<?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>IRCT20220502054728N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effectiveness of Transdiagnostic treatment and Cognitive-behavioral therapy on Generalized anxiety disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Transdiagnostic treatment and Cognitive-behavioral therapy on Emotional regulation, Depressive symptoms, Anxiety and Social adjustment of adolescents with Generalized anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63361</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will run by using the Software Allocation Random. 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 groups and control groups, Blinding description: The study was single blind. The patients in three groups (cognitive-behavioral therapy and integrated meta-diagnostic therapy and control group) did not know about the type of intervention that was performed. Also, 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>Generalized anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: transdiagnostic treatment: In the present study, twelve 60-70 minute sessions (two sessions per week) of transdiagnostic treatment, according to the standard protocol of transdiagnostic treatment for generalized anxiety disorder (Barlow and Durand, 2011), will be used in the form of group counseling sessions. Intervention 2: Intervention group: cognitive-behavioral therapy: In the present study, twelve 60-70 minute sessions (two sessions per week) of cognitive-behavioral therapy, according to the standard protocol of transdiagnostic treatment for generalized anxiety disorder (Dagas and Robichaud, 2012; translation: Akbari, Cheiniforoshan and Abedi, 2015), will be used in the form of group counseling sessions.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahmoud Reza Sharfi</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 3343 2180</telephone>
        <email>sharafipsychology@gmail</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Davood Jafari</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>4765815615</zip>
        <telephone>+98 66 4251 8000</telephone>
        <email>davood_jafari5361@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All adolescent referring to Khorram Abad counseling centers
Fulfilling all diagnostic criteria of generalized anxiety disorder 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</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having suicidal thoughts and beliefs
Diagnosis of other mental disorders
Declining to participate in therapy sessions</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: transdiagnostic treatment: In the present study, twelve 60-70 minute sessions (two sessions per week) of transdiagnostic treatment, according to the standard protocol of transdiagnostic treatment for generalized anxiety disorder (Barlow and Durand, 2011), will be used in the form of group counseling sessions.</i_keyword>
      <i_keyword>Intervention group: cognitive-behavioral therapy: In the present study, twelve 60-70 minute sessions (two sessions per week) of cognitive-behavioral therapy, according to the standard protocol of transdiagnostic treatment for generalized anxiety disorder (Dagas and Robichaud, 2012; translation: Akbari, Cheiniforoshan and Abedi, 2015), will be used in the form of group counseling sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotion regulation: the score obtained by the Cognitive Regulation of Emotion Questionnaire (CERQ) (Garnefsky and Kraij, 2006). Timepoint: One week before the intervention, one week after the last intervention session, three month after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Depression: the score obtained by the subjects of the sample group in the depression sub-scale of the depression, anxiety, and stress scale (DASS-21) (Lavibond and Lavibond, 1995). Timepoint: One week before the intervention, one week after the last intervention session, three month after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety: the score obtained by the subjects of the sample group in the anxiety sub-scale of the depression, anxiety, and stress scale (DASS-21) (Lavi Band and Lavi Band, 1995). Timepoint: One week before the intervention, one week after the last intervention session, three month after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Social adjustment: the score obtained by the subjects of the sample group in the social adjustment sub-scale of the student adjustment questionnaire (Sinha and Singh, 1993). Timepoint: One week before the intervention, one week after the last intervention session, three month after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Transdiagnostic Treatment: Including twelve 60-70 minute sessions (two sessions per week) of transdiagnostic treatment, according to the standard protocol of transdiagnostic treatment for generalized anxiety disorder, in the form of group counseling sessions. Timepoint: In each treatment session. Method of measurement: Behavior.</sec_outcome>
      <sec_outcome>Cognitive-behavioral therapy: Including 60-70 minute sessions (two sessions per week) of cognitive-behavioral therapy, according to the standard protocol of cognitive-behavioral therapy for generalized anxiety disorder, in the form of group counseling sessions. 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>2022-04-20</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University - Boroujerd Branch</contact_name>
        <contact_address>Imam Khomeini University Complex, 3 km Yadgar Imam Road, Nawab Square, Borujerd Boroujerd Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
