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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02974400
Acronym
EviBaS
Enrollment
101
Registered
2016-11-28
Start date
2016-12-06
Completion date
2019-04-16
Last updated
2019-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallucinations, Persecutory Delusion, Schizophrenia

Keywords

internet-based intervention, e-mental health, cognitive behavioural intervention

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.

Interventions

BEHAVIORALInternet-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.

Sponsors

Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
University of Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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
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
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
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

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026