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Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for People With Psychosis (EviBaS)

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ClinicalTrials.gov Identifier: NCT02974400
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
University of Bern

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Hallucinations Persecutory Delusion Behavioral: Internet-based, CBT-oriented, guided self-help Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for Persecutory Ideation and Auditory Verbal Hallucinations
Actual Study Start Date : December 6, 2016
Actual Primary Completion Date : April 16, 2019
Actual Study Completion Date : April 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Internet-based guided self-help
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)
Behavioral: Internet-based, CBT-oriented, guided self-help
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.

No Intervention: Wait-List
Wait-list control group (8 weeks)



Primary Outcome Measures :
  1. 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) ]
    Kay et al. (1987); clinician administered


Secondary Outcome Measures :
  1. 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) ]
    Freeman et al. (2005); self-report

  2. 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) ]
    Bentall & Slade (1985); self-report

  3. 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) ]
    Spitzer, Kroenke & Williams, 1999; self-report

  4. 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) ]
    Grosse Holtforth, Grawe & Tamcan (2004); self-report

  5. 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) ]
    WHO; self-report



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Electronic informed consent
  • Internet access
  • Adequate command of the German language
  • PANSS Suspiciousness/persecution >= 3 AND/OR PANSS hallucinations >=3
  • Diagnosis of schizophrenia, schizoaffective disorder or delusional disorder
  • Concurrent psychopharmacological treatment

Exclusion Criteria:

  • Acute suicidality
  • Acute risk of endangering others
  • No emergency plan (with is formulated during the telephone interview)
  • Disease of the central nervous system with need for treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974400


Locations
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Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Switzerland
University of Bern
Bern, Switzerland, 3012
Sponsors and Collaborators
University of Bern
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Stefan Westermann, Dr University of Bern
Principal Investigator: Steffen Moritz, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT02974400    
Other Study ID Numbers: 159384
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Keywords provided by University of Bern:
internet-based intervention
e-mental health
cognitive behavioural intervention
Additional relevant MeSH terms:
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Hallucinations
Schizophrenia
Delusions
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Behavioral Symptoms