An interventional study of Internet-based, CBT-oriented, guided self-help in Schizophrenia, Hallucinations and Persecutory Delusion, sponsored by University of Bern. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-09.
Sponsored by University of Bern · Not applicable, Interventional, and Treatment
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 101 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Wait-list control group (8 weeks)
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.
Positive and Negative Syndrome Scale (PANSS)
Kay et al. (1987); clinician administered
Time frame: Change in PANSS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
Paranoia Checklist (PC)
Freeman et al. (2005); self-report
Time frame: Change in PC from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
Launay-Slade Hallucination Scale (LSHS)
Bentall \& Slade (1985); self-report
Time frame: Change in LSHS from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
Patient Health Questionnaire (PHQ-9)
Spitzer, Kroenke \& Williams, 1999; self-report
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)
Incongruence Scale (INK)
Grosse Holtforth, Grawe \& Tamcan (2004); self-report
Time frame: Change in INK from pre-intervention to post-intervention (i.e. between 1 and 7 days after completion of the last module)
Quality of life (WHO-QOL)
WHO; self-report
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)
Ran from Dec 2016 to primary completion in Apr 2019, 28 months.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 28 months is below that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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