<?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>IRCT20150615022745N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Community Re-Entry Program (CRP) in Patients with Schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Community Re-Entry Program (CRP) on disability of Chronic Patients with Schizophrenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41706</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: =, Randomization description: Patients will be randomly assigned into intervention and control groups by block allocation method. The allocation sequence will be generated using the free web site www.randomization.com. To generate the allocation sequence in this system, the number of subjects per block will be set to 4. In addition, the letters A will be assigned to the intervention group and B to the control group, and eventually the allocation sequence will be generated for each block by confirming the production of the allocation sequence in this system. The cards containing the blocks will then be inserted into the standard envelope. Thus, based on the eligible patient, an envelope will be removed by the researcher by accident, and the allocation will be determined, Blinding description: The participants were Chronic Patients with Schizophrenia, who were unaware of the assignment in the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Training Community Re-Entry Program in 16 meetings: Meeting 1: Introduction to Community Re-Entry Program: A review of the return to Community Re-Entry Program of familiarity with the program.Meeting 2: Symptoms of Disabling Mental Disorders: The purpose of this meeting is to learn about what drugs are prescribed, and what benefits are obtained with the consumption of drugs.Meeting 3: determined readiness for release: The purpose of this meeting is to learn about the symptoms and behaviors that people must know to prepare for their release.Meeting 4: Planning to Community Re-Entry Program: Patients can be involved in their release schemes by learning about their accommodation and finances.Meeting 5: Communicate with community: The purpose of this meeting is to establish personal communication with the individual in society that can serve as a service source and learn more about the resources and services available in society.Meeting 6: Dealing with stress in society: The purpose of this meeting is to know that stress can play an important role in the disease, and activities that can be used to cope with stress.Meeting 7: Plan a daily schedule: The purpose of this session is to learn the benefits of having a daily schedule and then prepare it.Meeting 8: practice an appointment and do it: The purpose of this session is to learn how to arrange an appointment with the doctor after release.Meeting 9: How drugs prevent recurrence of the disease: The purpose of the meeting is to learn what the reasons for treating the medication are for the cure and the general aims of prescribing drugs and their side effects, such as overweight and how to record a daily record of drug - sleep - sleep - creating, in their calibration sheet.Meeting 10: assessing the impact of prescription drugs: The purpose of the meeting is to learn the use of their grade - ratings checklist and to use these sheets to improve communication with the physician .Meeting 11: Drug - solving problems: The meeting is meant to learn how to recognise the problems caused by medication and to know what measures they should be taking to solve their drug problems, so that the drug should have the best effect.Meeting 12: Solving the Problems  Side Effects of Drug Treatment: the meeting is meant to identify possible side effects of drugs and train people to discuss these complications .Meeting 13: identifying and determining warning symptoms for recurrence: The training session aims to teach members about the warning signs of the relapse.Meeting 14: Keeping track of warning Symptoms: The purpose of this meeting is to get people to examine their personal signaling symptoms on a daily basis, and understand that in detecting the symptoms, they need to find a person who can help them identify and examine signs of warning.Meeting 15: Emergency plan formulation: The purpose of the meeting is to teach members of the group to develop an emergency plan.Meeting 16: bring their plan into society: The purpose of the meeting is to enable people to describe their emergency plan and understand how to train all the skills they have learned in the Community Re-Entry Program. Intervention 2: Control group: In this group, there were no performed intervention, in order to compare the its results with the Experimental group.</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:
The documentation is accessible to the research team, and after completion of the study, it could only be made available to the relevant sources with permission of the research team supervisor

When:
3 months after publishing the results

To whom:
Research team's supervisor, School of Nursing and Midwifery Research Deputy

Conditions:
With the permission of the research team's supervisor

Where to obtain:
Research team's supervisor

How to obtain:
Contact with the research team's supervisor

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Taraneh Taghavi Larijani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrat Ave., Tohid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141973317</zip>
        <telephone>+98 21 6105 4311</telephone>
        <email>ttaghavi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soheil Eddin Salmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nosrat Ave., Tohid Sq</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>141973317</zip>
        <telephone>+98 21 6105 4311</telephone>
        <email>Soheil.e.salmani313@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Based on the psychiatrist's diagnosis recorded in the case
Age range 18 to 55 years
No symptoms of acute phase schizophrenia at the time of the interview
More than 5 years have passed since the illness
No symptoms of acute phase schizophrenia at the time of the interview
Don't be an active substance abuser
Do not have severe physical problems and mental retardation
The severity of the disorder is such that it is incapable of performing activities
Family members (legal guardians) satisfaction with patient participation in research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Existence Neurological diseases, orthopedic disorders, blindness  and diabetes
Diagnosis of the disorder Bipolar type I and major depression
Mental Illness Following War Injury
Psychosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Residual schizophrenia</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: Training Community Re-Entry Program in 16 meetings: Meeting 1: Introduction to Community Re-Entry Program: A review of the return to Community Re-Entry Program of familiarity with the program.Meeting 2: Symptoms of Disabling Mental Disorders: The purpose of this meeting is to learn about what drugs are prescribed, and what benefits are obtained with the consumption of drugs.Meeting 3: determined readiness for release: The purpose of this meeting is to learn about the symptoms and behaviors that people must know to prepare for their release.Meeting 4: Planning to Community Re-Entry Program: Patients can be involved in their release schemes by learning about their accommodation and finances.Meeting 5: Communicate with community: The purpose of this meeting is to establish personal communication with the individual in society that can serve as a service source and learn more about the resources and services available in society.Meeting 6: Dealing with stress in society: The purpose of this meeting is to know that stress can play an important role in the disease, and activities that can be used to cope with stress.Meeting 7: Plan a daily schedule: The purpose of this session is to learn the benefits of having a daily schedule and then prepare it.Meeting 8: practice an appointment and do it: The purpose of this session is to learn how to arrange an appointment with the doctor after release.Meeting 9: How drugs prevent recurrence of the disease: The purpose of the meeting is to learn what the reasons for treating the medication are for the cure and the general aims of prescribing drugs and their side effects, such as overweight and how to record a daily record of drug - sleep - sleep - creating, in their calibration sheet.Meeting 10: assessing the impact of prescription drugs: The purpose of the meeting is to learn the use of their grade - ratings checklist and to use these sheets to improve communication with the physician .Meeting 11: Drug - solving problems: The meeting is meant to learn how to recognise the problems caused by medication and to know what measures they should be taking to solve their drug problems, so that the drug should have the best effect.Meeting 12: Solving the Problems  Side Effects of Drug Treatment: the meeting is meant to identify possible side effects of drugs and train people to discuss these complications .Meeting 13: identifying and determining warning symptoms for recurrence: The training session aims to teach members about the warning signs of the relapse.Meeting 14: Keeping track of warning Symptoms: The purpose of this meeting is to get people to examine their personal signaling symptoms on a daily basis, and understand that in detecting the symptoms, they need to find a person who can help them identify and examine signs of warning.Meeting 15: Emergency plan formulation: The purpose of the meeting is to teach members of the group to develop an emergency plan.Meeting 16: bring their plan into society: The purpose of the meeting is to enable people to describe their emergency plan and understand how to train all the skills they have learned in the Community Re-Entry Program.</i_keyword>
      <i_keyword>Control group: In this group, there were no performed intervention, in order to compare the its results with the Experimental group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disability rate in chronic schizophrenic patients. Timepoint: Before training and one month after training. Method of measurement: WHODAS 2 36i Disability Questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-01</approval_date>
        <contact_name>Ethics committee of School of Nursing Midwifery &amp; Rehabilitation ,Tehran University of Medical Scien</contact_name>
        <contact_address>School of Nursing Midwifery ,Tehran University of Medical Sciences. Nosrat st. Tohid sq. Tehran I.IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
