xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06042712</url>
    </required_header>
    <id_info>
      <org_study_id>IRAS 323994</org_study_id>
      <nct_id>NCT06042712</nct_id>
    </id_info>
    <brief_title>Belief-updating, Speech and Psychosis</brief_title>
    <acronym>BASIS</acronym>
    <official_title>Belief-updating and Speech: Potential Markers of Psychosis Relapse</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>King's College London</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Psychotic illnesses are characterised by hallucinations, delusions, and disturbed thoughts;&#xD;
        symptoms associated with high personal and societal costs. Despite the efficacy of&#xD;
        antipsychotic medication, approximately 84% of patients experience at least one relapse&#xD;
        within 36 months of their first episode. Thus, identifying patients who will relapse and who&#xD;
        will not, and then providing specific treatment to patients who are more likely to relapse is&#xD;
        clinically meaningful. Belief-updating and speech are promising markers to predict first&#xD;
        episode psychosis (FEP) patients future relapse outcome, as there has been evidence linking&#xD;
        these two markers with the onset and progression of psychotic symptoms.&#xD;
  &#xD;
        The present study will collect cognitive measures relating to belief-updating and speech in&#xD;
        patients with FEP at baseline, and build models to predict relapse based on these measures.&#xD;
        Belief updating tasks include simple video games (escaping from a planet in the Space Task&#xD;
        and a reversal learning task). To collect speech, participants will be asked to describe&#xD;
        ambiguous pictures. The study uses a naturalistic follow-up design; data will be collected&#xD;
        from 140 FEP patients recruited from local clinical teams and 100 healthy controls recruited&#xD;
        from advertisements. Cognitive tasks will be conducted via an online platform Gorilla using&#xD;
        participants' own device (e.g. computer, laptop, smartphone and tablet). Clinical interviews&#xD;
        can take place either online or face-to-face. Participants will attend three assessments in&#xD;
        total, at baseline and at 6-month and 12-month follow-up. Each visit will comprise two&#xD;
        components 1) cognitive tasks (45-60 minutes) and basic demographics, 2) clinical interviews.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Relapse</measure>
      <time_frame>One year</time_frame>
      <description>Change in PANNS score</description>
    </primary_outcome>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Psychosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          People with a first episode of psychosis and matched controls&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Inclusion criteria (FEP)&#xD;
  &#xD;
          Participants will be recruited from two routes:&#xD;
  &#xD;
            1. Participants who are part of Urban Mind study will be invited to the present study;&#xD;
  &#xD;
            2. Patients who are referred to the following early psychosis teams will also be invited&#xD;
               to the study: Lambeth Early Psychosis (LEO), Southwark Team for Early Psychosis&#xD;
               (STEP), Lewisham Early Intervention Service (LEIS), Croydon Outreach Assessment&#xD;
               Support Team (COAST), Central and North West London NHS Foundation Trust (NWLFT).&#xD;
  &#xD;
          Participants from both routes will need to meet the following criteria:&#xD;
  &#xD;
            -  all participants are 18 to 40 years old&#xD;
  &#xD;
            -  all participants have an adequate command of the English language to complete the&#xD;
               assessment&#xD;
  &#xD;
            -  all participants need access to laptop, smartphone or computer to complete the tasks&#xD;
  &#xD;
            -  all participants met FEP as defined by a DSM-IV diagnosis of schizophrenia,&#xD;
               schizophreniform disorder, schizoaffective disorder, or delusional disorder based on&#xD;
               the Structured Clinical Interview for DSM-IV (SCID-I) (First et al., 2002).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Exclusion criteria (FEP)&#xD;
  &#xD;
            -  Experienced more than one previous episode of psychosis&#xD;
  &#xD;
            -  Any other neurological disorders that could potentially interfere with study process&#xD;
               or patients' safety&#xD;
  &#xD;
            -  Refusing to complete the belief-updating or speech tasks&#xD;
  &#xD;
            -  Participants' answers are identified as fake answers or participants complete the&#xD;
               tasks for multiple times (identified by their unique participants code).&#xD;
  &#xD;
            -  Participants are unable to fully comprehend the purpose of the study or make a&#xD;
               rational decision whether or not to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06042712
  org study id: IRAS 323994
  nct id: NCT06042712
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Psychotic illnesses are characterised by hallucinations, delusions, and disturbed thoughts;
        symptoms associated with high personal and societal costs. Despite the efficacy of
        antipsychotic medication, approximately 84% of patients experience at least one relapse
        within 36 months of their first episode. Thus, identifying patients who will relapse and who
        will not, and then providing specific treatment to patients who are more likely to relapse is
        clinically meaningful. Belief-updating and speech are promising markers to predict first
        episode psychosis (FEP) patients future relapse outcome, as there has been evidence linking
        these two markers with the onset and progression of psychotic symptoms.
  
        The present study will collect cognitive measures relating to belief-updating and speech in
        patients with FEP at baseline, and build models to predict relapse based on these measures.
        Belief updating tasks include simple video games (escaping from a planet in the Space Task
        and a reversal learning task). To collect speech, participants will be asked to describe
        ambiguous pictures. The study uses a naturalistic follow-up design; data will be collected
        from 140 FEP patients recruited from local clinical teams and 100 healthy controls recruited
        from advertisements. Cognitive tasks will be conducted via an online platform Gorilla using
        participants' own device (e.g. computer, laptop, smartphone and tablet). Clinical interviews
        can take place either online or face-to-face. Participants will attend three assessments in
        total, at baseline and at 6-month and 12-month follow-up. Each visit will comprise two
        components 1) cognitive tasks (45-60 minutes) and basic demographics, 2) clinical interviews.
  observational model: Case-Control
  time perspective: Prospective
  measure: Relapse
  time frame: One year
  description: Change in PANNS score
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  responsible party type: Sponsor
  mesh term: Psychotic Disorders
  mesh term: Mental Disorders