<?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>IRCT20180421039369N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-16</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The assessment of acceptance and commitment therapy on social anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The efficacy of acceptance and commitment therapy in improving psychological symptoms in patients with social anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31343</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomizing assignment, the Simple Random method is used. 24 cards with the same appearance are provided. On 12 of cards the number 1 and on 12 of them the number 2 is written which represent the intervention group and the control group respectively. Then, one card is given to each qualified individual randomly and his assignment to the group is recorded. This process is continues until all individuals are assigned. It should be noted that participants are unaware of the nature of the numbers and type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social phobias.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the intervention group consists of 12 individuals during the 12 sessions receiving Treatment based on acceptance and commitment individually according to eifert and forsyth protocol. This treatment has two main objectives: 1) Enhancing the power of accepting unpleasant thoughts and feelings that the patient does not have control over their existence or disappearance. 2) Commitment and action towards the kind of life that is valuable to him. In this treatment the concepts of acceptance, commitment, values and exposure to anxiety are trained and treatment sessions are held weekly and each session lasts 90 minutes during three months. After that, the follow-up period takes two months. Intervention 2: Control group: consists of 12 people who are waiting in the waiting list and do not receive treatment during the time of intervention. but after treatment, they will receive acceptance and commitment treatment for maintaining the ethics of the control group.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samad Khoramnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 84 3442 3968</telephone>
        <email>khoramniya.samad@369.gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samad Khoramnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 84 3442 3968</telephone>
        <email>khoramniya.samad.369@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The main and primary diagnosis of social anxiety disorder based on anxiety disorder interview
Patient's agreement to participate in research
Lack of psychological therapy in the last year
No psychiatric medication intake during the past six months
No main and primary diagnosis of mood disorders and other anxiety disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Current diagnosis of any comorbid mental disorders in Axis 1 and 2 based on a psychiatrist's diagnostic interview
History of current substance dependence and over a year before the onset of treatment</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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the intervention group consists of 12 individuals during the 12 sessions receiving Treatment based on acceptance and commitment individually according to eifert and forsyth protocol. This treatment has two main objectives: 1) Enhancing the power of accepting unpleasant thoughts and feelings that the patient does not have control over their existence or disappearance. 2) Commitment and action towards the kind of life that is valuable to him. In this treatment the concepts of acceptance, commitment, values and exposure to anxiety are trained and treatment sessions are held weekly and each session lasts 90 minutes during three months. After that, the follow-up period takes two months.</i_keyword>
      <i_keyword>Control group: consists of 12 people who are waiting in the waiting list and do not receive treatment during the time of intervention. but after treatment, they will receive acceptance and commitment treatment for maintaining the ethics of the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social phobia. Timepoint: A week before the intervention, one week after the intervention, two months after the intervention. Method of measurement: Spin social anxiety questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>External shame. Timepoint: A week before the intervention, one week after the intervention, two months after the intervention. Method of measurement: External shame questionnaire.</sec_outcome>
      <sec_outcome>Self-compassion. Timepoint: A week before the intervention, one week after the intervention, two months after the intervention. Method of measurement: Self compassion questionnaire.</sec_outcome>
      <sec_outcome>Acceptance and action. Timepoint: A week before the intervention, one week after the intervention, two months after the intervention. Method of measurement: Acceptance  and Action Questionnaire.</sec_outcome>
      <sec_outcome>Difficult emotion regulation. Timepoint: A week before the intervention, one week after the intervention, two months after the intervention. Method of measurement: Difficult emotion regulation scale.</sec_outcome>
      <sec_outcome>Interpersonal sensitivity. Timepoint: A week before the intervention, one week after the intervention, two months after the intervention. Method of measurement: Interpersonal Sensitivity 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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-21</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
