<?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>IRCT20181019041385N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-28</date_registration>
      <primary_sponsor>The university of kurdestan</primary_sponsor>
      <public_title>Comparision of the efficacy of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders</public_title>
      <acronym></acronym>
      <scientific_title>Comparision of the efficacy of pharmacotherapy and combination of pharmacotherapy with transdiagnostic cognitive-behavior therapy on anxiety and depression symptoms in patients with emotional disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>29</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34815</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic.</study_design>
      <phase>3</phase>
      <hc_freetext>Anxiety disorders and complex depression.</hc_freetext>
      <i_freetext>Intervention 1: In the present study, participants were taking Anti-anxiety and antidepressant medication(Such as serotonin, Clonazepam, Buspirone, and venlafaxine) and also received eight sessions of transdiagnostic cognitive-behavioral therapy. Session 2: Psychological Training and Emotion Recognition. Session 3: Emotional Awareness Training.Session 4: Cognitive Assessment and Reassessment. Session 5: Emotional Avoidance (Behavior Understanding). Session 6: Emotional Behavior Behaviors (EDBs) Session 7: Exposure to Physical Sensations. Intervention 2: Control group: only anti-anxiety and anti-depressant drugs they consume.</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:
The data will be provided after it is completed.

When:
Information will be provided up to 5 months after the defense.

To whom:
Under the guidance of the supervisor, information will be provided.

Conditions:
For the scientific use and promotion of knowledge.

Where to obtain:
From the Supervisor Dr. Mehdi zemestany.

How to obtain:
Information will be provided up to 5 months after the defense.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mehdi zemestany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Seven Plateau 42, Khaneghah Alley, Keshavarz Ave.</address>
        <city>sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6619653814</zip>
        <telephone>+98 87 3323 9922</telephone>
        <email>m.zemestan@gmail.com</email>
        <affiliation>the university of kurdestan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mehdi zemestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University, Pasdaran Boulevard, Sanandaj.Iran</address>
        <city>SANANDAJ</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617715175</zip>
        <telephone>00968733664600_8 ((۲۲۴۶) داخلی)</telephone>
        <email>m.zemestan@gmail.com</email>
        <affiliation>The University of Kordestan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Anxiety Disorder and Comorbid Depression (According to Psychiatrist)
Sanandaj resident
No history of substance abuse
The desire to participate and not receive any therapeutic intervention, including psychological and medication, at least in the last year</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Has personality disorders
A history of suicide
illiterate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorders and complex depression</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the present study, participants were taking Anti-anxiety and antidepressant medication(Such as serotonin, Clonazepam, Buspirone, and venlafaxine) and also received eight sessions of transdiagnostic cognitive-behavioral therapy. Session 2: Psychological Training and Emotion Recognition. Session 3: Emotional Awareness Training.Session 4: Cognitive Assessment and Reassessment. Session 5: Emotional Avoidance (Behavior Understanding). Session 6: Emotional Behavior Behaviors (EDBs) Session 7: Exposure to Physical Sensations.</i_keyword>
      <i_keyword>Control group: only anti-anxiety and anti-depressant drugs they consume.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: pre test, post test and follow up(one month after treatment). Method of measurement: Beck Anxiety Inventory.</prim_outcome>
      <prim_outcome>Depression. Timepoint: pre test, post test and follow up(one month after treatment). Method of measurement: Beck Depression Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Emotional regulaition. Timepoint: Before and after 8 sessions of treatment. Method of measurement: Use the emotion regulation difficulty questionnaire.</sec_outcome>
      <sec_outcome>Negative repetitive thoughts. Timepoint: Before and after 8 sessions of treatment. Method of measurement: Using Negative repetitive Thought Questionnaire.</sec_outcome>
      <sec_outcome>Intolerance of Uncertainly. Timepoint: Before and after 8 sessions of treatment. Method of measurement: Use of uncertainty intolerance questionnaire.</sec_outcome>
      <sec_outcome>Anxiety Sensitivity. Timepoint: Before and after 8 sessions of treatment. Method of measurement: Anxiety Sensitivity Questionnaire.</sec_outcome>
      <sec_outcome>Experiential Avoidance. Timepoint: Before and after 8 sessions of treatment. Method of measurement: Experiential Avoidance Questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>1426565</sec_id>
        <issuing_authority>www.iranduc.ir</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The university of kurdestan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-29</approval_date>
        <contact_name>Ethics committee of University of kurdestan</contact_name>
        <contact_address>Plate 42. Alborz Golbarg Seven. Keshavar St. Khanqah St. Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
