<?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>IRCT20220502054725N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-17</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigation of the Effectiveness of Cognitive Behavioral Therapy with Eye Movement Desensitization and Reprocessing Therapy in Teenager with Social Anxiety Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the Effectiveness of Cognitive Behavioral Therapy with Eye Movement Desensitization and Reprocessing Therapy on Anxiety Sensitivity, Fear of Negative Evaluation, Social Self-Efficacy and Quality of Life in Teenager with Social Anxiety Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63378</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will run by using the Software Allocation Random. Since the total number of samples predicted for the present study is small (n=45), we will use the simple randomization method to assign subjects to three study groups. We will assign a unique number to every member of our study's sample (from 1 to 45). An independent researcher makes random allocation codes using computer-generated random numbers. Then, we will use the random allocation generator software to randomly assign each number to experimental (CBT and EMDR) and control groups, Blinding description: This study is a single-blind study in that the researcher and participants are aware of the allocating intervention, but the data analyst and the person conducting the assessments will be blind to the specific participant’s group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social phobias.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive-behavioral therapy: In the present study, twelve 60-minute sessions of cognitive-behavioral therapy weekly according to the standard protocol of cognitive-behavioral therapy for social anxiety disorder. Intervention 2: Intervention group: Eye Movement Desensitization and Reprocessing Therapy: In the present study, eight 90-minute sessions of eye movement desensitization and reprocessing therapy weekly according to the standard protocol of cognitive-behavioral therapy for social anxiety disorder.</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:
Data from participants' responses to anxiety sensitivity, fear of negative evaluation, social self-efficacy, quality, and social anxiety disorder  questionnaires in pre-test, post-test and follow up will analyze using SPSS software, and the results, without mentioning the names of the participants, were shared as study results.

When:
The access period starts 6 months after the results are published.

To whom:
The data of this study will be available only to researchers working in academic and scientific institutions.

Conditions:
The data of this study will be provided for use by researchers in review or comparative studies.

Where to obtain:
Farnaz Moghbeli, Department of Psychology, Islamic Azad University, Boroujerd Branch, Iran. f.moghbeli71@gmail.com, +989163992924

How to obtain:
The applicant provides information about their application via email. Up to two weeks after the request, if accepted, documents or data files will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farnaz Moghbeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Navab Square, 3 km of Yadegar Imam Road, Imam Khomeini University Complex, Boroujerd, Iran.</address>
        <city>Boroujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6915136335</zip>
        <telephone>+98 66 4251 8000</telephone>
        <email>f.moghbeli71@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Bahrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Navab Square, 3 km of Yadegar Imam Road, Imam Khomeini University Complex, Boroujerd, Iran.</address>
        <city>Boriujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6915136335</zip>
        <telephone>+98 66 4251 8000</telephone>
        <email>bahrami.psyco@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having suicidal thoughts and beliefs
More than 2 absence in treatment sessions</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A SPIN greater score than or equal to 20
Fulfilling all diagnostic criteria of social phobia based on the SCID-5
Providing written informed consent for participation in the study by participants and their parents
No presence of any other mental disorders
No history of mental illness
No dependence on alcohol or drugs
Do not receive other current psychological treatment
Age between 14 - 18</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cognitive-behavioral therapy: In the present study, twelve 60-minute sessions of cognitive-behavioral therapy weekly according to the standard protocol of cognitive-behavioral therapy for social anxiety disorder.</i_keyword>
      <i_keyword>Intervention group: Eye Movement Desensitization and Reprocessing Therapy: In the present study, eight 90-minute sessions of eye movement desensitization and reprocessing therapy weekly according to the standard protocol of cognitive-behavioral therapy for social anxiety disorder.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety sensitivity: Fear of anxiety which are related to their thoughts. Timepoint: One week before the intervention, one week after the last intervention session, one month after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Fear of negative evaluation: It means fear, worry and avoidance of being judged negatively by others. Timepoint: One week before the intervention, one week after the last intervention session, one month after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Social self-efficacy: refers to a person's self-confidence about his or her ability to behave in a certain way that leads to a favorable perception of oneself in others. Timepoint: One week before the intervention, one week after the last intervention session, one month after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Quality of Life: an individual's perception of their position in life in the context of the culture and value systems. Timepoint: One week before the intervention, one week after the last intervention session, one month after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive-behavioral therapy: In the present study, twelve 60-minute sessions of cognitive-behavioral therapy weekly according to the standard protocol of cognitive-behavioral therapy for social anxiety disorder. Timepoint: In each treatment session. Method of measurement: Behavior.</sec_outcome>
      <sec_outcome>Eye Movement Desensitization and Reprocessing Therapy: In the present study, eight 90-minute sessions of eye movement desensitization and reprocessing therapy weekly according to the standard protocol of cognitive-behavioral therapy for social anxiety disorder. Timepoint: In each treatment session. Method of measurement: Behavior.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-19</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University - Boroujerd Branch</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. Boroujerd Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
