatment, the contact numbers were given to the participants to contact and notify in case of possible side effects. Except for drowsiness in the first nights of taking medication, no particular complications were reported. were reported.</i_keyword>
      <i_keyword>Intervention group: Combined behavioral group activation therapy with paroxetine. In combined group therapy, behavioral activation therapy was performed according to the behavioral activation group therapy guidelines that described in the behavioral therapy intervention, simultaneously with the treatment of a daily dose of paroxetine.</i_keyword>
      <i_keyword>Control group: Waiting list</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social Anxiety Scale with Spin Questionnaire. Timepoint: Pre-test, post-test, follow-up. Method of measurement: Spin Social Anxiety Scale (2000).</prim_outcome>
      <prim_outcome>Depression Scale with Beck Questionnaire. Timepoint: Pre-test, post-test, follow-up. Method of measurement: Beck Depression Inventory.</prim_outcome>
      <prim_outcome>Fear of Negative Assessment with Wilson &amp; Rappi's Consequences of Social Incidents (2005). Timepoint: Pre-test, post-test, follow-up. Method of measurement: Wilson &amp; Rappi's Consequences of Social Incidents (2005).</prim_outcome>
      <prim_outcome>Quality of Life Score with the World Health Organization Short Life Style Quality Scale (1989). Timepoint: Pre-test - Post-test - Follow up. Method of measurement: World Health Organization Quality of Life Scale (1989).</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-10</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ebnesina Hospital Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
