<?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>IRCT201303172266N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-15</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>Role of  need assessment based family education of schizophrenic patients on recurrence of shizophrenia, patients performance and quality of life and family members, quality of life.</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of role of "current" and "need assessment based" family education of schizophrenic patients on recurrence of shizophrenia, patients performance and quality of life and family members, quality of life.    A controlled study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1902</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Those in the control group will receive psycho-education based on the current protocols. Number of the sessions (10 sessions with 15 days intervals) and the structure were similar for the two groups (Atkinson and Coia).The subjects for education include 1) What do you know of schizophrenia?, 2) What is schizophrenia?, 3) What causes schizophrenia?, 4) Different methods of treatment for schizophrenia, 5) Problems of patient’s family, 6) Family and Schizophrenia (learning ways to deal with stress), 7) Creating an environment with minimal stress (coping skills), 8) How to manage and control the chaotic behavior of the patient, 9) Use of services and deal with crises, and 10) Where are we and where are we going?.Educators of the control group will be mental health nurses who are working for the clinic and will unaware that some of their participants are under observation by the study. Intervention 2: Those in the study group will receive psycho-education based on the current protocols. Number of the sessions (10 sessions with 15 days intervals) and the structure were similar for the two groups (Atkinson and Coia).The subjects for education include 1) What do you know of schizophrenia?, 2) What is schizophrenia?, 3) What causes schizophrenia?, 4) Different methods of treatment for schizophrenia, 5) Problems of patient’s family, 6) Family and Schizophrenia (learning ways to deal with stress), 7) Creating an environment with minimal stress (coping skills), 8) How to manage and control the chaotic behavior of the patient, 9) Use of services and deal with crises, and 10) Where are we and where are we going?. Educators of the study  group will be two residents of psychiatry educated with family education based on need assessment program.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholam Reza Kheirabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 1222 2135</telephone>
        <email>kheirabadi@bsrc.mui.ac.ir</email>
        <affiliation>Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan Universit</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Golam Reza Kheirabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>اصفهان</zip>
        <telephone>+98 31 1222 2135</telephone>
        <email>kheirabadi@bsrc.mui.ac.ir</email>
        <affiliation>Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan Universit</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criterion:  patients with schizophrenia, diagnosed based on DSM-IV-TR Criteria and their families.&#13;
Exclusion criteria: patients with debilitating diseases such as uncontrolled epilepsy and mental retardation and those who were addicted to any substance, drug, or alcohol were not included into the study. Also, those who had received psycho-education or family therapy during the past two years.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Those in the control group will receive psycho-education based on the current protocols. Number of the sessions (10 sessions with 15 days intervals) and the structure were similar for the two groups (Atkinson and Coia).The subjects for education include 1) What do you know of schizophrenia?, 2) What is schizophrenia?, 3) What causes schizophrenia?, 4) Different methods of treatment for schizophrenia, 5) Problems of patient’s family, 6) Family and Schizophrenia (learning ways to deal with stress), 7) Creating an environment with minimal stress (coping skills), 8) How to manage and control the chaotic behavior of the patient, 9) Use of services and deal with crises, and 10) Where are we and where are we going?.Educators of the control group will be mental health nurses who are working for the clinic and will unaware that some of their participants are under observation by the study.</i_keyword>
      <i_keyword>Those in the study group will receive psycho-education based on the current protocols. Number of the sessions (10 sessions with 15 days intervals) and the structure were similar for the two groups (Atkinson and Coia).The subjects for education include 1) What do you know of schizophrenia?, 2) What is schizophrenia?, 3) What causes schizophrenia?, 4) Different methods of treatment for schizophrenia, 5) Problems of patient’s family, 6) Family and Schizophrenia (learning ways to deal with stress), 7) Creating an environment with minimal stress (coping skills), 8) How to manage and control the chaotic behavior of the patient, 9) Use of services and deal with crises, and 10) Where are we and where are we going?. Educators of the study  group will be two residents of psychiatry educated with family education based on need assessment program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome of the study was improvement in symptoms severity. Timepoint: Every 3 months for 18 months. Method of measurement: Positive and Negative Syndrome Scale (PANSS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Global function of the patients. Timepoint: Baseline and then every 6 months for 18 months. Method of measurement: Global assessment of function  index(GAS0.</sec_outcome>
      <sec_outcome>Patients’ quality of life. Timepoint: Baseline and then every 6 months for 18 months. Method of measurement: Schizophrenia Quality of Life Scale.</sec_outcome>
      <sec_outcome>Quality of life of families. Timepoint: Baseline and then every 6 months for 18 months. Method of measurement: World Health Organization Quality of Life Questionnaire-Short Form.</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>Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>The study was approved by the  and all participants signed an informed consent</contact_name>
        <contact_address>Isfahan University of Medical Sciences Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
