<?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>IRCT20100614004178N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-26</date_registration>
      <primary_sponsor>Shelir Kolahzari</primary_sponsor>
      <public_title>The Efficacy of  Unified Transdiagnostic Therapy in Reducing Worry, Anxiety, Depressive Sympotom and Emotion Regulation in Patients With Generalized Anxiety Disorder</public_title>
      <acronym></acronym>
      <scientific_title>The Efficacy of  Unified Trans diagnostic Therapy in Reducing Worry, Anxiety, Depressive Sympotom and Emotion Regulation in Patients With Generalized Anxiety Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30595</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be divided into two experimental and control groups using simple random sampling using sealed envelopes. This will provide 20 envelopes with 10 letters on the letter A (the intervention group) and 10 letters on the cards B (control group) and put in the envelope. The envelopes will be mixed together and randomly one of the envelopes will be selected by the patient and assigned to one of the groups accordingly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Generalized Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: En Experimental was participated in transdiagnostic therapy at 8-12 weeks for 1 hours. Therapeutic components of transdiagnostic therapy were including: home work, Positive and Negative Feedback, Summary, Three-System Thriller Model, Emotional Components, Cognitive Distortions, Automatic Thoughts, Ingection PracticeThinking, Downward Arrow, Dysfunctional Attitude Classification, LogicalAnalysis, Analysis of the Utility of Beliefs./ Pre-test and finally post-test were performed on the experimental group. Intervention 2: Control group: In the control group, there was no intervention,Pre-test and post-test were performed on 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 dissemination of patient information is not necessary</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shelir Kolahzari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharif Abad St.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617934584</zip>
        <telephone>+98 87 3362 6183</telephone>
        <email>shelir.kolahzari@gmail.com</email>
        <affiliation>Shelir Kolahzari</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shelir Kolahzari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharif Abad St.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617934584</zip>
        <telephone>+98 87 3362 6183</telephone>
        <email>Shelir.kolahzari@gmail.com</email>
        <affiliation>Kurdestan University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being resident in sanandaj)
Having generalized anxiety disorder symptoms based on psychiatric or clinical psychologists diagnosis according to SCID-1
Having motivation and satisfaction for attending in treatment sessions
level of education :Having at least high school diploma</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>diagnosis of any comorbid disorders except for anxiety and depression which has been mentioned in the research
having major depressive disorder (MDD)
having psychotic symptoms and drug abuse and suicidal thoughts
having all symptoms of personality disorders according to DSM-5</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</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>Intervention group: En Experimental was participated in transdiagnostic therapy at 8-12 weeks for 1 hours. Therapeutic components of transdiagnostic therapy were including: home work, Positive and Negative Feedback, Summary, Three-System Thriller Model, Emotional Components, Cognitive Distortions, Automatic Thoughts, Ingection PracticeThinking, Downward Arrow, Dysfunctional Attitude Classification, LogicalAnalysis, Analysis of the Utility of Beliefs./ Pre-test and finally post-test were performed on the experimental group</i_keyword>
      <i_keyword>Control group: In the control group, there was no intervention,Pre-test and post-test were performed on control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in beck anxiety inventory. Timepoint: pre and post treatment and after 1month follow up. Method of measurement: beck depression inventory 2, beck anxiety inventory,.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: pre and post treatment and after 3 month fallow up. Method of measurement: Beck anxiety inventory.</sec_outcome>
      <sec_outcome>Depression. Timepoint: pre and post treatment and after 3 month fallow up. Method of measurement: beck depression inventory.</sec_outcome>
      <sec_outcome>Woryy. Timepoint: pre and post treatment and after 3 month fallow up. Method of measurement: Pennsylvania worry questionnaire.</sec_outcome>
      <sec_outcome>Emotion regulation. Timepoint: pre and post treatment and after 3 month fallow up. Method of measurement: difficulties in emotion regulation 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>Shelir Kolahzari</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-01</approval_date>
        <contact_name>Ethics Committee of Kurdestan University of Medical Sciences</contact_name>
        <contact_address>Ave.,Nahid4.,Street Sharifabad Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
