<?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>IRCT20200701047974N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-02</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effectiveness of recovery-oriented cognitive therapy with and without cognitive remediation in individuals with schizophrenia disorder.</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of recovery-oriented cognitive therapy with and without cognitive remediation in individuals with schizophrenia disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49320</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In the present study, adaptive randomization methods used based on the variables of the aid of the thesis that provide decisions based on the division of individuals into two groups of interventions on a case-by-case basis. (Woman) Age (in four age groups: 30-20, 40-31, 50-41, 60-51), and severity of negative and positive symptoms (in 5 levels: (1) suspicious, (2) mild, (3) Medium, (4) obvious, (5) severe) are important variables in this study. The characteristics of the first patient in the mentioned variables are recorded. the next individuals are assigned to the groups in such a way that the difference between the groups is minimal in terms of these important variables, and thus the imbalance can be minimized, Blinding description: Those assessing outcomes and data Analyzer not being able to check the patient status and blinded to the research condition so this study will be a single-blind study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>schizophrenia disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Intervention groups A will undergo recovery oriented cognitive therapy  (CT-R). The program is designed to run individually or in groups, and will run for 14 sessions, averaging 30 minutes and 2 sessions per week. Intervention 2: Intervention group2: Intervention B groups will also be treated for 14 minutes, an average of 30 minutes, and 2 sessions per week with ecovery oriented cognitive therapy  (CT-R) with cognitive rehabilitation (CT-R + CR).</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>Alipsychologist69@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>Alipsychologist69@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>20-60 years
Diagnosis of schizophrenia based on DSM-5 criteria
At least two years have passed since the onset of schizophrenia and most of the symptoms are negative.
The score of positive and negative symptoms of the patient in SAPS tests (positive symptom assessment scale) and SANS (negative symptom evaluation scale) should be above the cutting point of 35 and 24, respectively.
Ability to reading and writing</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Brain damage, mental retardation, physical disability that interferes with the assessment process.
Neurological disease (epilepsy, Alzheimer's, dementia, Parkinson's, MS, etc.) due to which the person  being under treated
The patient is seriously affected by the side effects of psychiatric medications that interfere with the study process.
Dissatisfaction with participating in the study
The patient is in the acute phase of the disease
Receive an electroshock at least 6 months before the study and during treatment
Be currently undergoing other psychological interventions
The patient is severely affected by abuse, poisoning or deprivation of any kind of drug (smoking is not considered a exclusion criterion ).</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>Intervention group1: Intervention groups A will undergo recovery oriented cognitive therapy  (CT-R). The program is designed to run individually or in groups, and will run for 14 sessions, averaging 30 minutes and 2 sessions per week.</i_keyword>
      <i_keyword>Intervention group2: Intervention B groups will also be treated for 14 minutes, an average of 30 minutes, and 2 sessions per week with ecovery oriented cognitive therapy  (CT-R) with cognitive rehabilitation (CT-R + CR).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Negative Symptoms. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Scale for Assessment of Negative Symptoms (SANS).</prim_outcome>
      <prim_outcome>Positive Symptoms. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Scale for Assessment of Positive Symptoms (SAPS).</prim_outcome>
      <prim_outcome>Neurocognitive impairment. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: MATRICES.</prim_outcome>
      <prim_outcome>Dysfunctional Attitude. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Dysfunctional Attitude Scale (DAS).</prim_outcome>
      <prim_outcome>Real-World Functioning. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: WHO DAS .2.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Self-report quality of life measure for people with schizophrenia.</prim_outcome>
      <prim_outcome>Mental Health Recovery. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Mental Health Recovery Measure.</prim_outcome>
      <prim_outcome>Recovery. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: Recovery Self-Assessment–Revised (RSA-R).</prim_outcome>
      <prim_outcome>Hope. Timepoint: Per-intervention, mid intervention and post-intervention and follow up. Method of measurement: The Schizophrenia Hope Scale.</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>2020-06-22</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>kodakyar Ave., daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
