Evaluation of Internet-based Cognitive Behavioral Self-help Treatments for People With Psychosis
- Conditions
- Persecutory DelusionSchizophreniaHallucinations
- Interventions
- Behavioral: Internet-based, CBT-oriented, guided self-help
- Registration Number
- NCT02974400
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet-based guided self-help Internet-based, CBT-oriented, 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)
- Primary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale (PANSS) 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
Name Time Method Quality of life (WHO-QOL) 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
Patient Health Questionnaire (PHQ-9) 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
Paranoia Checklist (PC) 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) 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
Incongruence Scale (INK) 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
Trial Locations
- Locations (2)
University Medical Center Hamburg-Eppendorf
🇩🇪Hamburg, Germany
University of Bern
🇨ðŸ‡Bern, Switzerland