<?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>IRCT2016081729402N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-01-08</date_registration>
      <primary_sponsor>no</primary_sponsor>
      <public_title>The effectiveness of intervention based on family psycho-education in reducing  positive and negative symptoms of patients with schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of intervention based on family psycho-education in reducing expressed emotion, quality of life, mental health, Knowledge of disease on families of patients with schizophrenia and its impact on reducing positive and negative symptoms of the disease, Adherence to Drug Therapy and Insight</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23644</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: In Group psychoeducation training, program by the researcher, in 6 sessions (twice a week) based on the third edition of the implementation of psycho-educational sessions (Mottqy Pur, 1387) with her family groups will start.Training sessions as follows: Session I: Introduction and family stories. Session two: Understanding the disease and symptoms. Session three: treatment and follow-up. Session Four: What families can do to help? Session Five: problem solving method. Session Six: specific issues and crisis prevention. Questions and discussion meetings with the early starts and then for one and a half hour session will continue on the same subject. At the end of each session, information about the meeting will be summarized in a brochure that patients be communicated to them. In each session, the assignments will be discussed. Intervention 2: Control group will receive thire Usual treatment (meeting with the psychiatrist). In order to observe professional ethics and justice, after the intervention and the implementation of the post-test than control group caregivers are invited to participate in the educational program family.</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>Samad fereidooni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatric Hospital of Professor Moharreri, Niayesh City (Bajgah), Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+7 136277503</telephone>
        <email>samadpsy@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samad fereidooni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatric Hospital of Professor Moharreri, Niayesh City (Bajgah), Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+7 136277503</telephone>
        <email>samadpsy@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences (SUMS)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients in the study entry criteria: Having schizophrenia spectrum disorders diagnostic criteria; Aged 18 to 50 years; Minimum education, Guidance and maximum license; Lack of ECT treatment for at least two months before admission and during hospitalization; At the same time you do not receive psychological therapy or 3 months before entering the study and research both; for the patient and for the family; Patient and family consent to participate in research; Living with a family member for at least three months before admission.&#13;
Exclusion criteria from the study: Acute phase or active substance abuse؛ Full criteria of borderline personality disorder ؛Having suicidal thoughts؛ History of severe medical illness؛ Mental retardation؛ mental damage؛ An absence of more than one session؛ Under the age of 18 years and above 50 years؛ Comorbidity of substance dependence disorder؛ The comorbidity of other disorders.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In Group psychoeducation training, program by the researcher, in 6 sessions (twice a week) based on the third edition of the implementation of psycho-educational sessions (Mottqy Pur, 1387) with her family groups will start.Training sessions as follows: Session I: Introduction and family stories. Session two: Understanding the disease and symptoms. Session three: treatment and follow-up. Session Four: What families can do to help? Session Five: problem solving method. Session Six: specific issues and crisis prevention. Questions and discussion meetings with the early starts and then for one and a half hour session will continue on the same subject. At the end of each session, information about the meeting will be summarized in a brochure that patients be communicated to them. In each session, the assignments will be discussed.</i_keyword>
      <i_keyword>Control group will receive thire Usual treatment (meeting with the psychiatrist). In order to observe professional ethics and justice, after the intervention and the implementation of the post-test than control group caregivers are invited to participate in the educational program family.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adherence to Drug Therapy. Timepoint: Before the intervention, after intervention. Method of measurement: Medication Adherence Rating Scale (MARS).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention, after the intervention. Method of measurement: World Health Organization Quality of Life Scale-Short Form.</prim_outcome>
      <prim_outcome>Mental health. Timepoint: Before the intervention, after the intervention. Method of measurement: General Health Questionnaire (GHQ-28).</prim_outcome>
      <prim_outcome>Expressed emotion. Timepoint: Before the intervention, after the intervention. Method of measurement: Expressed emotion questionnaire (FEQ).</prim_outcome>
      <prim_outcome>Positive and negative symptoms. Timepoint: Before the intervention, after the intervention. Method of measurement: Positive and Negative Syndrome Scale Kay, Fyzbyn and Appler (1986).</prim_outcome>
      <prim_outcome>Knowledge of disease. Timepoint: Before the intervention, after the intervention. Method of measurement: Knowledge of Schizophrenia Questionnaire (KASQ).</prim_outcome>
      <prim_outcome>Insight. Timepoint: Before the intervention, after the intervention. Method of measurement: Insight and Treatment Attitudes questionnaire (ITAQ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Relapse. Timepoint: 6 months after intervention. Method of measurement: Review patient records and reporting of 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>no</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-25</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz University of Medical Sciences (Vice President of Research) Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
