<?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>IRCT20181009041282N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-01</date_registration>
      <primary_sponsor>Torbate-Heidaria University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of group therapy based on acceptance and commitment with psychodrama components in people with social anxiety disorder</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of group therapy based on acceptance and commitment with psychodrama components on social anxiety, shyness and fear of negative evaluations in people with social anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34432</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: At first, 48 patients were selected through simple random sampling and then assigned to an intervention group and three control groups using the Random block split method and Randomization.com site.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Social anxiety. Condition 2: Shyness. Condition 3: Fear of negative evaluations.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group (combined psychotherapy group) received 12 sessions of 90 minutes and a weekly 2 sessions based on the protocol (based on the protocol for ACT treatment of Hayes and Strosahl and the psychodrama-Dayton protocol) that fit into social anxiety disorder, by the researcher is designed and used experimentally. Acceptance and commitment therapy (ACT) encourages a person to accept what is beyond his control and commitment to social goals. In fact, ACT uses acceptance processes, mindfulness, and change in behavior and commitment to create psychological flexibility.The psychodrama treatment protocol is a group therapy approach that highlights personality traits, interpersonal communication, psychological conflicts, and disorders of individuals through special methods of presentation. Intervention 2: Control group: The first control group at this stage will receive only ACT treatment for in 10 sessions of two hours for 10 weeks. Acceptance and commitment therapy (ACT) encourages a person to accept what is beyond his control and commitment to social goals. In fact, ACT uses acceptance processes, mindfulness, and change in behavior and commitment to create psychological flexibility. Intervention 3: Control group: The second control group at this stage will only receive the psychodrama treatment in 10 sessions of two hours for 10 weeks. The psychodrama treatment protocol is a group therapy approach that highlights personality traits, interpersonal communication, psychological conflicts, and disorders of individuals through special methods of presentation. Intervention 4: Control group: The third control group will not receive any treatment at this stage.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seddigheh Abbaspour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi street</address>
        <city>Torbat Heydarieh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9516915169</zip>
        <telephone>+98 51 5222 3118</telephone>
        <email>AbbaspourS1@thums.ac.ir</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Eshaghzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi street</address>
        <city>Torbat Heydarieh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9516915169</zip>
        <telephone>+98 51 5222 6011</telephone>
        <email>s.eshaghzadeh0@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Earn the minimum score in a Shyness Questionnaire
Earn the minimum cut score in Social Anxiety Inventory
Earn the minimum score in a questionnaire for fear of negative evaluations</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to cooperate in the study
Use of other psychological treatment
Having mental or nervous disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group (combined psychotherapy group) received 12 sessions of 90 minutes and a weekly 2 sessions based on the protocol (based on the protocol for ACT treatment of Hayes and Strosahl and the psychodrama-Dayton protocol) that fit into social anxiety disorder, by the researcher is designed and used experimentally. Acceptance and commitment therapy (ACT) encourages a person to accept what is beyond his control and commitment to social goals. In fact, ACT uses acceptance processes, mindfulness, and change in behavior and commitment to create psychological flexibility.The psychodrama treatment protocol is a group therapy approach that highlights personality traits, interpersonal communication, psychological conflicts, and disorders of individuals through special methods of presentation.</i_keyword>
      <i_keyword>Control group: The first control group at this stage will receive only ACT treatment for in 10 sessions of two hours for 10 weeks. Acceptance and commitment therapy (ACT) encourages a person to accept what is beyond his control and commitment to social goals. In fact, ACT uses acceptance processes, mindfulness, and change in behavior and commitment to create psychological flexibility.</i_keyword>
      <i_keyword>Control group: The second control group at this stage will only receive the psychodrama treatment in 10 sessions of two hours for 10 weeks. The psychodrama treatment protocol is a group therapy approach that highlights personality traits, interpersonal communication, psychological conflicts, and disorders of individuals through special methods of presentation.</i_keyword>
      <i_keyword>Control group: The third control group will not receive any treatment at this stage.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social Phobia: Refers to the obvious and continuous fear of social and functional situations that results in a negative evaluation of the participation in communication situations and can lead to the remoteness and separation of the individual from the community. Timepoint: The beginning of the study and after the intervention. Method of measurement: Social Phobia Inventory.</prim_outcome>
      <prim_outcome>Shyness : The tendency to avoid social interactions and feelings of failure are called proper participation in shyness social situations. Timepoint: The beginning of the study and after the intervention. Method of measurement: Stanford Shyness Questionnaire.</prim_outcome>
      <prim_outcome>Fear of negative evaluation: The feeling of apprehension and concern about others' assessments is the concern raised by these negative assessments, expectations and expectations that a person is about others and that others will only judge him negatively, Gets. Timepoint: The beginning of the study and after the intervention. Method of measurement: Fear of Negative Evaluation Scale.</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>Torbate-Heidaria University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-24</approval_date>
        <contact_name>Ethics Committee of Torbat Heydarieh University of Medical Sciences</contact_name>
        <contact_address>Razi street Torbat Heydarieh Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
