<?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>IRCT20180103038207N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-04</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The Effectiveness of Community Re-entry Program (CRP) in Treatment of Schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Community Re-entry Program On Therapeutic Outcomes in Raazi Psychiatric Center Hospitalized Schizophrenic Patients, in Comparison with Conventional Psychiatric Treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28699</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: When the names of the patients who were selected in full-scale and according to the inclusion and exclusion criteria from hospitalized patients in the  non-educational acute units of Razi Educational Medical Psychiatric Hospital reached number 10, they are listed and grouped in even and odd number according to their order in list. Then the even and odd names are assigned  in the subject and control groups based on throwing the coin (tap or line), so that the first throw is done for the odd names and the tap event are assigned to experimental group and the line event in the control group. . By randomly assigning the odd persons in the list according to this method, the assignment group of even names is determined by itself and in a random fashion, Blinding description: This study is carried out in the inpatients units of the Raazi Psychiatric Center, in which the principles of double-blindedness are implemented.
In order to ensure that double-blinded principles are implemented, the implementation and scoring of research tools and all measures , the implementation of tools and conducting interviews and other evaluation and measures in the experimental and control groups are carried out by neutral evaluators, Who are unaware of the implementation of therapeutic intervention in the experimental group and the group (trial or control) in which the patients are assigned. The intervention in the experimental group will be provided by trained instructors who will be unaware of the experimental or control assignment of the participants undergoing training. Meanwhile, subjects are unaware of being present in the experimental, or in the control group.
Researcher (investigator) will score tools after implementation and interpret the findings of other measurement and evaluation methods used in this research. In order to prevent the bias in scoring tools and interpreting the results, the situation is provided so that a person is completely unaware of the logic of the present research and its evaluations, receiving the tools completed and the results of the interviews and evaluations from evaluators  along with a list of patients and their belonging to test groups and controls and Deliver them to the researcher.  The same person, after scoring tools and interpreting the results of the interviews and other evaluations performed, is responsible for communicating data with the patients in the experimental and control groups to prepare them for statistical analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia disorder (F25.2), Treatment and Rehabilitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: It consists of 40 patients who, in addition to conventional psychiatric treatment  according to hospital routines, are also subject to Community Reentry Program. The program for returning to the community consists of 16 sessions of 30 to 90 minutes as follows: By default, and based on the recommendation of the author, at least 3 sessions per week are to be held for patients and the participants should not exceed 8 persons.                                                                             Session 1: Introducing the Return to Community Program.                  Session 2: Explain the signs and symptoms of schizophrenia spectrum disorders according to the diagnosis of the participants                                                                                                Session 3: Determine the readiness of patients for discharge.                                                                                                      Session 4: Planning a Community Return Program.                           Session 5: Communicating with Society                                                Session 6: Coping with Stress in the Community.                                     Session 7: Designing a Daily Program.                                                    Session 8: Exercise Rendezvous (Visit) and Do It.                                Session 9: How do medications prevent recurrence                                Session 10: Assessing the Effect of Medications.                                Session 11: Solving Drug Problems.                                                         Session 12: Solving Drug Side Effects.                                                     Session 13: Determine the symptoms of recurrence.                               Session 14: Tracking the symptoms of recurrence.                                 Session 15: Implementing the Emergency Plan.                                        Session 16: Bring your plan to the community.                                            In each of these sessions, educational activities are conducted in a variety of ways, including viewing videos and asking questions about its content, internship and exterior classes, oral education through lecture and verbal interaction between trainer and patients, and role playing along with motivational components with Including scenarios related to the daily lives of patients will be made on their own initiative. Meanwhile, classroom assignments and the content of the sessions are recorded in a booklet by the patients and will be provided to the patients after the end of the session. Intervention 2: Control group: It consists of 40 patients who receive only routine treatment of routine psychiatric treatment and are not subject to a community reunion 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is This item will based on the policies of recruitment center and related university</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Davood Arab Ghahestany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid rastegari Blvd., Taghi abad threeway, Moallem Sq., Raazi Psychiatric Center</address>
        <city>Rey</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1866958891</zip>
        <telephone>+98 21 3341 6084</telephone>
        <email>psychosis@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Davood Arab Ghahestany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid rastegari Blvd., Taghi abad threeway, Moallem Sq., Raazi Psychiatric Center</address>
        <city>Rey</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1866958891</zip>
        <telephone>+98 21 3341 6084</telephone>
        <email>psychosis@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of schizophrenia based on medical records
Age range between 22-60 years
Having family
Tolerance for group disciplines and inclination for group activities
At least a prior hospitalization and passing two years from onset</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Comorbidity with personality substance related and addictive disorders
Having self management skills</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F25.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: It consists of 40 patients who, in addition to conventional psychiatric treatment  according to hospital routines, are also subject to Community Reentry Program. The program for returning to the community consists of 16 sessions of 30 to 90 minutes as follows: By default, and based on the recommendation of the author, at least 3 sessions per week are to be held for patients and the participants should not exceed 8 persons.                                                                             Session 1: Introducing the Return to Community Program.                  Session 2: Explain the signs and symptoms of schizophrenia spectrum disorders according to the diagnosis of the participants                                                                                                Session 3: Determine the readiness of patients for discharge.                                                                                                      Session 4: Planning a Community Return Program.                           Session 5: Communicating with Society                                                Session 6: Coping with Stress in the Community.                                     Session 7: Designing a Daily Program.                                                    Session 8: Exercise Rendezvous (Visit) and Do It.                                Session 9: How do medications prevent recurrence                                Session 10: Assessing the Effect of Medications.                                Session 11: Solving Drug Problems.                                                         Session 12: Solving Drug Side Effects.                                                     Session 13: Determine the symptoms of recurrence.                               Session 14: Tracking the symptoms of recurrence.                                 Session 15: Implementing the Emergency Plan.                                        Session 16: Bring your plan to the community.                                            In each of these sessions, educational activities are conducted in a variety of ways, including viewing videos and asking questions about its content, internship and exterior classes, oral education through lecture and verbal interaction between trainer and patients, and role playing along with motivational components with Including scenarios related to the daily lives of patients will be made on their own initiative. Meanwhile, classroom assignments and the content of the sessions are recorded in a booklet by the patients and will be provided to the patients after the end of the session.</i_keyword>
      <i_keyword>Control group: It consists of 40 patients who receive only routine treatment of routine psychiatric treatment and are not subject to a community reunion program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Awareness of the nature of disease and drug information, and readiness for discharge. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: community re entry program test.</prim_outcome>
      <prim_outcome>Ability to design a daily schedule. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: Depending on the ability to complete the daily schedule, the program returns to the community.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: Short form health questionnaire.</prim_outcome>
      <prim_outcome>Viscosity. Timepoint: During hospitalization period. Method of measurement: Based on the number of visits to the Nursing Station.</prim_outcome>
      <prim_outcome>The number of times a venous or muscular injection of psychoactive substance to calm the patient (I.e. PRN). Timepoint: At the end of intervention. Method of measurement: View patient records documentation.</prim_outcome>
      <prim_outcome>The number of fixation. Timepoint: At the end of intervention. Method of measurement: View patient records documentation.</prim_outcome>
      <prim_outcome>Positive and negative syndrome. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: Positive and negative syndrome scale.</prim_outcome>
      <prim_outcome>Inability. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: World Health Organization disability assessment schedule 2.0.</prim_outcome>
      <prim_outcome>Stigma. Timepoint: At the beginning of the study and after the end of the intervention. Method of measurement: Stigma scale Michael King.</prim_outcome>
      <prim_outcome>Duration of hospitalization. Timepoint: After inserting the discharge order in the patient file. Method of measurement: View patient records documentation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-09</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>kodakyar Ave., daneshjo Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
