<?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>IRCT20180928041165N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-03</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effect of systematic education on the process of receiving mental health care services</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of systematic patient and family education in the psychiatric emergency room on the process of receiving mental health care services</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34209</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Randomization Method: Simple
Randomization Unit: Individual
Randomization Tool: Envelope Shuffling
Concealment: Simple, Blinding description: Patients in the test and control groups are unaware of which group they are in, but they are aware of the existence of different study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Schizophrenia. Condition 2: Major depressive disorder. Condition 3: Conversion disorder. Condition 4: Panic disorder. Condition 5: Bipolar disorder. Condition 6: Alcohol related disorders. Condition 7: Opioid related disorders. Condition 8: Cannabis related disorders. Condition 9: Sedative related disorders. Condition 10: Cocaine related disorders. Condition 11: Other stimulant related disorders. Condition 12: Hallucinogen related disorders. Condition 13: Nicotine dependence. Condition 14: Inhalant related disorders. Condition 15: Other psychoactive substance related disorders.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, one session of "psycho-education" with predefined content will be provided. The content of this session includes: the name of the disease/disorder, symptoms, signs, etiology, possible treatments and the prognosis. This 15-minute , interactional session will be provided by psychiatry residents of Department of Psychiatry, Tabriz University of Medical Sciences. Intervention 2: Control group: This group will receive the routine care and routine educational materials within the emergency room.</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:
In this study, only data on changes in symptoms and the frequency of referral to an emergency room or clinic, the frequency of referral to treating doctor, referral to other professionals, medications and their use will be provided.

When:
one year after publication.

To whom:
Researchers working in academic and Scientific institutions

Conditions:
research in the field of mental health services

Where to obtain:
1-Library of Tabriz University of Medical Sciences
2- Library of Razi Hospital in Tabriz
3- Contact the mahsaraji90@gmail.com email address

How to obtain:
Contact with the corresponding author via email, and answer will be provided within 72 hours

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrdad Ghaemmaghami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Hospital,Sheykh Mohammad Khiyabani Ave, Elgoli,Tabriz Town</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5167846184</zip>
        <telephone>+98 41 3380 4486</telephone>
        <email>Mehrdad.ghaem25@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrdad Ghaemmaghami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Hospital,Sheykh Mohammad Khiyabani Ave, Elgoli,Tabriz Town</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5167846184</zip>
        <telephone>+98 41 3380 4486</telephone>
        <email>Mehrdad.ghaem25@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability and willingness to informed consent</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of family members
Impaired consciousnesses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
      <hc_code>F32</hc_code>
      <hc_code>F44</hc_code>
      <hc_code>F41.0</hc_code>
      <hc_code>F31</hc_code>
      <hc_code>F10</hc_code>
      <hc_code>F11</hc_code>
      <hc_code>F12</hc_code>
      <hc_code>F13</hc_code>
      <hc_code>F14</hc_code>
      <hc_code>F15</hc_code>
      <hc_code>F16</hc_code>
      <hc_code>F17</hc_code>
      <hc_code>F18</hc_code>
      <hc_code>F19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
      <hc_keyword>Dissociative and conversion disorders</hc_keyword>
      <hc_keyword>Panic disorder [episodic paroxysmal anxiety] without agoraphobia</hc_keyword>
      <hc_keyword>Bipolar disorder</hc_keyword>
      <hc_keyword>Alcohol related disorders</hc_keyword>
      <hc_keyword>Opioid related disorders</hc_keyword>
      <hc_keyword>Cannabis related disorders</hc_keyword>
      <hc_keyword>Sedative, hypnotic, or anxiolytic related disorders</hc_keyword>
      <hc_keyword>Cocaine related disorders</hc_keyword>
      <hc_keyword>Other stimulant related disorders</hc_keyword>
      <hc_keyword>Hallucinogen related disorders</hc_keyword>
      <hc_keyword>Nicotine dependence</hc_keyword>
      <hc_keyword>Inhalant related disorders</hc_keyword>
      <hc_keyword>Other psychoactive substance related disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, one session of "psycho-education" with predefined content will be provided. The content of this session includes: the name of the disease/disorder, symptoms, signs, etiology, possible treatments and the prognosis. This 15-minute , interactional session will be provided by psychiatry residents of Department of Psychiatry, Tabriz University of Medical Sciences.</i_keyword>
      <i_keyword>Control group: This group will receive the routine care and routine educational materials within the emergency room.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency of visits to the emergency room or clinic, frequency of visits to treating doctor, the referral to other specialists, medications and their use it, symptoms. Timepoint: Study of the variables before intervention and 4 weeks after the end of the intervention. Method of measurement: The questionnaire designed by the researcher.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change of symptoms. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Questionnaire designed by researcher and description of the patient's family.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-23</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Razi Hospital,Sheykh Mohammad Khiyabani Ave, Elgoli,Tabriz Town Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
