<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/NCT02974400</url>
  </required_header>
  <id_info>
    <org_study_id>159384</org_study_id>
    <nct_id>NCT02974400</nct_id>
  </id_info>
  <brief_title>Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for People With Psychosis</brief_title>
  <acronym>EviBaS</acronym>
  <official_title>Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for Persecutory Ideation and Auditory Verbal Hallucinations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Schizophrenia is a severe mental disorder which is accompanied by an enormous individual and&#xD;
      societal burden. Despite established efficacy of cognitive behavioral therapy for psychosis&#xD;
      (CBTp), its dissemination into routine mental health care remains poor. National regulations&#xD;
      such as the National Institute for Health and Care Excellence (NICE) guideline in the United&#xD;
      Kingdom recommend that CBTp should be offered to every person with psychotic symptoms, but&#xD;
      more than 50% do not receive even a single session of CBTp. In Germany, CBTp is virtually not&#xD;
      represented in the psychotherapy health service. Internet-based cognitive behavioral therapy&#xD;
      (CBT) in a self-help format has been proven feasible and effective in anxiety and depressive&#xD;
      disorders. Recently, Internet-based (self-help) interventions are also deployed via&#xD;
      smartphone apps. The feasibility of Internet-based treatments for people with schizophrenia&#xD;
      is well documented for Internet-based interventions (e.g., medication management) and also&#xD;
      reported for smartphone interventions. However, there is a dearth of empirical studies&#xD;
      precluding a conclusive picture. As far as the investigators know, there is only one study&#xD;
      encompassing 90 participants with psychosis that investigated an Internet-based intervention&#xD;
      with symptom-specific, cognitive behavioral interventions, which is from the investigators'&#xD;
      research group. The unique features of the proposed project are 1) the first-time evaluation&#xD;
      of a symptom-oriented, CBTp-based self-help treatment for people with psychotic symptoms via&#xD;
      Internet, enhanced with smartphone assistance. The study is set up as randomized controlled&#xD;
      trial (RCT) with active treatment versus a wait-list control group. It evaluates a combined&#xD;
      Internet-based guided self-help treatment for persecutory ideation and auditory verbal&#xD;
      hallucinations. The active treatment condition consists of access to a self-help website&#xD;
      including regular written electronic contact with a guide and access to smartphone-based&#xD;
      interactive worksheets (apps). The trials combine the low-threshold advantages of an online&#xD;
      approach (e.g., anonymity) with the virtues of a clinical trial (e.g., symptom assessment and&#xD;
      diagnostic verification via Interview). The primary outcome measure is the Positive and&#xD;
      Negative Syndrome Scale (PANSS). Secondary outcome measures include self-reported symptom&#xD;
      measures (Paranoia Checklist; Beliefs About Voices Questionnaire revised), completion rates,&#xD;
      drop-out from the intervention, general symptomatology, side-effects, and client&#xD;
      satisfaction. The project will help to answer the empirical question whether CBTp-based&#xD;
      interventions in a purely Internet-based self-help format are effective. Positive findings&#xD;
      would pave the way for an easy-to-access treatment option for patients with psychotic&#xD;
      symptoms who currently are deprived of psychotherapeutic treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Actual">April 16, 2019</completion_date>
  <primary_completion_date type="Actual">April 16, 2019</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>Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>Change in PANSS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)</time_frame>
    <description>Kay et al. (1987); clinician administered</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Paranoia Checklist (PC)</measure>
    <time_frame>Change in PC from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)</time_frame>
    <description>Freeman et al. (2005); self-report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Launay-Slade Hallucination Scale (LSHS)</measure>
    <time_frame>Change in LSHS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)</time_frame>
    <description>Bentall &amp; Slade (1985); self-report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Change in PHQ-9 from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)</time_frame>
    <description>Spitzer, Kroenke &amp; Williams, 1999; self-report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incongruence Scale (INK)</measure>
    <time_frame>Change in INK from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)</time_frame>
    <description>Grosse Holtforth, Grawe &amp; Tamcan (2004); self-report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (WHO-QOL)</measure>
    <time_frame>Change in WHO-QOL from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)</time_frame>
    <description>WHO; self-report</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Hallucinations</condition>
  <condition>Persecutory Delusion</condition>
  <arm_group>
    <arm_group_label>Internet-based guided self-help</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Internet-based, guided, CBT-oriented self-help treatment for persecutory ideation and auditory verbal hallucinations with access to a self-help website including regular written electronic contact with a guide and access to smartphone-based interactive worksheets (8 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-List</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait-list control group (8 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-based, CBT-oriented, guided self-help</intervention_name>
    <description>The self-help program includes sessions regarding (1) cognitive model, (2) sleep hygiene, (3) mindfulness, (4) meta-cognition, (5) coping with voice hearing, (6) persecutory ideation, (7) worrying, (8) self-esteem, (9) depression, (10) social competence, and (11) relapse prevention.</description>
    <arm_group_label>Internet-based guided self-help</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Electronic informed consent&#xD;
&#xD;
          -  Internet access&#xD;
&#xD;
          -  Adequate command of the German language&#xD;
&#xD;
          -  PANSS Suspiciousness/persecution &gt;= 3 AND/OR PANSS hallucinations &gt;=3&#xD;
&#xD;
          -  Diagnosis of schizophrenia, schizoaffective disorder or delusional disorder&#xD;
&#xD;
          -  Concurrent psychopharmacological treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute suicidality&#xD;
&#xD;
          -  Acute risk of endangering others&#xD;
&#xD;
          -  No emergency plan (with is formulated during the telephone interview)&#xD;
&#xD;
          -  Disease of the central nervous system with need for treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Westermann, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steffen Moritz, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Bern</name>
      <address>
        <city>Bern</city>
        <zip>3012</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>internet-based intervention</keyword>
  <keyword>e-mental health</keyword>
  <keyword>cognitive behavioural intervention</keyword>
  <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>Delusions</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/NCT02974400
org study id: 159384
nct id: NCT02974400
lead sponsor: 
collaborator: 
has dmc: No
Schizophrenia is a severe mental disorder which is accompanied by an enormous individual and
      societal burden. Despite established efficacy of cognitive behavioral therapy for psychosis
      (CBTp), its dissemination into routine mental health care remains poor. National regulations
      such as the National Institute for Health and Care Excellence (NICE) guideline in the United
      Kingdom recommend that CBTp should be offered to every person with psychotic symptoms, but
      more than 50% do not receive even a single session of CBTp. In Germany, CBTp is virtually not
      represented in the psychotherapy health service. Internet-based cognitive behavioral therapy
      (CBT) in a self-help format has been proven feasible and effective in anxiety and depressive
      disorders. Recently, Internet-based (self-help) interventions are also deployed via
      smartphone apps. The feasibility of Internet-based treatments for people with schizophrenia
      is well documented for Internet-based interventions (e.g., medication management) and also
      reported for smartphone interventions. However, there is a dearth of empirical studies
      precluding a conclusive picture. As far as the investigators know, there is only one study
      encompassing 90 participants with psychosis that investigated an Internet-based intervention
      with symptom-specific, cognitive behavioral interventions, which is from the investigators'
      research group. The unique features of the proposed project are 1) the first-time evaluation
      of a symptom-oriented, CBTp-based self-help treatment for people with psychotic symptoms via
      Internet, enhanced with smartphone assistance. The study is set up as randomized controlled
      trial (RCT) with active treatment versus a wait-list control group. It evaluates a combined
      Internet-based guided self-help treatment for persecutory ideation and auditory verbal
      hallucinations. The active treatment condition consists of access to a self-help website
      including regular written electronic contact with a guide and access to smartphone-based
      interactive worksheets (apps). The trials combine the low-threshold advantages of an online
      approach (e.g., anonymity) with the virtues of a clinical trial (e.g., symptom assessment and
      diagnostic verification via Interview). The primary outcome measure is the Positive and
      Negative Syndrome Scale (PANSS). Secondary outcome measures include self-reported symptom
      measures (Paranoia Checklist; Beliefs About Voices Questionnaire revised), completion rates,
      drop-out from the intervention, general symptomatology, side-effects, and client
      satisfaction. The project will help to answer the empirical question whether CBTp-based
      interventions in a purely Internet-based self-help format are effective. Positive findings
      would pave the way for an easy-to-access treatment option for patients with psychotic
      symptoms who currently are deprived of psychotherapeutic treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Positive and Negative Syndrome Scale (PANSS)
time frame: Change in PANSS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
description: Kay et al. (1987); clinician administered
measure: Paranoia Checklist (PC)
time frame: Change in PC from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
description: Freeman et al. (2005); self-report
measure: Launay-Slade Hallucination Scale (LSHS)
time frame: Change in LSHS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
description: Bentall & Slade (1985); self-report
measure: Patient Health Questionnaire (PHQ-9)
time frame: Change in PHQ-9 from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
description: Spitzer, Kroenke & Williams, 1999; self-report
measure: Incongruence Scale (INK)
time frame: Change in INK from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
description: Grosse Holtforth, Grawe & Tamcan (2004); self-report
measure: Quality of life (WHO-QOL)
time frame: Change in WHO-QOL from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
description: WHO; self-report
arm group label: Internet-based guided self-help
arm group type: Experimental
description: Internet-based, guided, CBT-oriented self-help treatment for persecutory ideation and auditory verbal hallucinations with access to a self-help website including regular written electronic contact with a guide and access to smartphone-based interactive worksheets (8 weeks)
arm group label: Wait-List
arm group type: No Intervention
description: Wait-list control group (8 weeks)
intervention type: Behavioral
intervention name: Internet-based, CBT-oriented, guided self-help
description: The self-help program includes sessions regarding (1) cognitive model, (2) sleep hygiene, (3) mindfulness, (4) meta-cognition, (5) coping with voice hearing, (6) persecutory ideation, (7) worrying, (8) self-esteem, (9) depression, (10) social competence, and (11) relapse prevention.
arm group label: Internet-based guided self-help
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan Westermann, Dr
role: Principal Investigator
affiliation: University of Bern
last name: Steffen Moritz, Prof. Dr.
role: Principal Investigator
affiliation: Universitätsklinikum Hamburg-Eppendorf
facility: 
facility: 
country: Germany
country: Switzerland
responsible party type: Sponsor
mesh term: Hallucinations
mesh term: Schizophrenia
mesh term: Delusions