<?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>IRCT20210412050937N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-14</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effectiveness of cognitive-behavioral therapy (CBT) on positive and negative psychotic symptoms and emotional regulation in patients with schizophrenia spectrum disorders</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cognitive-behavioral therapy (CBT) on positive and negative psychotic symptoms and emotional regulation in patients with schizophrenia: A single-case pilot design for five patients with schizophrenia spectrum disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>5</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60283</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia spectrum disorders.</hc_freetext>
      <i_freetext>Intervention group: Five patients with schizophrenia spectrum disorders participated in treatment sessions on a single-subject basis. The Cognitive-behavioral Therapy Manual consists of 16 sessions, each lasting 60 minutes. Two treatment sessions are performed for each patient every week. The duration of all treatment sessions was 60 days. CBT offers assessment of psychotic symptoms, Psycho-Education, working on hallucinations and delusions, self-management programs, stress vulnerability model, relaxation technique and treatment tasks..</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:
After deleting the confidential information, I will share the data file of the patients of this research with other researchers; including age, sex, occupation, education and marital status.

When:
Start of access period 3 months after the end of treatment and follow-up

To whom:
The data is only available to research colleagues and other researchers and practitioners

Conditions:
The data can be used for publication in scientific research journals. Researchers are not allowed to do any analysis and they can only view and receive the data and analyze it. Researchers are also required to make a written commitment not to publish the data file.

Where to obtain:
Send me an email: khakbaz.hamid@gmail.com 
Also refer to the following address: Hamid Khakbaz, Department of Counseling, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd., Evin, Tehran phone number: 09129484583

How to obtain:
After sending me an email and confirming the identity of the applicant, and the final confirmation of the research colleagues, the data will be sent to them. The approximate time will be 2 to 3 months

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Khakbaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, No. 362, Sheikh Akbari St., Shahr-e Rey, Tehran</address>
        <city>Shahr_e_Rey</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1841744558</zip>
        <telephone>+98 21 5591 5322</telephone>
        <email>khakbaz.hamid@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Khakbaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, No. 362, Sheikh Akbari St., Shahr-e Rey, Tehran</address>
        <city>Shahr_e_Rey</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1841744558</zip>
        <telephone>+98 21 5591 5322</telephone>
        <email>khakbaz.hamid@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>Diagnosis of schizophrenia spectrum disorders based on DSM5 criteria
Relative control of acute symptoms of patients
Average age 18 to 45 years
Voluntary attendance with informed written consent Research
Having a minimum education with a diploma certificate
Receiving a higher score on PANSS and DERS scales Compared to other patients
Patients who have been in the ward for at least one week</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No criminal or judicial problems
Alcohol or substance abuse
Neurological disorders such as epilepsy, stroke or severe concussion
High levels of disordered behavior or high risk of suicide or homicide
Diagnosis Mental retardation.
Severe learning disability</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Five patients with schizophrenia spectrum disorders participated in treatment sessions on a single-subject basis. The Cognitive-behavioral Therapy Manual consists of 16 sessions, each lasting 60 minutes. Two treatment sessions are performed for each patient every week. The duration of all treatment sessions was 60 days. CBT offers assessment of psychotic symptoms, Psycho-Education, working on hallucinations and delusions, self-management programs, stress vulnerability model, relaxation technique and treatment tasks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Positive and negative psychotic symptom score in Schizophrenia positive and negative symptom scale. Timepoint: Measures of The Positive and Negative Psychotic  Symptoms two weeks before the start of the intervention (three baseline), all intervention sessions (16 Sessions), and 3 months after the end of the intervention (three follow-up lines). Method of measurement: The Positive and Negative Psychotic Symptoms Scale.</prim_outcome>
      <prim_outcome>Emotional regulation score in the Gratz and Roemer Emotional Regulation Difficulties Scale. Timepoint: Measures of emotional regulation two weeks before the start of the intervention (three baseline), all intervention sessions (16 sessions), and 3 months after the end of the intervention (three follow-up lines). Method of measurement: Gratz and Roemer Emotional Regulation Difficulties 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>2020-02-25</approval_date>
        <contact_name>Ethics Committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>3rd floor, No. 362, Sheikh Akbari St., Shahr-e Rey, Tehran Shahr-e-Rey Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
