<?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>IRCT20230617058502N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-07</date_registration>
      <primary_sponsor>Islamic Azad University of Shiraz</primary_sponsor>
      <public_title>Attention rehabilitation for anxious patients</public_title>
      <acronym></acronym>
      <scientific_title>Attention rehabilitation for anxious patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71941</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the random allocation of the participants to the intervention and control groups, which were named A and B respectively, 30 numbers from the random number table were selected by computer. First, numbers 1 to 30 were given to each participant and then using the simple random sampling method, 15 people were randomly selected and placed in the intervention group. The remaining 15 people also entered the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety Disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive attention rehabilitation for the intervention group was conducted in six sessions. The first session included pre-test and introduction of attention and levels of attention as input in the information processing model and explained the impairment and involvement of attention in anxious patients. In the second session, intervention training at the first level of attention and selective attention was explained to the patients and exercises were performed in this area. The third session included intervention training at the level of attention maintenance and exercises in this area. The fourth session included intervention training in divided attention and exercises in this area. The fifth session included re-explaining the levels of attention and integrating the techniques and performing the exercise. In the sixth session, exercises were performed in the field of attention and also included completing the post-test. Between sessions, exercises were also given to be done at home, which were checked at the beginning of the next session. At the beginning of all sessions, a form was given to the patient and asked to rate their anxious thoughts and anxiety level from 0 to 100, and at the end of the sessions, patients were asked to rate their anxiety level again from 0 to 100. Intervention 2: Control group: no psychological intervention: Subjects in this group did not receive psychological interventions individually or in groups.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yalda Nasihatkon</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farzanegan residential complex, Shahid Rahmati street، Rajaei Blvd ( Farhang Shahr blvd)</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184856154</zip>
        <telephone>+98 71 3638 8294</telephone>
        <email>nasihatkonyalda@gmail.com</email>
        <affiliation>Islamic Azad University of Shiraz</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Leila Khabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad university Shiraz Branch 5th Km Of Sadra Highway</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>-</telephone>
        <email>l.khabir@shirazu.ac.ir</email>
        <affiliation>Islamic Azad University of Shiraz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>having received diagnosis of anxiety disorders by a psychologist or psychiatrist
average score of 16-25 on Beck Anxiety Inventory
minimum educational qualification is a diploma
over 18 years of age
If one has received psychiatric intervention, at least 4 months must have passed, meaning that the medication has exerted its therapeutic effect and we have controlled its effectiveness. In the pre-test, we are in the maintenance stage of drug treatment.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from an acute psychiatric disorder or other disorders such as schizophrenia spectrum
Suffering from severe physical illnesses requiring hospitalization
Dependence and addiction to drugs, medicine or alcohol
Suffering from mental retardation.</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cognitive attention rehabilitation for the intervention group was conducted in six sessions. The first session included pre-test and introduction of attention and levels of attention as input in the information processing model and explained the impairment and involvement of attention in anxious patients. In the second session, intervention training at the first level of attention and selective attention was explained to the patients and exercises were performed in this area. The third session included intervention training at the level of attention maintenance and exercises in this area. The fourth session included intervention training in divided attention and exercises in this area. The fifth session included re-explaining the levels of attention and integrating the techniques and performing the exercise. In the sixth session, exercises were performed in the field of attention and also included completing the post-test. Between sessions, exercises were also given to be done at home, which were checked at the beginning of the next session. At the beginning of all sessions, a form was given to the patient and asked to rate their anxious thoughts and anxiety level from 0 to 100, and at the end of the sessions, patients were asked to rate their anxiety level again from 0 to 100.</i_keyword>
      <i_keyword>Control group: no psychological intervention: Subjects in this group did not receive psychological interventions individually or in groups.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score in Beck Anxiety Inventory. Timepoint: Assessing the anxiety level of the participants before, immediately and one month after the intervention. Method of measurement: Beck Anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Executive functions score in Wisconsin Card Sorting Test. Timepoint: before, immediately and one month after the intervention. Method of measurement: Wisconsin Card Sorting Test (WCST).</sec_outcome>
      <sec_outcome>Memory score in Digit Span. Timepoint: before, immediately and one month after the intervention. Method of measurement: Digit Span (DGS) measure in WISC.</sec_outcome>
      <sec_outcome>Attention score in The Stroop Color and Word Test. Timepoint: before, immediately and one month after the intervention. Method of measurement: The Stroop Color and Word Test.</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 of Shiraz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-19</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University- Shiraz Branch</contact_name>
        <contact_address>South Qa'ani street, 14th Alley, Faculty of Dentistry Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
