<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/NCT02192593</url>
  </required_header>
  <id_info>
    <org_study_id>ComputerCBTPsychosis</org_study_id>
    <nct_id>NCT02192593</nct_id>
  </id_info>
  <brief_title>Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations</brief_title>
  <official_title>Randomized Controlled Trial of Computerized Cognitive Behavioral Therapy for Auditory Hallucinations in Persons With Psychosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University Charles River Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University Charles River Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial, examining the effects of a computerized,&#xD;
      internet-based Cognitive Behavioral Therapy (CBT) Intervention for persons with a&#xD;
      schizophrenia spectrum disorder who experience distressing auditory hallucinations (voices).&#xD;
      Participants are randomized to one of two conditions: either to receive the 10-session&#xD;
      computer-based program on a weekly basis, or to their usual care at their mental health&#xD;
      clinic. This study takes place at Cambridge Health Alliance in Cambridge Massachusetts. It is&#xD;
      hypothesized that the participants who participate in the CBT program will have significant&#xD;
      improvements in the severity of their auditory hallucinations, as well as their associated&#xD;
      distress, compared to the participants receiving usual care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Psychiatric Rating Scale (BPRS)</measure>
    <time_frame>Baseline, Post-Treatment, 3-Month Follow-up</time_frame>
    <description>Primary outcome is change in BPRS hallucinations item from baseline to post-treatment to 3 month follow-up. This measure assesses severity of auditory hallucinations as well as overall psychiatric symptoms</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Schizophrenia, Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>Computer CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 10-session computerized cognitive-behavioral therapy intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer CBT</intervention_name>
    <arm_group_label>Computer CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be on a stable dose of antipsychotic medication for the past 3&#xD;
             months.&#xD;
&#xD;
               -  Schizophrenia-spectrum diagnosis, including schizophrenia, schizoaffective&#xD;
                  disorder, schizophreniform disorder, and psychosis, not otherwise specified.&#xD;
&#xD;
               -  At least moderate severity on Brief Psychiatric Rating Scale (BPRS)&#xD;
                  hallucinations item.&#xD;
&#xD;
               -  Naïve to CBTp for Auditory Hallucinations within the past 3 years.&#xD;
&#xD;
               -  No current suicidal ideation or hospitalization within the past month.&#xD;
&#xD;
               -  Reading level of at least 4th grade, as measured by the reading section of the&#xD;
                  Wide Range Achievement Test (WRAT)&#xD;
&#xD;
               -  Current patient receiving care at Cambridge Health Alliance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Terminal physical illness expected to result in the death of the study participant&#xD;
             within one year.&#xD;
&#xD;
               -  Primary diagnosis of dementia or a diagnosis of a psychiatric disorder secondary&#xD;
                  to a medical condition.&#xD;
&#xD;
               -  Comorbid dementia (severe cognitive impairment) as indicated by a Mini-mental&#xD;
                  state examination score &lt;24.&#xD;
&#xD;
               -  Current active substance abuse or dependence with the need for specialized&#xD;
                  substance abuse services&#xD;
&#xD;
               -  Does not speak English&#xD;
&#xD;
               -  Does not achieve a 4th grade reading level as demonstrated on the Wide Range&#xD;
                  Achievement Test (WRAT)&#xD;
&#xD;
               -  Has a legal guardian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer D Gottlieb, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cambridge Health Alliance</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 13, 2013</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>March 3, 2017</last_update_submitted>
  <last_update_submitted_qc>March 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston University</investigator_affiliation>
    <investigator_full_name>Jennifer Gottlieb</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallucinations</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic 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/NCT02192593
org study id: ComputerCBTPsychosis
nct id: NCT02192593
lead sponsor: 
has dmc: No
This is a randomized controlled trial, examining the effects of a computerized,
      internet-based Cognitive Behavioral Therapy (CBT) Intervention for persons with a
      schizophrenia spectrum disorder who experience distressing auditory hallucinations (voices).
      Participants are randomized to one of two conditions: either to receive the 10-session
      computer-based program on a weekly basis, or to their usual care at their mental health
      clinic. This study takes place at Cambridge Health Alliance in Cambridge Massachusetts. It is
      hypothesized that the participants who participate in the CBT program will have significant
      improvements in the severity of their auditory hallucinations, as well as their associated
      distress, compared to the participants receiving usual care.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Brief Psychiatric Rating Scale (BPRS)
time frame: Baseline, Post-Treatment, 3-Month Follow-up
description: Primary outcome is change in BPRS hallucinations item from baseline to post-treatment to 3 month follow-up. This measure assesses severity of auditory hallucinations as well as overall psychiatric symptoms
arm group label: Computer CBT
arm group type: Experimental
description: A 10-session computerized cognitive-behavioral therapy intervention
arm group label: Usual Care
arm group type: No Intervention
intervention type: Behavioral
intervention name: Computer CBT
arm group label: Computer CBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jennifer D Gottlieb, PhD
role: Principal Investigator
affiliation: Boston University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston University
investigator full name: Jennifer Gottlieb
investigator title: Research Assistant Professor
mesh term: Hallucinations
mesh term: Schizophrenia
mesh term: Psychotic Disorders