<?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>IRCT20180607040000N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-18</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of  Compassion Focused Therapy (CFT) and Acceptance and Commitment Therapy (ACT) on Social Anxiety Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  the Effectiveness of Compassion Focused Therapy (CFT) and Acceptance and Commitment Therapy (ACT) in Patients with Generalized Social Anxiety Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31733</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Considering the individuality of the treatments, each member of the sample  assigned to a group with simple randomization and through flipping a coin.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (1st): Compassion Focused Therapy (CFT) group that received 12 individual treatment sessions of one hour based on the protocol used in the study of Boersma et al. (2014). Intervention 2: Intervention group (2nd): Acceptance and Commitment Therapy (ACT) group that received 12 individual treatment sessions of one hour based on the Eifert and Forsyth protocol (2005). Intervention 3: Control group: did not receive any treatment interventions and were merely put on the 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>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>Komeil Zahedi Tajrishi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Behavioral Sciences and Mental Health, Mansouri St, Niyayesh St, Sattarkhan St, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۵۶۱۳۱۱۱</zip>
        <telephone>+98 21 6655 1657</telephone>
        <email>zahedi.komeil@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Komeil Zahedi Tajrishi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Behavioral Sciences and Mental Health, Mansouri St, Niyayesh St, Sattarkhan St, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۵۶۱۳۱۱۱</zip>
        <telephone>+98 21 6655 1657</telephone>
        <email>zahedi.komeil@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Suffering social anxiety disorder based on DSM5 diagnostic criteria (in case of other psychiatric diagnoses, SAD diagnosis should have been clearly identified as the primary diagnosis)
Age between 20-40 years
Consent to participate in the research and completing the treatment sessions
The minimum Diploma education</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering other psychiatric disorders of the first axis that are an obstacle to the treatment of Social Anxiety Disorder (e.g. Psychotic disorders, Bipolar disorder with psychotic features )
Suffering severe levels of personality disorders with serious communication problems including Schizotypal, Schizoid, Paranoid, Borderline, Antisocial, and Avoidant personality disorders
Suffering severe physical illnesses such as Cancer and AIDS, whose physical illness should be prioritized for treatment
The initiation of treatment with psychiatric drugs within the last 3 months or change of drug dose during that time.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social phobia, generalized</hc_keyword>
    </health_condition_keyword>
    <intervention_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 (1st): Compassion Focused Therapy (CFT) group that received 12 individual treatment sessions of one hour based on the protocol used in the study of Boersma et al. (2014).</i_keyword>
      <i_keyword>Intervention group (2nd): Acceptance and Commitment Therapy (ACT) group that received 12 individual treatment sessions of one hour based on the Eifert and Forsyth protocol (2005).</i_keyword>
      <i_keyword>Control group: did not receive any treatment interventions and were merely put on the waiting list.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social Anxiety Symptom. Timepoint: Before intervention, After intervention, After a follow-up period of 8 weeks. Method of measurement: Liebowitz Social Anxiety Scale (LSAS).</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before intervention, After intervention, After a follow-up period of 8 weeks. Method of measurement: World Health Organization Questionnaire of the Quality of Life (WHOQOL-BREF).</prim_outcome>
      <prim_outcome>Psychological Flexibility. Timepoint: Before intervention, After intervention, After a follow-up period of 8 weeks. Method of measurement: Acceptance and Action Questionnaire-second version (AAQ-II).</prim_outcome>
      <prim_outcome>Self Compassion. Timepoint: Before intervention, After intervention, After a follow-up period of 8 weeks. Method of measurement: Self-Compassion Scale (SCS).</prim_outcome>
      <prim_outcome>Self-Criticism. Timepoint: Before intervention, After intervention, After a follow-up period of 8 weeks. Method of measurement: Level of Self-Criticism Scale (LOSC).</prim_outcome>
      <prim_outcome>Mindfulness. Timepoint: Before intervention, After intervention, After a follow-up period of 8 weeks. Method of measurement: Ryan and Brown's Mindful Attention Awareness Scale (MAAS).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-08</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
