<?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>IRCT2015121425523N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-15</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Cognitive Behavioral Group therapy's Efficacy Versus Hypnotherapy on decreasing signs of social phobia and patients' brain/behavioral systems changes.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Cognitive Behavioral Group therapy's Efficacy Versus Hypnotherapy on decreasing signs of social phobia and patients' brain/behavioral systems changes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21331</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: Experimental Group 1:&#13;
Cognitive-behavioral group therapy for social phobia&#13;
&#13;
Following Protocol is going to be used:&#13;
A Brief Cognitive-Behavioral Treatment for Social Anxiety Disorder&#13;
Eric P. Morris, David Mensink, and Sherry H. Stewart&#13;
Dalhousie University&#13;
Session 1: Following the questionnaires, introductions are made,An overview of the coming sessions is discussed and any questions were addressed,Feared Situations Questionnaire, developed by the authors, is administered, Discussion of Thoughts/Situations on the board. The board can be divided into two columns; on the left, the automatic thoughts are recorded, using examples from the class and on the right, the types of situations that elicit the thought, An introduction to how thoughts affect the subsequent physiological reactions and behaviors is presented on the board, Introduce the Vertical Arrow Technique on the board, Homework: Think about distorted thoughts you have during one anxiety provoking social situation that occurs between now and next session.&#13;
Session 2:&#13;
1) Review Homework, 2) The 10 Burns cognitive distortions are introduced, with the goal of providing the clients with examples of the types of thinking errors they were making, &#13;
3) Administer Feared Situations Questionnaire. This questionnaire was designed to provide the therapists with a better idea of which types of situations elicit the most social evaluative fear in the clients, 4) The Steps for Moderating Negative Feelings worksheet, developed by the authors, is administered, which explicitly outlines the process of identifying, analyzing, and correcting negative thoughts, Homework.&#13;
Session 3:&#13;
1) Discuss homework, 2) Continue developing automatic thoughts and replies on the board, 3) The concept of safety behaviors/cognitions is introduced with several examples provided by the therapist, Homework.&#13;
Session 4:&#13;
The purpose of this session is to talk about self esteem,To help the clients better understand the construct of self-esteem, several worksheets are administered.&#13;
Session 5 and 6:&#13;
Based on their responses from the feared situations questionnaire, a number of feared scenarios can be listed on a handout and administered to the group. This handout is given to the group to provide a few examples of the types of situations they could role play in the session.&#13;
Role plays are to be geared towards creating an anxiety provoking situation specific to the individual clients, Clients are randomly chosen to participate in a role play in front of the group, The role plays typically last approximately 10min with about 15min of preparation time, The Subjective Units of Distress (SUD) ratings are taken just prior to commencing the role play and are recorded on the board. SUD ratings are a simple tool used to provide a rough approximation of the client’s anxiety level. SUD ratings typically consist of a vertical line with “0” at the bottom and “100” at the top and clients are told that 100 is the most anxious they have been while 0 is the least anxious, Following the completion of the role play, the clients are asked about the automatic thoughts they experienced and whether they had applied any of their cognitive strategies to these thoughts. Feedback is also elicited from the group on the client’s performance (the feedback is typically positive and encouraging). Intervention 2: Experimental Group 2:&#13;
Group Hypnotherapy for social phobia&#13;
the following group will receive 4 sessions of hypnotherapy within 4 weeks and the protocol is self-structured and approved by The Iranian Scientific Society of Clinical Hypnosis.&#13;
session 1:&#13;
Administration of PMR (Progressive Muscle Relaxation) and Relaxation training, Records of the session will be given to participants for further practice as homework.&#13;
session 2:&#13;
recognition of primary symptoms, Imagery Inductions, records of session 1 and 2 will be given to participants for further practice.&#13;
session 3:&#13;
Emotional Modelling, cognitive reconstruction and behavior modification through mental visualization, conditioning, as homework records of session 1, 2 and 3 will be given to participants for further practice.&#13;
session 4:&#13;
repetition of the conditioning, repetition of 3rd session, answering participants questions, asking them for feedback.</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>Golnaz Forouzandehfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychology Department, Dr.Beheshti Hospital, Saadi St, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3354 4001</telephone>
        <email>g_forouzandehfar@yahoo.com; forouzandehfarg2@mums.ac.ir; gforouzandehfar@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohsen Dadashi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychology Department, Dr.Beheshti Hospital, Saadi St, Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 24 3354 4001</telephone>
        <email>psy.mohsen@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1.Having DSM-5 diagnostic criteria for social phobia&#13;
2.Getting psychiatric diagnosis of Social Phobia based on diagnostic interviews by Psychiatrist or Clinical Psychologist.&#13;
3. Subject's Score on SPIN questionnaire&#13;
4. Participants should not have received any treatments  6 month prior to beginning of the study.&#13;
5. participants should not received any medication one month prior to beginning of the study.&#13;
6. Participants should have a minimum age of 18 and maximum age of 50 years old.&#13;
7. Participants Should be at least on a undergraduate program.&#13;
8. Participants should agree to participation principals of the study and sign a written consent.&#13;
Exclusion criteria:&#13;
1. having a psychotic disorder and or substance abuse based on diagnostic interview.&#13;
2. having full criteria of personality disorder diagnosis on Axis II  based on  diagnostic interview.&#13;
3. Being absent for more than one session of therapy course.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social phobias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental Group 1:&#13;
Cognitive-behavioral group therapy for social phobia&#13;
&#13;
Following Protocol is going to be used:&#13;
A Brief Cognitive-Behavioral Treatment for Social Anxiety Disorder&#13;
Eric P. Morris, David Mensink, and Sherry H. Stewart&#13;
Dalhousie University&#13;
Session 1: Following the questionnaires, introductions are made,An overview of the coming sessions is discussed and any questions were addressed,Feared Situations Questionnaire, developed by the authors, is administered, Discussion of Thoughts/Situations on the board. The board can be divided into two columns; on the left, the automatic thoughts are recorded, using examples from the class and on the right, the types of situations that elicit the thought, An introduction to how thoughts affect the subsequent physiological reactions and behaviors is presented on the board, Introduce the Vertical Arrow Technique on the board, Homework: Think about distorted thoughts you have during one anxiety provoking social situation that occurs between now and next session.&#13;
Session 2:&#13;
1) Review Homework, 2) The 10 Burns cognitive distortions are introduced, with the goal of providing the clients with examples of the types of thinking errors they were making, &#13;
3) Administer Feared Situations Questionnaire. This questionnaire was designed to provide the therapists with a better idea of which types of situations elicit the most social evaluative fear in the clients, 4) The Steps for Moderating Negative Feelings worksheet, developed by the authors, is administered, which explicitly outlines the process of identifying, analyzing, and correcting negative thoughts, Homework.&#13;
Session 3:&#13;
1) Discuss homework, 2) Continue developing automatic thoughts and replies on the board, 3) The concept of safety behaviors/cognitions is introduced with several examples provided by the therapist, Homework.&#13;
Session 4:&#13;
The purpose of this session is to talk about self esteem,To help the clients better understand the construct of self-esteem, several worksheets are administered.&#13;
Session 5 and 6:&#13;
Based on their responses from the feared situations questionnaire, a number of feared scenarios can be listed on a handout and administered to the group. This handout is given to the group to provide a few examples of the types of situations they could role play in the session.&#13;
Role plays are to be geared towards creating an anxiety provoking situation specific to the individual clients, Clients are randomly chosen to participate in a role play in front of the group, The role plays typically last approximately 10min with about 15min of preparation time, The Subjective Units of Distress (SUD) ratings are taken just prior to commencing the role play and are recorded on the board. SUD ratings are a simple tool used to provide a rough approximation of the client’s anxiety level. SUD ratings typically consist of a vertical line with “0” at the bottom and “100” at the top and clients are told that 100 is the most anxious they have been while 0 is the least anxious, Following the completion of the role play, the clients are asked about the automatic thoughts they experienced and whether they had applied any of their cognitive strategies to these thoughts. Feedback is also elicited from the group on the client’s performance (the feedback is typically positive and encouraging).</i_keyword>
      <i_keyword>Experimental Group 2:&#13;
Group Hypnotherapy for social phobia&#13;
the following group will receive 4 sessions of hypnotherapy within 4 weeks and the protocol is self-structured and approved by The Iranian Scientific Society of Clinical Hypnosis.&#13;
session 1:&#13;
Administration of PMR (Progressive Muscle Relaxation) and Relaxation training, Records of the session will be given to participants for further practice as homework.&#13;
session 2:&#13;
recognition of primary symptoms, Imagery Inductions, records of session 1 and 2 will be given to participants for further practice.&#13;
session 3:&#13;
Emotional Modelling, cognitive reconstruction and behavior modification through mental visualization, conditioning, as homework records of session 1, 2 and 3 will be given to participants for further practice.&#13;
session 4:&#13;
repetition of the conditioning, repetition of 3rd session, answering participants questions, asking them for feedback.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social Phobia. Timepoint: Before intervention, after intervention, 1 month after intervention. Method of measurement: SPIN questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: before intervention, after intervention, one month after intervention. Method of measurement: DASS-21 Questionnaire.</sec_outcome>
      <sec_outcome>Physiologic symptoms of Anxiety. Timepoint: before intervention, after intervention, one month after intervention. Method of measurement: BAI Questionnaire.</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: before intervention, after intervention, one month after intervention. Method of measurement: DASS-21 Questionnaire.</sec_outcome>
      <sec_outcome>Avoidance Signs of Anxiety. Timepoint: before intervention, after intervention, one month after intervention. Method of measurement: SAD Questionnaire.</sec_outcome>
      <sec_outcome>General function. Timepoint: before intervention, after intervention, one month after intervention. Method of measurement: GAF Scale.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: before intervention, after intervention, one month after intervention. Method of measurement: WHOQOL- BREF Questionnaire.</sec_outcome>
      <sec_outcome>Brain/Behavioral System changes. Timepoint: before intervention, after intervention, one month after intervention. Method of measurement: GWPQ Questionnaire.</sec_outcome>
      <sec_outcome>Fear of negative evaluation. Timepoint: before intervention, after intervention, one month after intervention. Method of measurement: FNESB Questionnaire.</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>2016-05-04</approval_date>
        <contact_name>Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences, Jomhouri Eslami Blv, Azadi Squ, Zanjan, Iran Zanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
