<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/NCT01704833</url>
  </required_header>
  <id_info>
    <org_study_id>0505007908</org_study_id>
    <nct_id>NCT01704833</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy for Paranoia in Schizophrenia</brief_title>
  <acronym>CBTp</acronym>
  <official_title>Cognitive Behavioral Therapy for Paranoia in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Alliance for Research on Schizophrenia and Depression</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to determine the preliminary efficacy of Paranoia-Focused&#xD;
      Cognitive Behavioral Therapy (PFCBT) relative to standard care in the treatment of&#xD;
      persecutory delusions in patients diagnosed with schizophrenia or schizoaffective Disorder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) is a manualized intervention that&#xD;
      combines group and individual modalities to reduce paranoia-biased information-processing and&#xD;
      social avoidance, and to increase insight and reality testing capacity.&#xD;
&#xD;
      This is a randomized controlled clinical trial. Twenty four adults ages 18-65 with the&#xD;
      primary DSM-IV Schizophrenia and Schizoaffective disorder and drug-refractory persecutory&#xD;
      delusions will be recruited from outpatient clinics in New York City Metropolitan area.&#xD;
      Participants will be randomly assigned to either experimental or control group. The&#xD;
      experimental group will receive PFCBT in addition to standard care and the control group will&#xD;
      receive standard care alone. PFCBT will include participation in one group session and one&#xD;
      individual therapy session weekly over the 15 weeks. The preliminary efficacy of the&#xD;
      intervention will be evaluated using standardized measures by blind evaluators conducted at&#xD;
      baseline, post-treatment, and at 6-months post-termination follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2006</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">September 2009</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Persecution Severity at week 16 and at week 42.</measure>
    <time_frame>Measured at baseline, at week 16, and at week 42.</time_frame>
    <description>Measured by the Persecution sub-scale on Positive and Negative Syndrome Scale (PANSS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Attributional Style at week 16.</measure>
    <time_frame>Measured at baseline and at week 16.</time_frame>
    <description>Internal Personal and Situational Attributions Questionnaire.Measures attributional style (a tendency to attribute cause for negative events to situational or personal causes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in a Tendency to Jump to Conclusions at week 16.</measure>
    <time_frame>Measured at baseline and at week 16.</time_frame>
    <description>Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Cognitive Insight at week 16.</measure>
    <time_frame>Measured at baseline and at week 16.</time_frame>
    <description>Beck Cognitive Insight Scale. Measures cognitive insight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Dimensions of Paranoid Delusions</measure>
    <time_frame>Measured at baseline, at week 16 and at week 42.</time_frame>
    <description>Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The Working Alliance Inventory (WAI)</measure>
    <time_frame>Measured at week 16 (post CBT).</time_frame>
    <description>Used to assess the participants' perceived alliance to the therapist.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Empathy Scale (ES)</measure>
    <time_frame>Measured at week 16 (post CBT).</time_frame>
    <description>Measures participants' perceptions of the therapist's warmth, genuineness, and empathy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Group Cohesiveness Scale (GCS)</measure>
    <time_frame>Measured at week 16 (post CBT).</time_frame>
    <description>Measures group cohesiveness.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes from Baseline in Brain Circuitry at week 42.</measure>
    <time_frame>Measured at baseline and at week 42.</time_frame>
    <description>'Linguistic threat' fMRI paradigm is used to monitor brain circuitry changes associated with PFCBT.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Paranoid Delusions</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group receives standard care only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)</intervention_name>
    <description>The PFCBT is a 15-week Program that includes weekly group and individual sessions.</description>
    <arm_group_label>Cognitive Behavioral Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 65 years&#xD;
&#xD;
          -  Met DSM IV diagnostic criteria for schizophrenia or schizoaffective disorder,&#xD;
             confirmed by the Clinical Structural Diagnostic Interview (SCID, First et al, 1997)&#xD;
             -Reported persistent and distressing paranoid delusion(s);&#xD;
&#xD;
          -  A minimum severity score of 4 point Persecution subscale on The Positive and Negative&#xD;
             Syndrome Scale (PANSS)&#xD;
&#xD;
          -  Had an adequate trial (6 months or more) and were stabilized on antipsychotic&#xD;
             medications (no change in psychiatric medication prescribed in the last month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Substance misuse or medical disorder identified as the primary cause of delusions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yulia Landa, Psy D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psychosis</keyword>
  <keyword>Paranoia</keyword>
  <keyword>Cognitive Behavioral Therapy</keyword>
  <keyword>Delusions</keyword>
  <keyword>Group Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Delusions</mesh_term>
    <mesh_term>Paranoid Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01704833
org study id: 0505007908
nct id: NCT01704833
lead sponsor: 
collaborator: 
has dmc: No
The main objective of this study is to determine the preliminary efficacy of Paranoia-Focused
      Cognitive Behavioral Therapy (PFCBT) relative to standard care in the treatment of
      persecutory delusions in patients diagnosed with schizophrenia or schizoaffective Disorder.
Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) is a manualized intervention that
      combines group and individual modalities to reduce paranoia-biased information-processing and
      social avoidance, and to increase insight and reality testing capacity.

      This is a randomized controlled clinical trial. Twenty four adults ages 18-65 with the
      primary DSM-IV Schizophrenia and Schizoaffective disorder and drug-refractory persecutory
      delusions will be recruited from outpatient clinics in New York City Metropolitan area.
      Participants will be randomly assigned to either experimental or control group. The
      experimental group will receive PFCBT in addition to standard care and the control group will
      receive standard care alone. PFCBT will include participation in one group session and one
      individual therapy session weekly over the 15 weeks. The preliminary efficacy of the
      intervention will be evaluated using standardized measures by blind evaluators conducted at
      baseline, post-treatment, and at 6-months post-termination follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline in Persecution Severity at week 16 and at week 42.
time frame: Measured at baseline, at week 16, and at week 42.
description: Measured by the Persecution sub-scale on Positive and Negative Syndrome Scale (PANSS).
measure: Change from Baseline in Attributional Style at week 16.
time frame: Measured at baseline and at week 16.
description: Internal Personal and Situational Attributions Questionnaire.Measures attributional style (a tendency to attribute cause for negative events to situational or personal causes).
measure: Change from Baseline in a Tendency to Jump to Conclusions at week 16.
time frame: Measured at baseline and at week 16.
description: Measured by the BEADS Task. Measures a tendency to jump to conclusions when making a judgment.
measure: Change from Baseline in Cognitive Insight at week 16.
time frame: Measured at baseline and at week 16.
description: Beck Cognitive Insight Scale. Measures cognitive insight.
measure: Change from Baseline in Dimensions of Paranoid Delusions
time frame: Measured at baseline, at week 16 and at week 42.
description: Psychotic Symptom Rating Scales (PSYRATS), Delusions. Measure dimensions of delusions.
measure: The Working Alliance Inventory (WAI)
time frame: Measured at week 16 (post CBT).
description: Used to assess the participants' perceived alliance to the therapist.
measure: The Empathy Scale (ES)
time frame: Measured at week 16 (post CBT).
description: Measures participants' perceptions of the therapist's warmth, genuineness, and empathy.
measure: Group Cohesiveness Scale (GCS)
time frame: Measured at week 16 (post CBT).
description: Measures group cohesiveness.
measure: Changes from Baseline in Brain Circuitry at week 42.
time frame: Measured at baseline and at week 42.
description: 'Linguistic threat' fMRI paradigm is used to monitor brain circuitry changes associated with PFCBT.
arm group label: Cognitive Behavioral Therapy
arm group type: Experimental
description: This group receives 15 weeks of Paranoia-Focused Cognitive Behavioral Therapy (PFCBT) in addition to standard care.
arm group label: Treatment as Usual
arm group type: No Intervention
description: This group receives standard care only.
intervention type: Behavioral
intervention name: Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)
description: The PFCBT is a 15-week Program that includes weekly group and individual sessions.
arm group label: Cognitive Behavioral Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yulia Landa, Psy D.
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Delusions
mesh term: Paranoid Disorders