<?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>IRCT20150427021965N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-26</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Psycho educational Therapy and Positive and Negative Symptoms of patients with Chronic Schizophrenia Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Trial of the Effectiveness of Psycho educational Therapy on the Positive and Negative Symptoms of people with Chronic Schizophrenia Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40583</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Blinding will not be done in this study. Patients and therapists are aware of the study. After sampling by available method, the specimens were randomly divided into two groups of case and control. Given that the total number of samples is 24, 12 blocks are provided by expert statistician. Blocking will be used to create the number of samples assigned to each treatment group, Randomization description: Patients are randomly divided into two groups with psychiatric intervention based on psychological training and control group. Given that the total number of samples is 24, 6 blocks of 4 are provided by a statistic expert. Then the assistant allocates patients into each group through closed envelopes. The intervention group will be under the common treatment (medical treatment) along with psychotherapy based on psychological training, and the control group will only be treated as commonly.</study_design>
      <phase>3</phase>
      <hc_freetext>Schizophrenia Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group will be treated as common with psychotherapy based on psychological training. The training will be run by a psychiatrist assistant who is familiar with psychological training techniques, within 6 weeks of each week, 1 session, 1-5 hours per hour. Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention, with BDI depression tests, BAI anxiety, SF-36 quality of life, and positive and negative PANSS symptoms. The intervention will take place in a group. In this research, an interventional program for psychological training will be used based on study (20) and will be organized in 6 sessions of 1-5 / 1 hour and weekly. The following is provided below for the implementation of the training sessions: Session 1: Explain the nature of the schizophrenia and its symptoms. Second session: Explaining the cause of schizophrenia and the importance of family role in emotional support of patients. Session 3: An explanation of the drug treatment and the importance of continuing it in the recovery process. Session Four: Identifying starters and the risk of recurrence. Session 5: Problem-Solving Interventions in Patients. Session Six: Identify Stressful and Emerging Factors and Train Stress Management Techniques. Intervention 2: Control group: Individuals in the routine drug therapy group (Olanzapine will receive 20 to 25 mg twice daily, or Risperidone 6 mg daily twice daily).</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:
All data will be coded and unidentifiable, will be shared.

When:
Start the access period 3-6 months after printing the results

To whom:
All physicians and paramedics in the field of psychology

Conditions:
For more information on rehabilitation methods for patients with psychiatric disorders

Where to obtain:
Postal address: Shafa Hospital, 15 Khordad Street, Rasht, Iran - Email address: Kavosh1400@gmail.com

How to obtain:
The demandant will be responded to by the moderator after 3-5 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aida Yahyazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 khordad avenue, Shafa Hospital</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55599</zip>
        <telephone>+98 13 3366 6268</telephone>
        <email>aidayahyazadeh@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Homa Zarrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 khordad avenue, Shafa Hospital.</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41939-55599</zip>
        <telephone>+98 13 3366 6268</telephone>
        <email>kavosh1400@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients referred to the clinic of the Shafa Hospital who has a diagnosis of chronic schizophrenia based on DSM-5 criteria and in controlled conditions.
Members must have at least elementary education.
Patients aged 18-35 years old
Have the desire to enter the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having other psychiatric disorders
Having physically debilitating disease</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group will be treated as common with psychotherapy based on psychological training. The training will be run by a psychiatrist assistant who is familiar with psychological training techniques, within 6 weeks of each week, 1 session, 1-5 hours per hour. Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention, with BDI depression tests, BAI anxiety, SF-36 quality of life, and positive and negative PANSS symptoms. The intervention will take place in a group. In this research, an interventional program for psychological training will be used based on study (20) and will be organized in 6 sessions of 1-5 / 1 hour and weekly. The following is provided below for the implementation of the training sessions: Session 1: Explain the nature of the schizophrenia and its symptoms. Second session: Explaining the cause of schizophrenia and the importance of family role in emotional support of patients. Session 3: An explanation of the drug treatment and the importance of continuing it in the recovery process. Session Four: Identifying starters and the risk of recurrence. Session 5: Problem-Solving Interventions in Patients. Session Six: Identify Stressful and Emerging Factors and Train Stress Management Techniques.</i_keyword>
      <i_keyword>Control group: Individuals in the routine drug therapy group (Olanzapine will receive 20 to 25 mg twice daily, or Risperidone 6 mg daily twice daily).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Positive symptoms of schizophrenia disorder. Timepoint: Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention. Method of measurement: Patients will be evaluated by Positive and Negative Syndrome Scale (PNSS).</prim_outcome>
      <prim_outcome>Negative symptoms of schizophrenia disorder. Timepoint: Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention. Method of measurement: Patients will be evaluated by Positive and Negative Syndrome Scale (PNSS).</prim_outcome>
      <prim_outcome>Depression symptoms. Timepoint: Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention. Method of measurement: Patients will be evaluated by Beck Depression Scale.</prim_outcome>
      <prim_outcome>Symptoms of Anxiety. Timepoint: Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention. Method of measurement: Patients will be evaluated by Beck Anxiety Scale.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention. Method of measurement: Patients will be evaluated by SF36.</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>Research assistance University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-26</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Old Building of School of Health, In front of the 17th Shahrivar Hospital, Shahid Siadati Avenue, Namjoo St. Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
