<?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>IRCT20180817040818N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-23</date_registration>
      <primary_sponsor>Vice Chancellor for research of Islamic Azad university Torbat-e Jam branch</primary_sponsor>
      <public_title>The Effect of Cognitive-Behavioral Group Training of Self-Care Skills on Positive, Negative Symptoms, General psychopathology and Self-Care</public_title>
      <acronym></acronym>
      <scientific_title>The effect of cognitive-behavioral group training of self-care Skills on positive, negative symptoms, general psychopathology and self-care in patients with schizophrenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50137</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be perform by permuted block randomization. Eligible patients will be selected by the convenience method and will be divided into two groups A and B by a researcher. for this purpose, 13 blocks of four (AABB, ABAB, BABA, BBAA, ABBA, BABA, etc.) were determined and each of them was assigned a number between 1 and 13. Based on the table of random numbers, it was determined that the order of entry of blocks into the study and assignment of individuals to intervention and control groups, Blinding description: The researcher who performs the study statistics will be blind to the study conditions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They will receive cognitive behavioral group training with self-care skills content by challenging cognitive errors related to self-care skills during 10 one-and-a-half hour sessions. Intervention 2: Control group: They will receive the routine care.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The publication of the data file must be made with the permission of the Ethics committee of Islamic Azad university Torbat-e Jam branch.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoud Kashani Lotfabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Islamic Azad university Torbat-e Jam branch, 5 km of Freeman road, Torbat-e Jam</address>
        <city>Torbat-e Jam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9576174814</zip>
        <telephone>0098515282210222</telephone>
        <email>Kashanim1@mums.ac.ir</email>
        <affiliation>Islamic Azad university Torbat-e Jam branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoud Kashani Lotfabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Islamic Azad University Torbat-e Jam branch, 5 km of Freeman road, Torbat-e Jam</address>
        <city>Torbat-e Jam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9576174814</zip>
        <telephone>+985282210222</telephone>
        <email>Kashanim1@mums.ac.ir</email>
        <affiliation>Islamic Azad University Torbat-e Jam branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A minimum of six months and a maximum of three years have elapsed since the diagnosis of schizophrenia
History of at least one previous hospitalization
Achieve a score above 50 on the Positive and Negative Clinical Syndrome Scale (PANSS)
Having verbal ability, education of 8 grades or more
No change in standard antipsychotic dose in the last 3 months</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of substance and alcohol abuse
Physical  involvement with group members and therapists before initiating therapeutic interventions
Conflict with legal issues</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20-F29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia, schizotypal and delusional disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: They will receive cognitive behavioral group training with self-care skills content by challenging cognitive errors related to self-care skills during 10 one-and-a-half hour sessions.</i_keyword>
      <i_keyword>Control group: They will receive the routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Positive, negative symptoms and general psychopathology. Timepoint: Before intervention, after intervention and six months after intervention. Method of measurement: Positive and Negative Clinical Syndrome Scale (PANSS).</prim_outcome>
      <prim_outcome>Self- care. Timepoint: Before intervention, after intervention and six months after intervention. Method of measurement: Self-Care Needs Scale (SCRS-H).</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>Vice Chancellor for research of Islamic Azad university Torbat-e Jam branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-18</approval_date>
        <contact_name>Ethics committee of Islamic Azad university Torbat-e Jam branch</contact_name>
        <contact_address>Campus of Islamic Azad University of Torbat-e Jam, 5 km of Freeman road, Torbat-e-Jam Torbat-e Jam Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
