<?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>IRCT20230405057823N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-30</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of Narrative experiences online intervention in patients with first episode of psychosis</public_title>
      <acronym>NEON</acronym>
      <scientific_title>Investigating the effectiveness of Narrative experiences online intervention using both qualitative and quantitative methods in patients with first episode of psychosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69446</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: Making a treatment application based on the defined algorithm, Randomization description: In the present study, after selecting the subjects by targeted sampling in qualitative studies, we will then randomly assign people to two groups of experimental and control. To do this, we give the subjects number 1 to 30 and after we put them in a container, we remove two numbers each time and one in the experimental group and one in the group We put control. As such, the subjects of both groups are selected. In this study, there is no blind maker, and after the intervention, the control groups of the control group use several treatment sessions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Experimental group: receiving the intervention of online narrative experiences                                                                                                                 The Online Narrative Experiences Intervention is a large-scale research study running from 2017 to 2023 that seeks to recruit participants who are current users of any mental health service and mental health workers to design and test a clinical intervention based on recovery narratives. Made to help. The study team collects stories from a wide range of  sources, focusing on the stories of people whose voices are rarely heard by mainstream culture, and brings them together to form the world's largest online repository of mental health recovery stories. They then make these stories available to others to see, hear and read about the NEON intervention and evaluate in a randomized controlled trial whether people benefit from the neon intervention or not. They will also investigate whether access to these stories can improve the way mental health workers support people with Psychosis.                                                                   Assessments at weeks 1, 12, and 52 are required for clinical analysis. Also, follow-up assessment at 104 weeks is not required; Because at the end of the intervention, the results are subjected to qualitative analysis in addition to quantitative analysis. Intervention 2: Control group: no treatment.</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 publication program is related to the printing of the article

When:
2 years

To whom:
Only the researchers of the present study

Conditions:
Analysis and interpretation

Where to obtain:
Principal investigator

How to obtain:
Research researchers are in contact with each other

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Amini Fasakhoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gol Azin Street, Diba Alley, Golestan Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1493946761</zip>
        <telephone>+98 21 4470 2905</telephone>
        <email>amini.maryam329@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Amini Fasakhoudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Gol Azin Street, Diba Alley, Golestan Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1493946761</zip>
        <telephone>+98 21 4470 2905</telephone>
        <email>amini.maryam329@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>These patients must be in their first episode of psychosis and have not experienced or reported any history of diagnosis and treatment of schizophrenia in the past.
No history of mood disorders
No history of taking Antipsychotic drugs
No drug abuse
Failure to diagnose severe learning and mental disabilities and medical or neurological diseases that cause symptoms of psychosis.
The criteria for entering the sample with the first episode of schizophrenia are:                                                                                        meeting the conditions based on the criteria of DSM-5-TR and the duration of the diagnosis period of at least 6 months
Failure to diagnose mental disability or dementia, acute symptoms of psychosis and severe restlessness, communication and language problems that prevent interviews.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of access or support to access the Internet through a personal computer or mobile device
People experiencing crisis cannot participate in research.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>The schizophrenic disorders are characterized in general by fundamental and characteristic distortions of thinking and perception, and affects that are inappropriate or blunted. Clear consciousness and intellectual capacity are usually maintained although</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental group: receiving the intervention of online narrative experiences                                                                                                                 The Online Narrative Experiences Intervention is a large-scale research study running from 2017 to 2023 that seeks to recruit participants who are current users of any mental health service and mental health workers to design and test a clinical intervention based on recovery narratives. Made to help. The study team collects stories from a wide range of  sources, focusing on the stories of people whose voices are rarely heard by mainstream culture, and brings them together to form the world's largest online repository of mental health recovery stories. They then make these stories available to others to see, hear and read about the NEON intervention and evaluate in a randomized controlled trial whether people benefit from the neon intervention or not. They will also investigate whether access to these stories can improve the way mental health workers support people with Psychosis.                                                                   Assessments at weeks 1, 12, and 52 are required for clinical analysis. Also, follow-up assessment at 104 weeks is not required; Because at the end of the intervention, the results are subjected to qualitative analysis in addition to quantitative analysis.</i_keyword>
      <i_keyword>Control group: no treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lived experiences. Timepoint: Before the start of the intervention and the end of the intervention (qualitative part). Method of measurement: Semi-structured interview, unstructured interview and picture cards.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mental health trust scale. Timepoint: Week 1, 12 and 52 (quantitative part). Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: Week 1, 12 and 52 (quantitative part). Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Hope. Timepoint: Week 1, 12 and 52 (quantitative part). Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Psychotic attachment. Timepoint: Week 1, 12 and 52 (quantitative part). Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Personal recovery. Timepoint: Week 1, 12 and 52 (quantitative part). Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Life events. Timepoint: Week 1, 12 and 52 (quantitative part). Method of measurement: questionnaire.</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>Shahid Beheshti University of Medical Sciences-100 million toman sponsorship of product-oriented theses</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-11</approval_date>
        <contact_name>Ethics committee of shahid beheshti of Medical Sciences</contact_name>
        <contact_address>Second Floor, Building No. 2, Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Student Blvd, Shahriari Square, velenjak, Tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
