<?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>IRCT20200216046515N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-18</date_registration>
      <primary_sponsor>Allameh Tabatabai University</primary_sponsor>
      <public_title>The  Effectiveness  of  Schema Therapy on Treatment of  Chronic Panic Disorder</public_title>
      <acronym></acronym>
      <scientific_title>The  Effectiveness  of  Schema Therapy on Reducing Signs of people with Chronic Panic Disorder: Case study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>2</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45966</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Panic disorder.</hc_freetext>
      <i_freetext>Intervention; Structured clinical interview to diagnose panic disorder; Assessing the suitability for receiving schema therapy; pre-exam; Assessment in order to conceptualize the case; Cognitive techniques; Experimental techniques; behavioural pattern-breaking techniques; Relationship therapy techniques; Execution of questionnaires during and after interventions. Interventions are performed in 17 sessions, 90 minutes per session and one session per week. Studies have shown that the results of the drug recur after a significant proportion of patients (25-50% recorded during six months) (Mahmoudi, Naderi Rajeh and Masoudzadeh, 2016). Cognitive behavioral therapy is the first line of treatment for panic disorder (Heldt et al., 2003; cited in Wesner et al., 2019). But many patients have residual symptoms or partial response to treatment (Porter &amp; Chamblless, 2015; Craske et al., 2017; quoting Wesner et al., 2019). Patients may fail during cognitive-behavioral therapy due to schema issues (Hoffart, 2017). Many patients with panic disorder are highly resistant to starting and continuing psychotherapy sessions. The reason for canceling treatment sessions, in addition to cost and disbelief in treatment, is ambiguity in treatment due to schema (Leahi, 2001, translated by Hamidpour, Anduz, and Zirak, 1396). Classical cognitive behavioral therapy has assumptions about patients that do not apply to patients with cognitive behavioral problems who have chronic, ambiguous, and pervasive problems (Young et al., 2003, translated by Hamidpour and Andouz, 2007). Research shows that focusing on schemas can be useful for patients with chronic emotional problems, including chronic anxiety (Keefe, Webb, &amp; Derubeis, 2016). Schema therapy has never been used for patients with chronic panic disorder..</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:
Share data after making it unrecognizable

When:
Start access after printing results

To whom:
Researchers in the field of mental health

Conditions:
To know the details of the study and the use of data in research studies

Where to obtain:
Baharehfarokhi@yahoo.com
, Dr. Faramarz Sohrabi Asmaroud, Fifth Floor, Faculty of Psychology and Educational Sciences, Allameh Tabatabai University

How to obtain:
Send your application by university email; It takes less than two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahareh farokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>6th Alley, MALEKOSHOARA St., SAYADSHIRAZI Blvd., JANBAZAN neighborhood, ILAM city</address>
        <city>ILAM</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931174838</zip>
        <telephone>0098842244554</telephone>
        <email>Baharehfarokhi@yahoo.com</email>
        <affiliation>Allameh Tabatabai University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahareh farokhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>6th Alley, MALEKOSHOARA St., SAYADSHIRAZI Blvd., JANBAZAN neighborhood, ILAM city</address>
        <city>ILAM</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931174838</zip>
        <telephone>0098842244554</telephone>
        <email>Baharehfarokhi@yahoo.com</email>
        <affiliation>Allameh Tabatabai University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>An initial diagnosis of Panic disorder
Psychiatric interview to diagnose Panic disorder
Chronic Panic disorder for at least a year
Age over 18 years and under 40 years
The similarity of the Drugs used by Patients
Fluency in Persian
Minimum level of education: third grade middle school</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe mental disorders, including bipolar disorder and severe depression
Drug abuse
Concurrent treatment by another psychologist
Patients who have poorly reported Successful treatment in evaluation or have no psychological mind</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Panic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention; Structured clinical interview to diagnose panic disorder; Assessing the suitability for receiving schema therapy; pre-exam; Assessment in order to conceptualize the case; Cognitive techniques; Experimental techniques; behavioural pattern-breaking techniques; Relationship therapy techniques; Execution of questionnaires during and after interventions. Interventions are performed in 17 sessions, 90 minutes per session and one session per week. Studies have shown that the results of the drug recur after a significant proportion of patients (25-50% recorded during six months) (Mahmoudi, Naderi Rajeh and Masoudzadeh, 2016). Cognitive behavioral therapy is the first line of treatment for panic disorder (Heldt et al., 2003; cited in Wesner et al., 2019). But many patients have residual symptoms or partial response to treatment (Porter &amp; Chamblless, 2015; Craske et al., 2017; quoting Wesner et al., 2019). Patients may fail during cognitive-behavioral therapy due to schema issues (Hoffart, 2017). Many patients with panic disorder are highly resistant to starting and continuing psychotherapy sessions. The reason for canceling treatment sessions, in addition to cost and disbelief in treatment, is ambiguity in treatment due to schema (Leahi, 2001, translated by Hamidpour, Anduz, and Zirak, 1396). Classical cognitive behavioral therapy has assumptions about patients that do not apply to patients with cognitive behavioral problems who have chronic, ambiguous, and pervasive problems (Young et al., 2003, translated by Hamidpour and Andouz, 2007). Research shows that focusing on schemas can be useful for patients with chronic emotional problems, including chronic anxiety (Keefe, Webb, &amp; Derubeis, 2016). Schema therapy has never been used for patients with chronic panic disorder.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Variable scores; Fear of physical worries, fear of not having cognitive control, fear of anxiety to be seen. Timepoint: Sessions 1, 5, 9, 13, 17 and one month after the last session. Method of measurement: Floyd et al. 2005 Anxiety Sensitivity Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Variable scores; General health concerns, fear of disease, fear of disease consequences. Timepoint: Sessions 1, 5, 9, 13, 17 and one month after the last session. Method of measurement: Health Anxiety Questionnaire Salkowski et al. 2002 (short form 18 questions).</sec_outcome>
      <sec_outcome>Early maladaptive schemas scores. Timepoint: Sessions 1, 5, 9, 13, 17 and one month after the last session. Method of measurement: Young Schema Questionnaire (Short Form - Third Edition - 90 Questions).</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>Allameh Tabatabai University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-01</approval_date>
        <contact_name>National Ethics Committee in Biomedical Research, Allameh Tabatabai University</contact_name>
        <contact_address>SIXTH alley, MALEKOSHOARA street, SAYAD SHIRAZI boulevard, JANBAZAN neighborhood, ILAM city Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
