Clinical Trial: Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for People With Psychosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for Persecutory Ideation and Auditory Verbal Hallucinations

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

Detailed Summary:
Sponsor: University of Bern

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: University of Bern

Dates:
Date Received: November 16, 2016
Date Started: December 2016
Date Completion: December 2018
Last Updated: November 26, 2016
Last Verified: November 2016